https://capra.ca/en/blogenhttps://capra.ca/en/blog/precision-healthcare-powered-by-artificial-intelligence-a-global-regulatory-perspective-2025-06-01-1Precision Healthcare Powered by Artificial Intelligence: A Global Regulatory Perspective What is Precision Medicine? The United States (US) Food and...Wed, 02 Jul 2025 00:00:00 -0400https://capra.ca/en/blog/precision-healthcare-powered-by-artificial-intelligence-a-global-regulatory-perspective-2025-06-01-1https://capra.ca/en/blog/insights-from-11-years-of-good-clinical-practice-gcp-inspections-2025-05-13-1Insights from 11 Years of Good Clinical Practice (GCP) Inspections Although only 20% of all GCP inspections are conducted at sponsor sites, the...Tue, 13 May 2025 00:00:00 -0400https://capra.ca/en/blog/insights-from-11-years-of-good-clinical-practice-gcp-inspections-2025-05-13-1https://capra.ca/en/blog/rethinking-cost-sharing-the-need-for-health-insurance-reform-in-the-us-2024-09-15In the U.S., the system designed to protect Americans from the financial devastation of illness often ends up being the very source of that...Sun, 15 Sep 2024 00:00:00 -0400https://capra.ca/en/blog/rethinking-cost-sharing-the-need-for-health-insurance-reform-in-the-us-2024-09-15https://capra.ca/en/blog/value-based-drug-pricing-in-canada-and-its-limitations-2024-08-14Drug pricing is a complex and controversial issue that often sparks debates among patients, pharmaceutical companies, and the government. Prices can...Wed, 14 Aug 2024 00:00:00 -0400https://capra.ca/en/blog/value-based-drug-pricing-in-canada-and-its-limitations-2024-08-14https://capra.ca/en/blog/addressing-underrepresentation-in-clinical-trials-fdas-diversity-action-plan-2024-07-30The U.S. Food and Drug Administration (FDA) released a new draft guidance in June 2024 to enhance the diversity of clinical trial participants. The...Tue, 30 Jul 2024 00:00:00 -0400https://capra.ca/en/blog/addressing-underrepresentation-in-clinical-trials-fdas-diversity-action-plan-2024-07-30https://capra.ca/en/blog/virtual-healthcare-in-canada-2024-07-03“Virtual care” is defined as any “interaction between patients and/or members of their circle of care, occurring remotely, using any forms of...Wed, 03 Jul 2024 00:01:00 -0400https://capra.ca/en/blog/virtual-healthcare-in-canada-2024-07-03https://capra.ca/en/blog/artificial-intelligence-revolutionizing-the-healthcare-industry-2023-10-27What is Artificial Intelligence? Artificial intelligence (AI) is a broad term for a category of algorithms and models that perform tasks and exhibit...Fri, 27 Oct 2023 00:00:00 -0400https://capra.ca/en/blog/artificial-intelligence-revolutionizing-the-healthcare-industry-2023-10-27https://capra.ca/en/blog/technology-continues-to-transform-healthcare-and-the-regulatory-world-2023-09-15Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of...Fri, 15 Sep 2023 00:00:00 -0400https://capra.ca/en/blog/technology-continues-to-transform-healthcare-and-the-regulatory-world-2023-09-15https://capra.ca/en/blog/rare-diseases-and-orphan-drugs-regulatory-framework-in-canada-recent-initiatives-by-government-of-canada-2023-05-15What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and...Mon, 15 May 2023 00:00:00 -0400https://capra.ca/en/blog/rare-diseases-and-orphan-drugs-regulatory-framework-in-canada-recent-initiatives-by-government-of-canada-2023-05-15https://capra.ca/en/blog/health-canada-changes-filing-requirements-for-product-monographs-2023-04-10Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs?...Mon, 10 Apr 2023 00:00:00 -0400https://capra.ca/en/blog/health-canada-changes-filing-requirements-for-product-monographs-2023-04-10https://capra.ca/en/blog/pragmatic-clinical-trials-testing-treatments-in-the-real-world-2022-10-17What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find...Mon, 17 Oct 2022 00:00:00 -0400https://capra.ca/en/blog/pragmatic-clinical-trials-testing-treatments-in-the-real-world-2022-10-17https://capra.ca/en/blog/the-fda-announces-proposed-rule-nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use-june-28-2022-2022-07-19The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket...Tue, 19 Jul 2022 00:00:00 -0400https://capra.ca/en/blog/the-fda-announces-proposed-rule-nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use-june-28-2022-2022-07-19https://capra.ca/en/blog/3d-printing-our-way-to-better-health-care-2022-06-27What is 3D Printing? 3-Dimensional (3D) printing is a process that creates a three-dimensional object by building successive layers of raw material....Mon, 27 Jun 2022 00:00:00 -0400https://capra.ca/en/blog/3d-printing-our-way-to-better-health-care-2022-06-27https://capra.ca/en/blog/digital-therapeutics-reshaping-the-future-of-medicine-2022-05-13Digital Therapeutics – Reshaping the future of medicine What is Digital Therapeutics? With healthcare becoming digital, patients today are more...Fri, 13 May 2022 00:00:00 -0400https://capra.ca/en/blog/digital-therapeutics-reshaping-the-future-of-medicine-2022-05-13https://capra.ca/en/blog/the-need-for-regulatory-innovation-in-canada-a-series-issue-1-2022-05-06The Need for Regulatory Innovation in Canada: A Series (Issue 1) Healthcare innovation has a strong position in Canada. From Insulin to Pacemaker to...Fri, 06 May 2022 00:00:00 -0400https://capra.ca/en/blog/the-need-for-regulatory-innovation-in-canada-a-series-issue-1-2022-05-06https://capra.ca/en/blog/real-world-dataevidence-increasing-use-in-healthcare-for-regulatory-decision-making-2022-04-29Real-World Data/Evidence – Increasing use in Healthcare for Regulatory Decision Making What is Real-World Evidence/Data? The availability of real...Fri, 29 Apr 2022 00:00:00 -0400https://capra.ca/en/blog/real-world-dataevidence-increasing-use-in-healthcare-for-regulatory-decision-making-2022-04-29https://capra.ca/en/blog/biosimilars-and-their-approval-in-canada-2022-03-22BIOSIMILARS AND THEIR APPROVAL IN CANADA Biosimilars are regulated as innovative pharmaceuticals in Canada under Food and Drugs Act and Part C of the...Thu, 24 Mar 2022 00:00:00 -0400https://capra.ca/en/blog/biosimilars-and-their-approval-in-canada-2022-03-22https://capra.ca/en/blog/fdas-new-annual-distribution-reporting-requirement-under-section-510j3-of-the-fdc-act-for-reporting-the-amount-of-commercially-distributed-listed-drugs-and-biological-products-2022-02-14Due date (February 15, 2022) approaching for Reporting the Amount for calendar year 2020 In October 2021, the Food and Drug Administration (FDA)...Fri, 11 Feb 2022 00:00:00 -0500https://capra.ca/en/blog/fdas-new-annual-distribution-reporting-requirement-under-section-510j3-of-the-fdc-act-for-reporting-the-amount-of-commercially-distributed-listed-drugs-and-biological-products-2022-02-14https://capra.ca/en/blog/to-distribute-or-not-to-distribute-health-canadas-guide-to-distributing-drugs-intended-for-the-canadian-market-for-consumption-or-use-outside-canada-2021-11-17Further to Health Canada’s amendments to the Food and Drug Regulations (FDR) to make the provisions under the one-year Interim Order respecting drug...Wed, 17 Nov 2021 00:00:00 -0500https://capra.ca/en/blog/to-distribute-or-not-to-distribute-health-canadas-guide-to-distributing-drugs-intended-for-the-canadian-market-for-consumption-or-use-outside-canada-2021-11-17https://capra.ca/en/blog/health-canada-draft-revised-guidance-documents-on-post-noc-changes-quality-for-consultation-2021-09-30On August 6, 2021, Health Canada issued five draft revised Guidance Documents on Post-Notice of Compliance (NOC) Quality Changes for stakeholder...Thu, 30 Sep 2021 00:00:00 -0400https://capra.ca/en/blog/health-canada-draft-revised-guidance-documents-on-post-noc-changes-quality-for-consultation-2021-09-30https://capra.ca/en/blog/hc-mhra-guideline-increasing-transparency-when-presenting-safety-information-in-the-dsur-2021-08-16On July 6, 2021, Health Canada and the Medicines and Healthcare products Regulatory Agency (MHRA) jointly published a Guideline on how to increase...Tue, 17 Aug 2021 00:00:00 -0400https://capra.ca/en/blog/hc-mhra-guideline-increasing-transparency-when-presenting-safety-information-in-the-dsur-2021-08-16https://capra.ca/en/blog/health-canadas-proposal-for-clinical-trials-regulatory-modernization-2021-07-16On May 20, 2021 Health Canada opened a consultation on its proposal to modernize the regulatory framework for