On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. The proposed amendments: 1) authorize the Minister of Health (the Minister) to impose terms and conditions on drug and medical device authorizations and to require a Risk Management Plan (RMP); 2) extend flexibilities currently in use for COVID-19 drugs to … Continue Reading
As we have previously reported, the Minister of Health (Minister) approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order for Drugs and Vaccines) on September 16, 2020 and the Interim order respecting the importation and sale of medical devices for use in relation to COVID-19 (Interim Order for Medical Devices) on March 18, 2020.
Both interim orders are set to expire 1 year after they were issued, or sooner if withdrawn by the Minister. Any authorization for drugs, vaccines, and medical devices issued … Continue Reading
Health Canada has finalized amendments to the Food and Drug Regulations (FDR) and Natural Health Product Regulations (NHPR) to allow for the distribution of samples of non-prescription drugs (NPDs, or “over-the-counter” (OTC) drugs) and natural health products (NHPs) to a larger scope of healthcare professionals as well as the general public. Previously, the distribution of these products was limited to physicians, dentists, veterinary surgeons and pharmacists. The regulatory amendments were made as part of Canada’s obligations under the Canada–United States–Mexico Agreement (CUSMA) and the passing of the CUSMA … Continue Reading
On April 22, 2017, the Government of Canada published draft regulations Amending the Food and Drug Regulations (Vanessa’s Law) that provide details regarding the minister of health’s powers to require tests, assessments and studies of a drug post-market authorization. The draft regulations also set out additional reporting requirements for manufacturers based on the actions of foreign regulators.
Stakeholders can make representations concerning the draft regulations until June 27, 2017.
On November 6, 2014, the Protecting Canadians from Unsafe Drugs Act (also known as Vanessa’s Law) came into force and amended the Food and Drugs Act. The amendments … Continue Reading
Health Canada has proposed regulations that will amend the Food and Drug Regulations to allow for importation of drugs that have not yet received regulatory approval from Health Canada. The new regulations will provide access to drugs that address an urgent public health need provided they have been approved in the United States, the European Union, or Switzerland. “Urgent public health need” is not a defined term in the regulations, but Health Canada identified treatment of opioid use disorder as a current example of an urgent need.
This scheme does not replace existing programs that provide access to drugs that … Continue Reading