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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...
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
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...
How Health Canada's ‘Draft Guidance on Electronic Media in Prescription Drug Labelling’ May Affect Drug Advertising
Health Canada (HC) launched a consultation on the 'DRAFT Guidance for Electronic Media in Prescription Drug Labelling' on March 12, 2021 and will close it to new input on...
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....