clinical trials related to human drugs,...Fri, 16 Jul 2021 00:00:00 -0400https://capra.ca/en/blog/health-canadas-proposal-for-clinical-trials-regulatory-modernization-2021-07-16https://capra.ca/en/blog/interim-order-no-2-respecting-clinical-trials-for-medical-devices-and-drugs-relating-to-covid-19-2021-06-30In response to the ongoing need for innovative COVID-19 diagnosis, treatment, mitigation, or prevention options, Health Canada announced the approval...Wed, 30 Jun 2021 00:00:00 -0400https://capra.ca/en/blog/interim-order-no-2-respecting-clinical-trials-for-medical-devices-and-drugs-relating-to-covid-19-2021-06-30https://capra.ca/en/blog/amendments-to-the-food-and-drug-regulations-to-replace-the-interim-order-respecting-the-importation-sale-and-advertising-of-drugs-for-use-in-relation-to-covid-19-isad-io-2021-04-29.htmAs the COVID-19 pandemic continues and its unprecedented challenges rapidly evolve, Health Canada’s (HC) agile regulatory measures, called Interim...Thu, 29 Apr 2021 00:00:00 -0400https://capra.ca/en/blog/amendments-to-the-food-and-drug-regulations-to-replace-the-interim-order-respecting-the-importation-sale-and-advertising-of-drugs-for-use-in-relation-to-covid-19-isad-io-2021-04-29.htmhttps://capra.ca/en/blog/how-health-canadas-draft-guidance-on-electronic-media-in-prescription-drug-labelling-may-affect-drug-advertising-2021-04-16.htmHealth Canada (HC) launched a consultation on the 'DRAFT Guidance for Electronic Media in Prescription Drug Labelling' on March 12, 2021 and will...Fri, 16 Apr 2021 00:00:00 -0400https://capra.ca/en/blog/how-health-canadas-draft-guidance-on-electronic-media-in-prescription-drug-labelling-may-affect-drug-advertising-2021-04-16.htmhttps://capra.ca/en/blog/drug-reimbursement-aligned-review-process-by-cadth-2020-10-14.htmIn an effort to make Pharmaceutical Reviews program more cohesive, transparent, and responsive, on September 30, 2020, The Canadian Agency for Drugs...Wed, 14 Oct 2020 00:00:00 -0400https://capra.ca/en/blog/drug-reimbursement-aligned-review-process-by-cadth-2020-10-14.htmhttps://capra.ca/en/blog/non-medical-masks-or-face-coverings-regulatory-considerations-in-the-context-of-covid-19-2020-08-03.htmOn July 24, 2020, Health Canada published a notice to industry that explains circumstances under which non-medical masks or face coverings would be...Mon, 03 Aug 2020 00:00:00 -0400https://capra.ca/en/blog/non-medical-masks-or-face-coverings-regulatory-considerations-in-the-context-of-covid-19-2020-08-03.htmhttps://capra.ca/en/blog/step-2b-draft-q3cr8-impurities-guideline-for-residual-solvents-released-for-public-consultation-2020-07-06.htmThe ICH Q3C core guideline was finalized under Step 4 in July 1997, providing recommendations on the use of less toxic solvents in the manufacture of...Mon, 06 Jul 2020 00:00:00 -0400https://capra.ca/en/blog/step-2b-draft-q3cr8-impurities-guideline-for-residual-solvents-released-for-public-consultation-2020-07-06.htmhttps://capra.ca/en/blog/an-update-from-nnhpd-release-of-new-web-pla-form-version-4-2020-06-22.htmAuthor: Bhavesh Patel Quick Facts about Natural Health Products in Canada: Health Canada regulates natural health products (NHPs) so that Canadians...Mon, 22 Jun 2020 00:00:00 -0400https://capra.ca/en/blog/an-update-from-nnhpd-release-of-new-web-pla-form-version-4-2020-06-22.htmhttps://capra.ca/en/blog/interim-order-to-facilitate-covid-19-clinical-trials-related-to-drugs-and-medical-device-2020-06-05.htmAuthor: Preetha Prabhu On May 23, 2020, the Minister of Health signed an Interim Order (IO) Respecting Clinical Trials for Medical Devices and Drugs...Fri, 05 Jun 2020 00:00:00 -0400https://capra.ca/en/blog/interim-order-to-facilitate-covid-19-clinical-trials-related-to-drugs-and-medical-device-2020-06-05.htmhttps://capra.ca/en/blog/interim-labelling-of-products-during-covid-19-hand-sanitizers-disinfectants-soaps-and-cleaning-products-2020-05-19.htmAuthor: Preetha Prabhu According to Statistics Canada, demand for hand sanitizer increased by 735% for the week ending March 14, 2020, relative to...Tue, 19 May 2020 00:00:00 -0400https://capra.ca/en/blog/interim-labelling-of-products-during-covid-19-hand-sanitizers-disinfectants-soaps-and-cleaning-products-2020-05-19.htmhttps://capra.ca/en/blog/distribution-of-low-risk-dinnpn-products-as-samples-2020-05-04.htmAuthor: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. Beginning July 1, 2020 , industry will be able to distribute...Mon, 04 May 2020 00:00:00 -0400https://capra.ca/en/blog/distribution-of-low-risk-dinnpn-products-as-samples-2020-05-04.htmhttps://capra.ca/en/blog/health-canada-notice-management-of-clinical-trials-during-covid-19-2020-04-27.htmAuthor: Preetha Prabhu On Apr. 22, 2020, Health Canada published a notice to clinical trial sponsors regarding management of clinical trials during...Mon, 27 Apr 2020 00:00:00 -0400https://capra.ca/en/blog/health-canada-notice-management-of-clinical-trials-during-covid-19-2020-04-27.htmhttps://capra.ca/en/blog/the-ever-changing-hard-surface-disinfectant-landscape-in-covid-19-times-2020-04-14.htmAuthor: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. These days, the world of hard surface disinfectants and pathway to...Tue, 14 Apr 2020 00:00:00 -0400https://capra.ca/en/blog/the-ever-changing-hard-surface-disinfectant-landscape-in-covid-19-times-2020-04-14.htmhttps://capra.ca/en/blog/regulatory-enrolment-process-mandatory-effective-october-1-2020-2020-04-06.htmAuthor: Preetha Prabhu On Mar. 30, 2020, Health Canada published a notice that as of October 1, 2020 use of the Regulatory Enrolment Process (REP)...Mon, 06 Apr 2020 00:00:00 -0400https://capra.ca/en/blog/regulatory-enrolment-process-mandatory-effective-october-1-2020-2020-04-06.htmhttps://capra.ca/en/blog/health-canadas-interim-expedited-licensing-approach-for-the-production-and-distribution-of-alcohol-based-hand-sanitizers-2020-04-01.htmAuthor: Joe McCarthy , Dell Tech Laboratories Ltd. To facilitate the safe and efficient production of Natural Health Product (NHP) hand sanitizers...Wed, 01 Apr 2020 00:00:00 -0400https://capra.ca/en/blog/health-canadas-interim-expedited-licensing-approach-for-the-production-and-distribution-of-alcohol-based-hand-sanitizers-2020-04-01.htmhttps://capra.ca/en/blog/paab-update-on-digitization-of-advertising-promotional-systems-aps-2020-03-18.htmAuthor: Preetha Prabhu In the light of evolving COVID-19, some manufacturers are modifying how their drug representatives interact with healthcare...Wed, 18 Mar 2020 00:00:00 -0400https://capra.ca/en/blog/paab-update-on-digitization-of-advertising-promotional-systems-aps-2020-03-18.htmhttps://capra.ca/en/blog/clinical-trial-regulatory-activities-in-ectd-2020-03-02.htmAuthor: Preetha Prabhu On February 19, 2020, Health Canada announced that the pilot for Clinical Trial regulatory activities in electronic Common...Mon, 02 Mar 2020 00:00:00 -0500https://capra.ca/en/blog/clinical-trial-regulatory-activities-in-ectd-2020-03-02.htmhttps://capra.ca/en/blog/information-on-nitrosamine-impurity-2020-02-18.htmAuthor : Preetha Prabhu In July 2018 Health Canada first became aware of the presence of nitrosamine impurity, N-nitrosodimethylamine (NDMA) in...Tue, 18 Feb 2020 00:00:00 -0500https://capra.ca/en/blog/information-on-nitrosamine-impurity-2020-02-18.htmhttps://capra.ca/en/blog/the-emerging-viral-pathogen-2019-ncov-coronavirus-and-what-it-means-for-broad-spectrum-virucide-disinfectants-2020-02-10.htmAuthor: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. On January 30, 2020 the World Health Organization (WHO) declared...Mon, 10 Feb 2020 00:00:00 -0500https://capra.ca/en/blog/the-emerging-viral-pathogen-2019-ncov-coronavirus-and-what-it-means-for-broad-spectrum-virucide-disinfectants-2020-02-10.htmhttps://capra.ca/en/blog/canadian-product-monograph-upcoming-changes-implementation-timeline-2020-02-03.htmAuthor: Preetha Prabhu Health Canada is committed towards improving the accessibility and quality of drug product information for Canadians by making...Mon, 03 Feb 2020 00:00:00 -0500https://capra.ca/en/blog/canadian-product-monograph-upcoming-changes-implementation-timeline-2020-02-03.htmhttps://capra.ca/en/blog/software-as-a-medical-device-samd-definition-and-classification-2020-01-27.htmAuthor: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. The Medical Devices