Notice to Stakeholders: Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs

May 10, 2019
Our file number: 19-103917-252

In 2017, Health Canada undertook the Regulatory Review of Drugs and Devices (R2D2) with the objective of developing an agile regulatory system that supports access to therapeutic products based on healthcare system needs. As part of the R2D2, Health Canada conducted a review of the Special Access Program (SAP) for human drugs and the regulatory authorities supporting the Program. The SAP for human drugs administers the medical emergency provisions of the Food and Drug Regulations. The Program considers requests for unauthorized drugs from health practitioners treating individual patients with serious or life-threatening conditions in cases where conventional therapies have failed, are unsuitable, or unavailable. The SAP is an important component of Health Canada’s regulatory system by allowing access to therapeutic products that are otherwise not available for use in a medical emergency. Each year, the SAP authorizes more than 16,000 requests from practitioners treating patients in medical emergencies.

On May 10, 2019, Health Canada pre-published in Canada Gazette, Part I, amendments to the Food and Drug Regulations (FDR) entitled “Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment)” for a 70-day stakeholder consultation period from May 10, 2019 until July 19, 2019. Through these amendments, Health Canada is proposing to improve the process for accessing drugs that have been previously authorized under the SAP. Practitioners would be exempt from submitting data on the use, safety and efficacy of the drug for the same medical emergency if certain conditions are met. The Department is further proposing to allow drug companies to bring certain drugs into Canadian facilities in advance of potential requests from practitioners for the drug. This would reduce the time it takes to ship the drug to health practitioners.

To accompany the proposed regulations, Health Canada is pleased to announce the release of the draft guidance document entitled: “Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs”. The draft guidance provides information on the interpretation of the proposed regulations and explains the request and authorization process and reporting requirements when requesting a drug for use in a medical emergency, and foreign drug manufacturers requesting to store a drug in a Canadian facility.

We are seeking stakeholder comments on the draft guidance document that is to be read in conjunction with the proposed regulations. The proposed regulations can be found on the Canada Gazette website.