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Digital Therapeutics - Reshaping the future of medicine

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...

The Need for Regulatory Innovation in Canada: A Series (Issue 1)

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

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...

Biosimilars and their Approval in Canada

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

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for Reporting the Amount for calendar year 2020 In October 2021, the Food and Drug Administration (FDA) issued a Draft Guidance for...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

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

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...

Health Canada-MHRA Guideline: Increasing Transparency When Presenting Safety Information in the DSUR

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

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

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)

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...

How Health Canada's ‘Draft Guidance on Electronic Media in Prescription Drug Labelling’ May Affect Drug Advertising

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...