Regulations have been established under the...Mon, 27 Jan 2020 00:00:00 -0500https://capra.ca/en/blog/software-as-a-medical-device-samd-definition-and-classification-2020-01-27.htmhttps://capra.ca/en/blog/cost-recovery-fees-in-respect-of-drugs-and-medical-devices-2020-01-20.htmAuthor: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. After two years of extensive engagement, new fees and policies will...Mon, 20 Jan 2020 00:00:00 -0500https://capra.ca/en/blog/cost-recovery-fees-in-respect-of-drugs-and-medical-devices-2020-01-20.htmhttps://capra.ca/en/blog/health-canada-collaborates-with-us-and-australian-regulators-through-project-orbis-a-framework-for-concurrent-review-of-oncology-products-2020-01-10.htmAuthor: Preetha Prabhu On Dec. 6, 2019, Health Canada issued a News Release titled “International collaboration among Canadian, U.S. and Australian...Fri, 10 Jan 2020 00:00:00 -0500https://capra.ca/en/blog/health-canada-collaborates-with-us-and-australian-regulators-through-project-orbis-a-framework-for-concurrent-review-of-oncology-products-2020-01-10.htmhttps://capra.ca/en/blog/changes-to-the-cosmetic-ingredient-hotlist-2019-12-20.htmAuthor: Teri Dickinson, Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. The Cosmetic Ingredient Hotlist is an administrative tool that...Fri, 20 Dec 2019 00:00:00 -0500https://capra.ca/en/blog/changes-to-the-cosmetic-ingredient-hotlist-2019-12-20.htmhttps://capra.ca/en/blog/biosimilar-pharmaceuticals-in-canada-fact-sheet-2019-11-13.htmAuthor: Bhavesh Patel This past August, Health Canada published a document titled “Biosimilar Biologic Drugs in Canada: Fact Sheet” to provide a...Wed, 13 Nov 2019 00:00:00 -0500https://capra.ca/en/blog/biosimilar-pharmaceuticals-in-canada-fact-sheet-2019-11-13.htmhttps://capra.ca/en/blog/health-canada-issues-important-safety-information-for-ranitidine-products-2019-11-04.htmBy: Pinky Mazumder On September 13, 2019 Health Canada issued an Important Safety Information to the general public titled “Health Canada assessing...Mon, 04 Nov 2019 00:00:00 -0500https://capra.ca/en/blog/health-canada-issues-important-safety-information-for-ranitidine-products-2019-11-04.htmhttps://capra.ca/en/blog/regulatory-enrolment-process-rep-pilot-for-clinical-trials-2019-10-15.htmAuthor: Bhavesh Patel Health Canada intends to launch a pilot project for clinical trial regulatory activities on November 1, 2019. The pilot project...Tue, 15 Oct 2019 00:00:00 -0400https://capra.ca/en/blog/regulatory-enrolment-process-rep-pilot-for-clinical-trials-2019-10-15.htmhttps://capra.ca/en/blog/health-canada-drug-and-medical-device-highlights-2018-2019-07-15.htmAuthor: Bhavesh Patel Health Canada published the report on drugs for human use, medical devices and drugs for veterinary use. The report sets out...Mon, 15 Jul 2019 00:00:00 -0400https://capra.ca/en/blog/health-canada-drug-and-medical-device-highlights-2018-2019-07-15.htmhttps://capra.ca/en/blog/health-canada-notice-on-ich-q3d-r1-the-guideline-for-elemental-impurities-2019-07-03.htmBy: Pinky Mazumder On May 31st, 2019, Health Canada issued a Notice titled the Release of the Finalised Guideline for ICH Q3D (R1): Guideline for...Wed, 03 Jul 2019 00:00:00 -0400https://capra.ca/en/blog/health-canada-notice-on-ich-q3d-r1-the-guideline-for-elemental-impurities-2019-07-03.htmhttps://capra.ca/en/blog/special-access-program-draft-guidance-2019-06-18.htmAuthor: Karen Zhou The Food and Drug Regulations (“FDR”) contains emergency provisions (Part C, Division 8, sections C.08.010 and C.08.011 of the...Tue, 18 Jun 2019 00:00:00 -0400https://capra.ca/en/blog/special-access-program-draft-guidance-2019-06-18.htmhttps://capra.ca/en/blog/improving-access-to-clinical-data-2019-05-27.htmAuthor: Karen Zhou Health Canada has published final regulations that allow for the public release of clinical data on drugs and medical devices....Mon, 27 May 2019 00:00:00 -0400https://capra.ca/en/blog/improving-access-to-clinical-data-2019-05-27.htmhttps://capra.ca/en/blog/health-canadas-scanning-and-consultations-on-whats-next-for-health-product-regulation-2019-05-06.htmBy: Pinky Mazumder With the rapid evolution of healthcare technologies, Health Canada undertook a scanning exercise to identify key drivers involved...Mon, 06 May 2019 00:00:00 -0400https://capra.ca/en/blog/health-canadas-scanning-and-consultations-on-whats-next-for-health-product-regulation-2019-05-06.htmhttps://capra.ca/en/blog/health-canada-getting-tougher-on-opioid-and-illegal-advertising-2019-04-29.htmAuthor: John Wong, Director, Regulatory Drug Advertising & Promotion, TPIReg/Inomar Strategies In light of the on-going and escalating opioid crisis,...Mon, 29 Apr 2019 00:00:00 -0400https://capra.ca/en/blog/health-canada-getting-tougher-on-opioid-and-illegal-advertising-2019-04-29.htmhttps://capra.ca/en/blog/guidance-document-regarding-administrative-processing-of-submissions-and-applications-human-or-disinfectant-drugs-2019-04-23.htmAuthor: Bhavesh Patel, C. Chem. Health Canada recently published a guidance document to clarify the requirements for eligible drug submissions and...Tue, 23 Apr 2019 00:00:00 -0400https://capra.ca/en/blog/guidance-document-regarding-administrative-processing-of-submissions-and-applications-human-or-disinfectant-drugs-2019-04-23.htmhttps://capra.ca/en/blog/release-of-draft-guidance-document-regulatory-requirements-for-drug-identification-numbers-dins-2019-04-08.htmAuthor: Karen Zhou Health Canada recently released a draft guidance on regulatory requirements for Drug Identification Numbers (DINs). The intent of...Mon, 08 Apr 2019 00:00:00 -0400https://capra.ca/en/blog/release-of-draft-guidance-document-regulatory-requirements-for-drug-identification-numbers-dins-2019-04-08.htmhttps://capra.ca/en/blog/health-canada-notice-on-the-discontinuation-of-acknowledgement-letters-for-regulatory-activities-2019-03-27.htmAuthor: Pinky Mazumder On January 30, 2019, Health Canada published a Notice announcing a proposal to discontinue acknowledgement letters...Wed, 27 Mar 2019 00:00:00 -0400https://capra.ca/en/blog/health-canada-notice-on-the-discontinuation-of-acknowledgement-letters-for-regulatory-activities-2019-03-27.htmhttps://capra.ca/en/blog/canadian-cannabis-survey-2018-2019-03-12.htmHealth Canada has been actively collecting data to better understand how Canadians view and use cannabis.Tue, 12 Mar 2019 00:00:00 -0400https://capra.ca/en/blog/canadian-cannabis-survey-2018-2019-03-12.htmhttps://capra.ca/en/blog/health-canada-assessment-suggests-that-talc-may-be-harmful-to-human-health-2019-03-04.htmIn late 2018, Health Canada and Environment and Climate Change Canada announced the completion of the draft screening assessment of talc. Talc (Chemical Abstracts Service Registry Number 14807-96-6) is a naturally occurring mineral typically found in consumer products (e.g. cosmetics, natural health products, talcum powder, food, plastics, paper).Mon, 04 Mar 2019 00:00:00 -0500https://capra.ca/en/blog/health-canada-assessment-suggests-that-talc-may-be-harmful-to-human-health-2019-03-04.htmhttps://capra.ca/en/blog/health-canada-requests-feedback-on-potential-impacts-and-uses-if-company-names-were-added-to-the-generic-submissions-under-review-list-2019-02-25.htmHealth Canada has recently requested feedback on a Phase III premarket transparency initiative to include the name of the sponsor on the list of new drug submissions and supplements for new uses currently under review.Mon, 25 Feb 2019 00:00:00 -0500https://capra.ca/en/blog/health-canada-requests-feedback-on-potential-impacts-and-uses-if-company-names-were-added-to-the-generic-submissions-under-review-list-2019-02-25.htmhttps://capra.ca/en/blog/improving-safety-effectiveness-and-quality-the-medical-device-action-plan-2019-02-13.htmIn a sweeping move to strengthen the safety, effectiveness and quality of medical devices, Health Canada has rolled out a three part Medical Device Action Plan for 2019.Wed, 13 Feb 2019 00:00:00 -0500https://capra.ca/en/blog/improving-safety-effectiveness-and-quality-the-medical-device-action-plan-2019-02-13.htmhttps://capra.ca/en/blog/summary-of-annual-trends-of-adverse-reaction-case-reports-submitted-to-health-canada-2019-02-05.htmWith the purpose of protecting the health of Canadians and monitoring the safety of products on the market, Health Canada collects reports of health product adverse events from manufacturers/importers as well as from healthcare professionals.Tue, 05 Feb 2019 00:00:00 -0500https://capra.ca/en/blog/summary-of-annual-trends-of-adverse-reaction-case-reports-submitted-to-health-canada-2019-02-05.htmhttps://capra.ca/en/blog/post-noc-level-iii-change-updates-2019-01-07.htmA post-NOC change is any change made to a new drug that has received a notice of compliance (NOC) pursuant to C.08.004 of the Food and Drug Regulations.Mon, 07 Jan 2019 00:00:00 -0500https://capra.ca/en/blog/post-noc-level-iii-change-updates-2019-01-07.htmhttps://capra.ca/en/blog/cybersecurity-draft-guidance-document-2019-01-04.htmMedical devices play a pivotal and ever increasing role in improving access to care for patients. Through data exchange with network environments, medical devices facilitate timely diagnoses and treatments and improve access to healthcare information.  