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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...
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...
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...
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...