Notice to stakeholders: Final guidance document for industry and practitioners on the Special Access Program (SAP) for drugs

October 14, 2020

The Therapeutic Products Directorate (TPD) has published the final guidance document for industry and practitioners on the Special Access Program (SAP) for drugs.

This document gives information on changes made to the Food and Drug Regulations. It was published on October 14, 2020, in Part II of the Canada Gazette. See Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment).

You can find information on:

• the request and authorization process
• the reporting requirements for drugs requested by:
  • health care practitioners for use in a medical emergency or
  • foreign manufacturers wishing to pre-position a drug in Canada in advance of a SAP drug request

The final guidance document also outlines how requests for special access to unauthorized drugs:

• are being managed
• comply with Part C, Division 8, sections C.08.010 and C.08.011 of the Food and Drug Regulations

Changes made to SAP are especially important and timely given the current COVID-19 pandemic. Health care practitioners have been using the program to request drugs to provide supportive treatments to COVID-19 patients. A more flexible and streamlined process due to changes made to the Regulations ensures they will be able to continue to do so.

Stakeholders were able to provide comments to TPD over a 70-day period after the draft document was published in May 2019. The proposed amendments also appeared in Part I of the Canada Gazette Part I.

You may direct any questions or comments about this final guidance document to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Holland Cross Tower B A/L 3102C5
1600 Scott Street
Ottawa ON K1A 0K9

Tel.: 613-948-4623
Email: hc.policy.bureau.enquiries.sc@canada.ca