The tradeoff is that that devices can become vulnerable to cyberattacks. Fri, 04 Jan 2019 00:00:00 -0500https://capra.ca/en/blog/cybersecurity-draft-guidance-document-2019-01-04.htmhttps://capra.ca/en/blog/proposed-amendments-to-regulations-under-the-ontario-drug-benefit-act-and-the-drug-interchangeability-and-dispensing-fee-act-2018-11-26.htmThe Ministry of Health & Long-Term Care recently announced proposed amendments to the regulatory scheme affecting private label drug products.Mon, 26 Nov 2018 00:00:00 -0500https://capra.ca/en/blog/proposed-amendments-to-regulations-under-the-ontario-drug-benefit-act-and-the-drug-interchangeability-and-dispensing-fee-act-2018-11-26.htmhttps://capra.ca/en/blog/software-as-medical-devices-samd-where-to-go-from-here-2018-11-16.htmIn an era of mobile apps on smartphones and tablets, Canada’s current software regulatory framework is long overdue for revision. Because the healthcare industry has become more reliant on software, Health Canada has recognized the need to revisit the current medical device regulatory framework as it applies to software as medical devices.Fri, 16 Nov 2018 00:00:00 -0500https://capra.ca/en/blog/software-as-medical-devices-samd-where-to-go-from-here-2018-11-16.htmhttps://capra.ca/en/blog/device-advice-health-canada-launching-a-new-pilot-project-to-formalize-regulatory-advice-framework-for-medical-device-manufacturers-2018-11-06.htmHealth Canada recently announced it is the process of formalizing a meeting framework called "Device Advice: Pre-Clinical Meetings", where medical device manufacturers will be able to receive advice and recommendations for investigational testing protocols.Tue, 06 Nov 2018 00:00:00 -0500https://capra.ca/en/blog/device-advice-health-canada-launching-a-new-pilot-project-to-formalize-regulatory-advice-framework-for-medical-device-manufacturers-2018-11-06.htmhttps://capra.ca/en/blog/health-canada-update-on-investigational-testing-authorizations-for-medical-devices-2018-10-29.htmInvestigational Testing Authorization (ITA) issued by Health Canada, allows for the testing of Class II, III, and IV medical devices with human subjects. For unlicensed devices, the submission of an ITA is required to establish new safety and effectiveness data, however, ITAs are also required for licenced medical devices when establishing safety and effectiveness for new indications.Mon, 29 Oct 2018 00:00:00 -0400https://capra.ca/en/blog/health-canada-update-on-investigational-testing-authorizations-for-medical-devices-2018-10-29.htmhttps://capra.ca/en/blog/toward-global-harmonization-health-canada-to-adopt-imdrf-table-of-contents-format-for-class-iii-and-iv-applications-2018-10-22.htmIn another move toward global harmonization, by April 1, 2019, medical device manufacturers will be required to submit premarket applications for Class III and Class IV applications in Canada in either the International Medical Device Regulators Forum (IMDRF) table of contents (ToC) format or Health Canada format.Mon, 22 Oct 2018 00:00:00 -0400https://capra.ca/en/blog/toward-global-harmonization-health-canada-to-adopt-imdrf-table-of-contents-format-for-class-iii-and-iv-applications-2018-10-22.htmhttps://capra.ca/en/blog/the-long-awaited-legalization-of-cannabis-in-canada-2018-10-16.htmOn October 17th, 2018, the long-awaited legalization of cannabis will come into effect.Tue, 16 Oct 2018 00:00:00 -0400https://capra.ca/en/blog/the-long-awaited-legalization-of-cannabis-in-canada-2018-10-16.htmhttps://capra.ca/en/blog/upcoming-guidance-development-on-the-licensing-requirements-for-3d-printed-devices-2018-10-09.htmHealth Canada recently announced the development of a draft guidance document to assist medical device manufacturers seeking to license 3D-printed devices.Tue, 09 Oct 2018 00:00:00 -0400https://capra.ca/en/blog/upcoming-guidance-development-on-the-licensing-requirements-for-3d-printed-devices-2018-10-09.htmhttps://capra.ca/en/blog/certificate-of-supplementary-protection-csp-updated-guidance-2018-09-25.htmHealth Canada recently announced an update to Guidance Document: Certificate of Supplementary Protection Regulations. The purpose of the guidance is to outline the Certificate of Supplementary Protection (CSP) application process, the service standards, and roles and responsibilities of both applicants and the Therapeutic Products Directorate (TPD).Tue, 25 Sep 2018 00:00:00 -0400https://capra.ca/en/blog/certificate-of-supplementary-protection-csp-updated-guidance-2018-09-25.htmhttps://capra.ca/en/blog/health-canada-plan-to-phase-out-most-uses-of-clothianidin-and-thiamethoxam-2018-09-18.htmNeonicotinoids are a class of pesticides used to control insects on a variety of agricultural crops, including seed treatments, and on turf and ornamental plants.Tue, 18 Sep 2018 00:00:00 -0400https://capra.ca/en/blog/health-canada-plan-to-phase-out-most-uses-of-clothianidin-and-thiamethoxam-2018-09-18.htmhttps://capra.ca/en/blog/vanessas-law-taking-a-first-look-2018-09-10.htmVanessa’s Law (Protecting Canadians from Unsafe Drugs Act), first enacted in 2014, added section 21.1(3) to Canada’s Food and Drugs Act to permit the Minister of Health to disclose confidential business information about a therapeutic product in certain circumstances. For the first time since the 2014 amendment, a court was called upon to interpret and apply Vanessa’s Law. Doshi v. Canada represents the first such judicial consideration.Mon, 10 Sep 2018 00:00:00 -0400https://capra.ca/en/blog/vanessas-law-taking-a-first-look-2018-09-10.htmhttps://capra.ca/en/blog/guidance-on-notifying-health-canada-of-foreign-actions-2018-08-27.htmThe guidance document on Notifying Health Canada of Foreign Actions (the “Guidance Document”) is intended to help Market Authorization Holders (“MAH”) of a Drug Identification Number (“DIN”) or Notice of Compliance (“NOC”) to maintain compliance. Per the Food and Drug Regulations, it is a requirement for a MAH to inform Health Canada of foreign regulatory actions relevant to its products marketed in Canada.Mon, 27 Aug 2018 00:00:00 -0400https://capra.ca/en/blog/guidance-on-notifying-health-canada-of-foreign-actions-2018-08-27.htmhttps://capra.ca/en/blog/strengthening-post-market-surveillance-and-risk-management-of-medical-devices-in-canada-2018-08-20.htmHealth Canada recently informed stakeholders, in particular manufacturers and importers of medical devices, of its intent to propose regulatory changes to strengthen post-market surveillance and risk management of medical devices in Canada.Mon, 20 Aug 2018 00:00:00 -0400https://capra.ca/en/blog/strengthening-post-market-surveillance-and-risk-management-of-medical-devices-in-canada-2018-08-20.htmhttps://capra.ca/en/blog/health-canada-transition-to-global-medical-device-nomenclature-2018-08-09.htmHealth Canada has announced that it is initiating the transition to the Global Medical Device Nomenclature (GMDN) as a medical device categorization method. The goal of this initiative is to improve the availability, access, and quality of information available on medical devices in CanadaThu, 09 Aug 2018 00:00:00 -0400https://capra.ca/en/blog/health-canada-transition-to-global-medical-device-nomenclature-2018-08-09.htmhttps://capra.ca/en/blog/antimicrobial-resistance-and-health-canadas-pathogens-of-interest-list-2018-08-02.htmAntimicrobial resistance is currently recognized as a worldwide public health concern