Regulatory amendments to the Food and Drug Regulations (FDR) and the Natural Health Products Regulations (NHPR) were published in Canada Gazette (Part II) on October 14, 2020. We previously reported on these changes, which seek to reduce the administrative burden associated with the Special Access Program (SAP) (for human drugs) and the Emergency Drug Release (EDR) (for drugs for veterinary use).
To recap, previously a practitioner requesting a drug under the SAP was required to submit supporting data concerning the use, safety, and efficacy of the drug with each request. This supporting documentation is no longer required if:
- the drug has been previously authorized by the SAP for the same medical emergency;
- the drug is authorized for sale without terms and conditions (e., without any further restrictions placed on the drug) by the European Medicines Agency or the United States Food and Drug Administration for the same medical emergency for which the drug is requested; and
- any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.
The new regulations also permit “pre-positioning” of a drug in Canada by manufacturers in advance of a request for the drug by a practitioner and authorization by the SAP or the EDR program. Through these provisions, a manufacturer will be able to submit a request for a letter of authorization allowing for the importation of a given drug by a Canadian drug establishment licence (DEL) holder. The DEL holder is prohibited from distributing the drug to a practitioner until a letter of authorization has been issued by the SAP or EDR program. The DEL holder will also need to ensure that there is a system of control in place to allow a rapid recall of the drug.
Additional changes include:
- allowing an SAP or EDR request to be made when the patient’s identity (human or animal) is not known (to permit, for example, future-use situations, where a drug is needed for administration in an emergency by a first responder or in the hospital and the patient’s identity is unknown);
- allowing drugs to be shipped to community pharmacies or other practitioners, rather than pre-specifying in the request the names of all institutions which might receive the SAP or EDR drug; and
- expanding the antimicrobial reporting requirement to veterinary drugs approved under the EDR (which where previously exempt).
Health Canada has also published a final guidance document detailing the process for a practitioner to request a drug under the SAP, as well as the process for manufacturers who wish to file a request for pre-positioning.
We also reported that the initial amendments contained proposed changes to the FDR to facilitate access to drugs to be used by a public health official to address a public or military health emergency, event or incident. Revisions to this element of the proposal are ongoing. Therefore, the project related to the proposed Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) will proceed separately.