Welcome to the CAPRA Blog
Rethinking Cost-Sharing: The Need for Health Insurance Reform in the U.S.
In the U.S., the system designed to protect Americans from the financial devastation of illness often ends up being the very source of that devastation. While it can be...
Value-Based Drug Pricing in Canada and its Limitations
Drug pricing is a complex and controversial issue that often sparks debates among patients, pharmaceutical companies, and the government. Prices can vary significantly...
Addressing Underrepresentation in Clinical Trials: FDA's Diversity Action Plan
The U.S. Food and Drug Administration (FDA) released a new draft guidance in June 2024 to enhance the diversity of clinical trial participants. The guidance details the...
VIRTUAL HEALTHCARE IN CANADA
“Virtual care” is defined as any “interaction between patients and/or members of their circle of care, occurring remotely, using any forms of communication or information...
Artificial Intelligence – Revolutionizing the Healthcare Industry
What is Artificial Intelligence? Artificial intelligence (AI) is a broad term for a category of algorithms and models that perform tasks and exhibit behaviors such as...
Technology Continues to Transform Healthcare and the Regulatory World
Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more...
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...
Health Canada changes filing requirements for product monographs
Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs? This is for only post-life...
Pragmatic Clinical Trials: Testing Treatments in the Real-World
What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment has...
The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022
The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....
3D Printing Our Way To Better Health Care
What is 3D Printing? 3-Dimensional (3D) printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is...
Digital Therapeutics - Reshaping the future of medicine
Digital Therapeutics – Reshaping the future of medicine What is Digital Therapeutics? With healthcare becoming digital, patients today are more empowered than ever before. As...
The Need for Regulatory Innovation in Canada: A Series (Issue 1)
The Need for Regulatory Innovation in Canada: A Series (Issue 1) Healthcare innovation has a strong position in Canada. From Insulin to Pacemaker to Polio Vaccine, medical...
Real-World Data/Evidence – increasing use in Healthcare for Regulatory Decision Making
Real-World Data/Evidence – Increasing use in Healthcare for Regulatory Decision Making What is Real-World Evidence/Data? The availability of real world data (RWD) has been...
Biosimilars and their Approval in Canada
BIOSIMILARS AND THEIR APPROVAL IN CANADA Biosimilars are regulated as innovative pharmaceuticals in Canada under Food and Drugs Act and Part C of the Food and Drugs...
FDA’s New Annual Distribution Reporting Requirement under Section 510(j)(3) of the FD&C Act for Reporting the Amount of Commercially Distributed Listed Drugs and Biological Products
Due date (February 15, 2022) approaching for Reporting the Amount for calendar year 2020 In October 2021, the Food and Drug Administration (FDA) issued a Draft Guidance for...
To Distribute or Not to Distribute? Health Canada’s Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada
Further to Health Canada’s amendments to the Food and Drug Regulations (FDR) to make the provisions under the one-year Interim Order respecting drug shortages (safeguarding...
Health Canada Draft Revised Guidance Documents on Post-NOC Changes - Quality for Consultation
On August 6, 2021, Health Canada issued five draft revised Guidance Documents on Post-Notice of Compliance (NOC) Quality Changes for stakeholder consultation. The proposed...
Health Canada-MHRA Guideline: Increasing Transparency When Presenting Safety Information in the DSUR
On July 6, 2021, Health Canada and the Medicines and Healthcare products Regulatory Agency (MHRA) jointly published a Guideline on how to increase transparency when...
Health Canada’s Proposal for Clinical Trials Regulatory Modernization
On May 20, 2021 Health Canada opened a consultation on its proposal to modernize the regulatory framework for clinical trials related to human drugs, medical devices,...
Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19
In response to the ongoing need for innovative COVID-19 diagnosis, treatment, mitigation, or prevention options, Health Canada announced the approval of Interim Order No. 2...
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)
As the COVID-19 pandemic continues and its unprecedented challenges rapidly evolve, Health Canada’s (HC) agile regulatory measures, called Interim Orders, continue to play a...
How Health Canada's ‘Draft Guidance on Electronic Media in Prescription Drug Labelling’ May Affect Drug Advertising
Health Canada (HC) launched a consultation on the 'DRAFT Guidance for Electronic Media in Prescription Drug Labelling' on March 12, 2021 and will close it to new input on May...
Drug Reimbursement: Aligned Review Process by CADTH
In an effort to make Pharmaceutical Reviews program more cohesive, transparent, and responsive, on September 30, 2020, The Canadian Agency for Drugs and Technologies in...
Non-medical masks or face coverings: Regulatory considerations in the context of COVID-19
On July 24, 2020, Health Canada published a notice to industry that explains circumstances under which non-medical masks or face coverings would be subject to the regulatory...
Step 2b draft Q3C(R8): Impurities: Guideline for Residual solvents – Released for public consultation
The 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 drug substances and...
An update from NNHPD – Release of new web PLA form version 4
Author: Bhavesh Patel Quick Facts about Natural Health Products in Canada: Health Canada regulates natural health products (NHPs) so that Canadians can have confidence that...
Interim Order to facilitate COVID-19 Clinical Trials related to Drugs and Medical Device
Author: Preetha Prabhu On May 23, 2020, the Minister of Health signed an Interim Order (IO) Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19....
Interim Labelling of products during COVID-19: Hand sanitizers, disinfectants, soaps and cleaning products
Author: Preetha Prabhu According to Statistics Canada, demand for hand sanitizer increased by 735% for the week ending March 14, 2020, relative to the same period last year....
Distribution of low risk DIN/NPN products as samples
Author: Teri Dickinson , Manager, Regulatory Affairs, Dell Tech Laboratories Ltd. Beginning July 1, 2020 , industry will be able to distribute certain non-prescription drugs...