due to difficulty in treatment. In response, Health Canada is preparing to establish new regulatory tools and policies to help expedite the review process of therapeutic products indicated to target such pathogens and better address public health concerns.Thu, 02 Aug 2018 00:00:00 -0400https://capra.ca/en/blog/antimicrobial-resistance-and-health-canadas-pathogens-of-interest-list-2018-08-02.htmhttps://capra.ca/en/blog/ich-e18-genomic-sampling-and-management-of-genomic-data-2018-07-23.htmHealth Canada recently announced the implementation of ICH guidance E18: Genomic Sampling and Management of Genomic Data (the “Guidance”).Mon, 23 Jul 2018 00:00:00 -0400https://capra.ca/en/blog/ich-e18-genomic-sampling-and-management-of-genomic-data-2018-07-23.htmhttps://capra.ca/en/blog/consultation-on-prescription-drug-transparency-2018-07-19.htmFrom September 28th to October 28th 2017, the Therapeutic Products Directorate (TPD) of Health Canada held an online consultation on five proposed initiatives to promote in the approval process for prescription pharmaceuticals.Thu, 19 Jul 2018 00:00:00 -0400https://capra.ca/en/blog/consultation-on-prescription-drug-transparency-2018-07-19.htmhttps://capra.ca/en/blog/final-notice-classification-of-dental-plaque-disclosing-products-as-drugs-2018-07-09.htmEffective immediately, no new dental plaque-disclosing product will be allowed in the marketplace without a DIN or an NPN.Mon, 09 Jul 2018 00:00:00 -0400https://capra.ca/en/blog/final-notice-classification-of-dental-plaque-disclosing-products-as-drugs-2018-07-09.htmhttps://capra.ca/en/blog/australia-canada-singapore-switzerland-acss-consortium-new-chemical-entities-work-sharing-trial-phase-i-2018-06-27.htmThe Australia Canada Singapore Switzerland (ACSS) Consortium was established to foster collaboration and synergy between regulatory authorities to address common scientific and regulatory challenges. The consortium consists of several working groups with various projects that aim to address current regulatory issues such as timely access to safe therapeutic products within a limited resource capacity.Wed, 27 Jun 2018 00:00:00 -0400https://capra.ca/en/blog/australia-canada-singapore-switzerland-acss-consortium-new-chemical-entities-work-sharing-trial-phase-i-2018-06-27.htmhttps://capra.ca/en/blog/health-canada-notice-on-ectd-submission-of-master-files-2018-06-19.htmOn May 7, 2018 Health Canada published a notice announcing the start of a 90-day consultation on the submission of Master Files in eCTD format.Tue, 19 Jun 2018 00:00:00 -0400https://capra.ca/en/blog/health-canada-notice-on-ectd-submission-of-master-files-2018-06-19.htmhttps://capra.ca/en/blog/medical-device-single-audit-program-reduction-of-audit-times-for-small-sized-enterprises-update-2018-06-12.htmHealth Canada is continuing to work towards the target date of January 1, 2019 to transition to MDSAP Quality Management System certificates being accepted for medical device licence applications.Tue, 12 Jun 2018 00:00:00 -0400https://capra.ca/en/blog/medical-device-single-audit-program-reduction-of-audit-times-for-small-sized-enterprises-update-2018-06-12.htmhttps://capra.ca/en/blog/health-canada-implements-ich-guidance-e11r1-addendum-clinical-investigation-of-medicinal-products-in-the-pediatric-population-2018-06-06.htmHealth Canada has announced the implementation of the ICH guidance E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (the “Guidance”). In implementing the Guidance, Health Canada endorses the principles and practices described in the addendum.Wed, 06 Jun 2018 00:00:00 -0400https://capra.ca/en/blog/health-canada-implements-ich-guidance-e11r1-addendum-clinical-investigation-of-medicinal-products-in-the-pediatric-population-2018-06-06.htmhttps://capra.ca/en/blog/health-canada-adapts-to-digital-health-technologies-2018-05-29.htmDigital health technologies are a rapidly growing area in the area of healthcare. These technologies encompass a wide range of products, from single software applications to wearables, and to hardware systems that can been connected to smartphones and computers.Tue, 29 May 2018 00:00:00 -0400https://capra.ca/en/blog/health-canada-adapts-to-digital-health-technologies-2018-05-29.htmhttps://capra.ca/en/blog/release-of-proposed-imdrf-document-definitions-for-personalized-medical-devices-2018-05-23.htmThe International Medical Device Regulators Forum (IMDRF) recently published a Proposed Guidance Document titled Definitions for Personalized Medical Devices (the “Guidance”). The Document is open for public consultation and has been posted on the IMDRF website for comments from the public.Wed, 23 May 2018 00:00:00 -0400https://capra.ca/en/blog/release-of-proposed-imdrf-document-definitions-for-personalized-medical-devices-2018-05-23.htmhttps://capra.ca/en/blog/health-canada-continues-to-tweak-requirements-for-mdsap-transition-2018-05-14.htmManufacturers who sell medical devices in the Canadian market are required to submit MDSAP certificates by December 31, 2018. The Medical Device Single Audit Program (MDSAP) is an international harmonization initiative that allows a single audit to meet the regulatory requirements of five jurisdictions (Canada, United States, Brazil, Australia and Japan).Mon, 14 May 2018 00:00:00 -0400https://capra.ca/en/blog/health-canada-continues-to-tweak-requirements-for-mdsap-transition-2018-05-14.htmhttps://capra.ca/en/blog/health-canada-notice-on-ich-selection-and-justification-of-starting-materials-for-the-manufacture-of-drug-substances-2018-05-09.htmOn April 4th, 2018 Heath Canada issued a Notice to announce its implementation of the ICH Q11 final guidance document on Questions and Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances. This version of ICH Q11 Question and Answers was initially published in August 23, 2017 by the ICH Expert Working Group.Wed, 09 May 2018 00:00:00 -0400https://capra.ca/en/blog/health-canada-notice-on-ich-selection-and-justification-of-starting-materials-for-the-manufacture-of-drug-substances-2018-05-09.htmhttps://capra.ca/en/blog/health-canada-guideline-for-residual-solvents-2018-05-02.htmHealth Canada recently announced the implementation of the ICH Guidance “Q3C(R6) Impurities: Guideline for Residual Solvents” (the “Guidance”).Wed, 02 May 2018 00:00:00 -0400https://capra.ca/en/blog/health-canada-guideline-for-residual-solvents-2018-05-02.htmhttps://capra.ca/en/blog/the-australia-canada-singapore-switzerland-acss-consortium-2018-04-23.htmThe creation of the Consortium allows these regulatory agencies to discuss ways to enhance and even align the regulatory reviews of certain drug products.Mon, 23 Apr 2018 00:00:00 -0400https://capra.ca/en/blog/the-australia-canada-singapore-switzerland-acss-consortium-2018-04-23.htmhttps://capra.ca/en/blog/administrative-processing-of-submissions-and-applications-human-or-disinfectant-drugs-2018-04-18.htmOn March 1, 2018, the guidance document “Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs” (the “Guidance Document”) came into effect. The Guidance Document applies to drug submissions and applications involving biologics, radiopharmaceuticals, human pharmaceuticals and disinfectants regulated under the Food and Drugs Act. The coming into effect of the Guidance Document will be April 1, 2019 in respect of disinfectant drugs.Wed, 18 Apr 2018 00:00:00 -0400https://capra.ca/en/blog/administrative-processing-of-submissions-and-applications-human-or-disinfectant-drugs-2018-04-18.htmhttps://capra.ca/en/blog/cadth-revisions-to-the-biosimilar-review-process-and-resubmission-2018-04-11.htmIn late 2017, the Canadian Agency for Drugs and Technologies in Health (“CADTH”) announced an open consultation on proposed changes to the Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (“pCODR”) for the review of biosimilar drug products. The consultation also addressed the resubmission eligibility criteria for drugs subject to CDR or pCODR along with various administrative changes. On February 2018, CADTH announced new operational changes resulting from the consultation and to enhance the drug review process.Wed, 11 Apr 2018 00:00:00 -0400https://capra.ca/en/blog/cadth-revisions-to-the-biosimilar-review-process-and-resubmission-2018-04-11.htmhttps://capra.ca/en/blog/regulatory-enrollment-process-and-the-use-of-the-common-electronic-submission-gateway-for-medical-devices-2018-04-02.htmHealth Canada is considering a pilot of the Regulatory Enrollment Process (“REP”) using the Common Electronic Submission Gateway (“CESG”) for Medical Device applications in Summer 2018.Mon, 02 Apr 2018 00:00:00 -0400https://capra.ca/en/blog/regulatory-enrollment-process-and-the-use-of-the-common-electronic-submission-gateway-for-medical-devices-2018-04-02.htmhttps://capra.ca/en/blog/health-canadas-adoption-of-ich-m7-2018-03-20.htmOn January 19, 2018 Health Canada announced the adoption of the ICH guidance on M7: The Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (the “Guidance”). The Guidance was prepared by the ICH and reviewed by the regulatory bodies during consultations. By adopting the Guidance, Health Canada has endorsed the principles within.Tue, 20 Mar 2018 00:00:00 -0400https://capra.ca/en/blog/health-canadas-adoption-of-ich-m7-2018-03-20.htmhttps://capra.ca/en/blog/health-sector-payment-transparency-act-2017-new-regulation-2018-03-12.htmThe Ministry of Health and Long-Term Care for the Province of Ontario recently published draft Regulations for the recently enacted Health Sector Payment Transparency Act, 2017 (“HSPTA”). The HSPTA is intended to strengthen transparency in the financial relationships that exist within Ontario's health care system for the ultimate purpose of increasing public trust and confidence.Mon, 12 Mar 2018 00:00:00 -0400https://capra.ca/en/blog/health-sector-payment-transparency-act-2017-new-regulation-2018-03-12.htmhttps://capra.ca/en/blog/ich-draft-on-technical-and-regulatory-considerations-for-pharmaceutical-product-lifecycle-management-q12-2018-03-05.htmOn November 16, 2017 the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) published a draft guidance on Q12 titled, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guidance was established to address certain technical and regulatory gaps found during consultations concerning other ICH Quality guidelines, such as Q8, Q9, Q10, and Q11.Mon, 05 Mar 2018 00:00:00 -0500https://capra.ca/en/blog/ich-draft-on-technical-and-regulatory-considerations-for-pharmaceutical-product-lifecycle-management-q12-2018-03-05.htmhttps://capra.ca/en/blog/pan-canadian-pharmaceutical-alliance-for-generic-drugs-2018-02-26.htmAll 13 Provinces and Territories have been working together to achieve greater value for brand name and generic drugs for publicly funded drug programs. These initiatives, formerly known as the Pan-Canadian Pricing Alliance and the Generic Value Price Initiative, are now referenced collectively as the pan-Canadian Pharmaceutical Alliance (pCPA).Mon, 26 Feb 2018 00:00:00 -0500https://capra.ca/en/blog/pan-canadian-pharmaceutical-alliance-for-generic-drugs-2018-02-26.htmhttps://capra.ca/en/blog/validation-rules-for-regulatory-transactions-submitted-in-the-electronic-common-technical-document-ectd-format-2018-02-20.htmLate last year, Health Canada announced the revised validation rules for regulatory transactions in the electronic Common Technical Document (“eCTD”) format.Tue, 20 Feb 2018 00:00:00 -0500https://capra.ca/en/blog/validation-rules-for-regulatory-transactions-submitted-in-the-electronic-common-technical-document-ectd-format-2018-02-20.htmhttps://capra.ca/en/blog/health-canadas-guidance-on-applications-for-medical-device-investigational-testing-authorizations-2018-02-05.htmIn late 2017, Health Canada released a draft guidance document to assist sponsors, manufacturers, and importers on the authorization process for investigational testing of medical devices. The draft guidance, titled “Applications for Medical Device Investigational Testing Authorizations”, is open for consultation and supersedes the previous guidance document from 1999 (“Preparation of an Application for Investigational Testing – Medical Devices”).Mon, 05 Feb 2018 00:00:00 -0500https://capra.ca/en/blog/health-canadas-guidance-on-applications-for-medical-device-investigational-testing-authorizations-2018-02-05.htmhttps://capra.ca/en/blog/guidance-document-guidance-for-manufacturers-of-human-immunodeficiency-virus-hiv-rapid-diagnostic-tests-rdts-for-use-at-the-point-of-care-or-for-self-testing-2018-01-29.htmIn late 2017, Health Canada published a new guidance document concerning HIV RDTs, titled “Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing” (the “Guidance Documents”). The Guidance Document provides manufacturers of Class IV HIV RDTs for point of care or self-testing applications with specific guidance on the analytical and clinical data as well as labelling considerations as part of the device application process.Mon, 29 Jan 2018 00:00:00 -0500https://capra.ca/en/blog/guidance-document-guidance-for-manufacturers-of-human-immunodeficiency-virus-hiv-rapid-diagnostic-tests-rdts-for-use-at-the-point-of-care-or-for-self-testing-2018-01-29.htmhttps://capra.ca/en/blog/health-canadas-notice-on-the-medical-device-single-audit-program-2018-01-22.htmLate last year, Health Canada issued a notice to the industry on the reduction of audit times for the Medical Device Single Audit Program (“MDSAP”).Mon, 22 Jan 2018 00:00:00 -0500https://capra.ca/en/blog/health-canadas-notice-on-the-medical-device-single-audit-program-2018-01-22.htmhttps://capra.ca/en/blog/the-acss-australia-canada-singapore-switzerland-consortium-and-the-generic-medicines-work-sharing-trial-2018-01-08.htmLast month the ACSS Consortium announced the launch of the Generic Medicines Work Sharing Trial, an innovative work sharing model for the coordinated assessment of applications for generic medicines.Mon, 08 Jan 2018 00:00:00 -0500https://capra.ca/en/blog/the-acss-australia-canada-singapore-switzerland-consortium-and-the-generic-medicines-work-sharing-trial-2018-01-08.htmhttps://capra.ca/en/blog/ich-publishes-new-guidance-on-pediatric-clinical-trials-and-genomic-data-2017-12-21.htmThe ICH has published and adopted two new guidance documents relating to drug development.Thu, 21 Dec 2017 00:00:00 -0500https://capra.ca/en/blog/ich-publishes-new-guidance-on-pediatric-clinical-trials-and-genomic-data-2017-12-21.htmhttps://capra.ca/en/blog/health-canadas-proposed-cannabis-regulatory-framework-2017-12-11.htmBill C-45, the proposed Cannabis Act (the “Act”), was introduced earlier in 2017 and is scheduled to be in force by July 2018. The Act will provide restricted access to cannabis for recreational purposes, as well as regulate its production, importation, exportation, distribution, sale, and possession.Mon, 11 Dec 2017 00:00:00 -0500https://capra.ca/en/blog/health-canadas-proposed-cannabis-regulatory-framework-2017-12-11.htmhttps://capra.ca/en/blog/new-guidance-document-use-of-a-foreign-sourced-reference-product-as-a-canadian-reference-product-2017-12-04.htmOn November 24, 2017 Health Canada published the Guidance Document “Use of a Foreign-sourced Reference Product as a Canadian Reference Product”, for sponsors who are seeking to demonstrate pharmaceutical equivalence and bioequivalence with a Canadian Reference Drug under paragraph (c) of C.08.001.1 of the Food and Drug Regulations. The Guidance Document replaces previous guidance which had been in place since 1995.Mon, 04 Dec 2017 00:00:00 -0500https://capra.ca/en/blog/new-guidance-document-use-of-a-foreign-sourced-reference-product-as-a-canadian-reference-product-2017-12-04.htmhttps://capra.ca/en/blog/toward-a-strengthened-assisted-human-reproduction-act-2017-11-27.htmThe increase in infertility in Canada has seen many Canadians turn to assisted human reproductive technologies to assist with family planning.Mon, 27 Nov 2017 00:00:00 -0500https://capra.ca/en/blog/toward-a-strengthened-assisted-human-reproduction-act-2017-11-27.htmhttps://capra.ca/en/blog/guidance-document-quality-chemistry-and-manufacturing-guidance-new-drug-submissions-ndss-and-abbreviated-new-drug-submissions-andss-2017-11-20.htmOn October 30, 2017, Health Canada released the final version of the Guidance Document - Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (“NDS”) and Abbreviated Drug Submissions (“ANDS”)Mon, 20 Nov 2017 00:00:00 -0500https://capra.ca/en/blog/guidance-document-quality-chemistry-and-manufacturing-guidance-new-drug-submissions-ndss-and-abbreviated-new-drug-submissions-andss-2017-11-20.htmhttps://capra.ca/en/blog/proposed-amendments-to-the-patented-medicines-regulations-2017-11-13.htmA significant portion of all healthcare-related expenditures in Canada is attributed to prescription drugs. Despite this, prescription drug costs have continued to rise, with Canada having some of the world’s highest prices for prescription drugs.Mon, 13 Nov 2017 00:00:00 -0500https://capra.ca/en/blog/proposed-amendments-to-the-patented-medicines-regulations-2017-11-13.htmhttps://capra.ca/en/blog/certificate-of-supplementary-protection-for-pharmaceuticals-biologics-and-veterinary-drugs-2017-11-06.htmHealth Canada has released the Guidance Document - Certificate of Supplementary Protection Regulations which provides information for industry regarding the recently implemented Certificates of Supplementary for medicinal ingredients.Mon, 06 Nov 2017 00:00:00 -0500https://capra.ca/en/blog/certificate-of-supplementary-protection-for-pharmaceuticals-biologics-and-veterinary-drugs-2017-11-06.htmhttps://capra.ca/en/blog/health-canadas-guidance-on-fees-for-review-of-submissions-2017-10-30.htmHealth Canada's guidance document on the Fees for the Review of Drug Submissions and Applications provides sponsors information concerning the fees associated with the review of submissions.Mon, 30 Oct 2017 00:00:00 -0400https://capra.ca/en/blog/health-canadas-guidance-on-fees-for-review-of-submissions-2017-10-30.htmhttps://capra.ca/en/blog/patented-medicines-notice-of-compliance-regulations-due-to-comprehensive-economic-and-trade-agreement-ceta-2017-10-23.htmHealth Canada recently published the Notice - Patented Medicines Notice of Compliance Regulations as an update for the public regarding the recently implemented amendments to the Patented Medicines (Notice of Compliance) Regulations which came into effect on September 21, 2017 as part of Canada’s obligations under the Comprehensive Economic Trade Agreement with the European Union. Mon, 23 Oct 2017 00:00:00 -0400https://capra.ca/en/blog/patented-medicines-notice-of-compliance-regulations-due-to-comprehensive-economic-and-trade-agreement-ceta-2017-10-23.htmhttps://capra.ca/en/blog/fda-regulatory-reform-2017-10-16.htmOn September 8th, 2017, the Food and Drug Administration signaled the start of a major regulatory overhaul by publishing a docket in the Federal Register (the “Docket”) requesting input from interested parties regarding unnecessary regulatory burdensMon, 16 Oct 2017 00:00:00 -0400https://capra.ca/en/blog/fda-regulatory-reform-2017-10-16.htmhttps://capra.ca/en/blog/ontario-to-require-public-disclosure-of-industry-payments-to-health-care-professionals-2017-10-10.htmOn September 27, 2017, the Government of Ontario tabled a bill to enact the Health Sector Payment Transparency Act, 2017, (the “Act”) which will implement reporting of transfers of value from the pharmaceutical and medical device industries to prescribed recipients.Tue, 10 Oct 2017 00:00:00 -0400https://capra.ca/en/blog/ontario-to-require-public-disclosure-of-industry-payments-to-health-care-professionals-2017-10-10.htmhttps://capra.ca/en/blog/first-nations-health-authority-fnha-transition-to-bc-pharmacare-2017-10-02.htmBeginning October 1, 2017, the FNHA will partner with BC PharmaCare to administer the FNHA PharmCare plan - a fully paid drug benefits plan for FNHA clients.Mon, 02 Oct 2017 00:00:00 -0400https://capra.ca/en/blog/first-nations-health-authority-fnha-transition-to-bc-pharmacare-2017-10-02.htmhttps://capra.ca/en/blog/new-health-canada-consultation-on-low-dose-codeine-products-2017-09-25.htmOn September 9th 2017, Health Canada released a notice in Canada Gazette Part I concerning the non-prescription availability of low-dose codeine productsMon, 25 Sep 2017 00:00:00 -0400https://capra.ca/en/blog/new-health-canada-consultation-on-low-dose-codeine-products-2017-09-25.htmhttps://capra.ca/en/blog/health-canadas-proposed-modification-for-multiphasic-modified-release-drugs-2017-09-18.htmThe guidance on Comparative Bioavailability Standards: Formulations Used for Systemic Effects provides sponsors with standards and parameters to consider for pharmacodynamics studies and comparative bioavailability studies against the reference product.Mon, 18 Sep 2017 00:00:00 -0400https://capra.ca/en/blog/health-canadas-proposed-modification-for-multiphasic-modified-release-drugs-2017-09-18.htmhttps://capra.ca/en/blog/health-canada-use-of-certificates-of-suitability-as-supporting-information-in-drug-submissions-2017-09-11.htmCertificates of Suitability (CEPs), issued by the European Directorate of Quality of Medicines and Healthcare (EDQM), are used to support the safety and efficacy of drugs. In the Health Canada guidance on Use of Certificates of Suitability as Supporting Information in Drug Submissions, CEPs can be submitted by applicants/sponsors in place of complete manufacturing information or the restricted portion of a Type 1 Active Substance Master File (ASMF)1.Mon, 11 Sep 2017 00:00:00 -0400https://capra.ca/en/blog/health-canada-use-of-certificates-of-suitability-as-supporting-information-in-drug-submissions-2017-09-11.htmhttps://capra.ca/en/blog/changes-to-the-manufacturers-name-andor-product-name-2017-09-05.htmThe Policy on Changes in Manufacturer’s name and/or Product Name (CMPN) applies to drug submissions to Health Canada where the manufacturer's and/or product’s name is being changed due to a merger, corporate restructuring, licensing agreement, or a buy-out. According to this Health Canada Policy, a licensing agreement is defined as “an agreement between two firms whereby one firm supplies a drug product to another firm for sale under the second firm’s name”.Tue, 05 Sep 2017 00:00:00 -0400https://capra.ca/en/blog/changes-to-the-manufacturers-name-andor-product-name-2017-09-05.htmhttps://capra.ca/en/blog/comprehensive-economic-and-trade-agreement-ceta-and-canadas-pharmaceutical-sector-2017-08-28.htmOn October 30th, 2016, Prime Minister Justin Trudeau, European Commission President Jean-Claude Juncker and European Council President Donald Tusk signed the Comprehensive Economic and Trade Agreement (CETA) during the European Union-Canada Leaders’ Summit in Brussels, Belgium.Mon, 28 Aug 2017 00:00:00 -0400https://capra.ca/en/blog/comprehensive-economic-and-trade-agreement-ceta-and-canadas-pharmaceutical-sector-2017-08-28.htmhttps://capra.ca/en/blog/changes-to-the-annual-drug-notification-form-adnf-2017-08-21.htmOn March 14, 2017, Health Canada published a notice outlining upcoming changes to the Annual Drug Notification Form.Mon, 21 Aug 2017 00:00:00 -0400https://capra.ca/en/blog/changes-to-the-annual-drug-notification-form-adnf-2017-08-21.htmhttps://capra.ca/en/blog/planning-to-file-your-505b2-product-in-canada-2017-08-15.htmCanada may not be top of the list of countries that companies target for first registration of their product (although it may be for orphan drugs – however, that’s a subject for another day!), but it’s usually in the next tier after USA and Europe, since typically Canada represents about 10% of the market size of the USA.Tue, 15 Aug 2017 00:00:00 -0400https://capra.ca/en/blog/planning-to-file-your-505b2-product-in-canada-2017-08-15.htmhttps://capra.ca/en/blog/summary-on-recent-intellectual-property-hold-for-notifiable-change-submissions-2017-08-07.htmOn April 7th, 2017, Health Canada released the Intellectual Property Hold for Notifiable Change Submissions notice. This notice is geared towards subsequent entry manufacturers and sponsors as per the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations.Mon, 07 Aug 2017 00:00:00 -0400https://capra.ca/en/blog/summary-on-recent-intellectual-property-hold-for-notifiable-change-submissions-2017-08-07.htmhttps://capra.ca/en/blog/an-update-on-the-regulatory-progress-of-biosimilars-in-canada-the-eu-and-the-us-2017-07-31.htmIn the last 10 years, biosimilar regulatory guidelines have evolved significantly in Canada, the European Union (EU) and the United States of America (U.S.). Anchored on the patent expiration date, there is a wave of biosimilars development in Western countries as well as other countries – all demanding cheaper versions of biologic medicines for their citizens.Mon, 31 Jul 2017 00:00:00 -0400https://capra.ca/en/blog/an-update-on-the-regulatory-progress-of-biosimilars-in-canada-the-eu-and-the-us-2017-07-31.htmhttps://capra.ca/en/blog/plain-language-labelling-summary-2017-07-24.htmA few years ago on June 13th, 2015, the Plain Language Labelling Regulations became effective for prescription drugs in Canada.Mon, 24 Jul 2017 00:00:00 -0400https://capra.ca/en/blog/plain-language-labelling-summary-2017-07-24.htmhttps://capra.ca/en/blog/health-canada-begins-consultations-on-mandatory-reporting-by-health-care-institutions-2017-07-17.htmHealth Canada has commenced consultations on proposed changes to the Food and Drug Regulations and Medical Devices Regulations that would require mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions.Mon, 17 Jul 2017 00:00:00 -0400https://capra.ca/en/blog/health-canada-begins-consultations-on-mandatory-reporting-by-health-care-institutions-2017-07-17.htmhttps://capra.ca/en/blog/patients-and-philanderers-why-the-ashley-madison-report-has-something-important-to-say-about-cybersecurity-standards-for-patient-data-2017-07-10.htmPrivacy legislation in Canada, the U.S. and elsewhere, while imposing detailed requirements on issues such as consent, often reverts to high level principles in outlining privacy safeguards or security obligations.Mon, 10 Jul 2017 00:00:00 -0400https://capra.ca/en/blog/patients-and-philanderers-why-the-ashley-madison-report-has-something-important-to-say-about-cybersecurity-standards-for-patient-data-2017-07-10.htmhttps://capra.ca/en/blog/ich-good-clinical-practice-renovation-2017-07-05.htmOn January 2017, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a reflection paper titled Good Clinical Practice Renovation: Modernization of ICH E8 and Subsequent Renovation of ICH E6. The reflection paper discusses current issues with the ICH guidelines regarding clinical trial design and conduct, and the need to update the guidelines to reflect current concerns.Wed, 05 Jul 2017 00:00:00 -0400https://capra.ca/en/blog/ich-good-clinical-practice-renovation-2017-07-05.htmhttps://capra.ca/en/blog/canadian-drug-establishment-licences-gmp-requirements-for-api-foreign-building-2017-06-26.htmCanada's Food and Drug Regulations (FDR) were amended to extend the requirements of Division 1A - Establishment Licensing and Division 2 - Good Manufacturing Practices (GMP) to active ingredients used in pharmaceutical drugs for human use only.Mon, 26 Jun 2017 00:00:00 -0400https://capra.ca/en/blog/canadian-drug-establishment-licences-gmp-requirements-for-api-foreign-building-2017-06-26.htmhttps://capra.ca/en/blog/a-recap-on-vanessas-law-2017-06-19.htmWith the evolution of healthcare products and its regulations, today we will recap one of the most significant recent changes in Canadian regulations; Vanessa’s Law.Mon, 19 Jun 2017 00:00:00 -0400https://capra.ca/en/blog/a-recap-on-vanessas-law-2017-06-19.htmhttps://capra.ca/en/blog/changes-to-the-annual-renewal-process-of-canadian-drug-establishment-licences-2017-06-12.htmEffective 2017 Annual Licence Renewal (ALR) of Drug Establishment Licences (DEL), Health Canada has added an extra step to the ALR submission process by DEL holders. This change constitutes of an addition of a MS Excel sheet known as “Product List” and it has been provided to all the DEL holders along with the 2017 ALRs packages.Mon, 12 Jun 2017 00:00:00 -0400https://capra.ca/en/blog/changes-to-the-annual-renewal-process-of-canadian-drug-establishment-licences-2017-06-12.htmhttps://capra.ca/en/blog/fdas-ectd-mandate-are-you-ready-2017-06-05.htmWhen FDA posted their eCTD mandate last year, it was more of a whisper than a bang. It certainly did not wreak havoc in the industry; after all, we were all warned that the time would come sooner rather than later.Mon, 05 Jun 2017 00:00:00 -0400https://capra.ca/en/blog/fdas-ectd-mandate-are-you-ready-2017-06-05.htmhttps://capra.ca/en/blog/information-on-the-new-access-to-cannabis-for-medical-purposes-regulations-2017-05-29.htmOn August 11, 2016, Health Canada announced the new Access to Cannabis for Medical Purposes Regulations (ACMPR) which came into force on August 24, 2016Mon, 29 May 2017 00:00:00 -0400https://capra.ca/en/blog/information-on-the-new-access-to-cannabis-for-medical-purposes-regulations-2017-05-29.htmhttps://capra.ca/en/blog/annual-drug-notification-form-2017-05-23.htmThe Annual Drug Notification Form (ADNF) is intended to assist manufacturers in complying with section C.01.014.5 of the Food and Drug Regulations which requires that every manufacturer of a drug confirms annually before October that all information previously supplied with regard to that drug is correctTue, 23 May 2017 00:00:00 -0400https://capra.ca/en/blog/annual-drug-notification-form-2017-05-23.htmhttps://capra.ca/en/blog/future-regulatory-initiative-for-opioids-2017-05-15.htmOpioids are narcotic pain relieving medications and are commonly prescribed in North America for acute and chronic pain. However, in addition to its therapeutic effects, opioids carry various side effects including increasing tolerance and the potential for dependence and overdose, which can be fatal.Mon, 15 May 2017 00:00:00 -0400https://capra.ca/en/blog/future-regulatory-initiative-for-opioids-2017-05-15.htmhttps://capra.ca/en/blog/changes-to-submission-filing-requirements-good-manufacturing-practices-gmpdrug-establishment-licences-del-2017-05-08.htmHealth Canada on February 10, 2017 has issued a notice outlining changes to the submission filing requirements pertaining to Good Manufacturing Practices (GMP)/ Drug Establishment Licences (DEL). These changes are effective immediately for drug submissions filed after the date of this notice (February 10, 2017).Mon, 08 May 2017 00:00:00 -0400https://capra.ca/en/blog/changes-to-submission-filing-requirements-good-manufacturing-practices-gmpdrug-establishment-licences-del-2017-05-08.htmhttps://capra.ca/en/blog/the-journey-towards-safe-food-for-canadians-2017-05-01.htmWith alarming food safety recalls across the nation, in January 21st 2017, the long-awaited proposed regulations under the Safe Food for Canadians Act (SFCA), which received Royal Assent on November 22nd, 2012, was published in Canada Gazette I.Mon, 01 May 2017 00:00:00 -0400https://capra.ca/en/blog/the-journey-towards-safe-food-for-canadians-2017-05-01.htmhttps://capra.ca/en/blog/natural-health-product-research-society-nhprs-of-canada-hosts-14th-annual-conference-beyond-tradition-2017-04-25.htmThe Natural Health Product Research Society (NHPRS) of Canada is pleased to host its 14th annual conference, Beyond Tradition, May 8-11, 2017Tue, 25 Apr 2017 00:00:00 -0400https://capra.ca/en/blog/natural-health-product-research-society-nhprs-of-canada-hosts-14th-annual-conference-beyond-tradition-2017-04-25.htmhttps://capra.ca/en/blog/confidential-business-information-disclosure-update-2017-04-17.htmThe Health Minister can disclose confidential business information (CBI) to protect or promote health or safety. A draft guidance document on the disclosure of CBI was published on Mar 10, 2016 and Health Canada underwent a consultation period.Mon, 17 Apr 2017 00:00:00 -0400https://capra.ca/en/blog/confidential-business-information-disclosure-update-2017-04-17.htmhttps://capra.ca/en/blog/changes-to-the-foreign-site-expiry-dates-on-canadian-drug-establishment-licences-2017-04-10.htmEffective July 21, 2016, Health Canada has changed the expiry date for foreign building GMP renewal evidence to a NERBY (New Evidence Required By) date.Mon, 10 Apr 2017 00:00:00 -0400https://capra.ca/en/blog/changes-to-the-foreign-site-expiry-dates-on-canadian-drug-establishment-licences-2017-04-10.htmhttps://capra.ca/en/blog/welcome-to-regulated-affairs-2017-04-03.htmWe are excited to be launching a blog for The Canadian Association of Professionals in Regulatory Affairs (CAPRA)! Your source for timely information on news, events and updates in regulatory affairs in Canada.Mon, 03 Apr 2017 00:00:00 -0400https://capra.ca/en/blog/welcome-to-regulated-affairs-2017-04-03.htmhttps://capra.ca/en/blog/validation-rules-for-regulatory-transactions-submitted-in-the-electronic-common-technical-document-ectd-format-1970-01-01.htmLate last year, Health Canada announced the revised validation rules for regulatory transactions in the electronic Common Technical Document (“eCTD”) format.Wed, 31 Dec 1969 19:00:00 -0500https://capra.ca/en/blog/validation-rules-for-regulatory-transactions-submitted-in-the-electronic-common-technical-document-ectd-format-1970-01-01.htm