Regulatory amendments to the Food and Drug Regulations and Natural Health Products Regulations were published in Canada Gazette (Part II) on October 14. These amendments seek to reduce the administrative burden associated with Emergency Drug Release (EDR) program.
The EDR program for veterinary drugs receives between 600 and 1,000 requests per year. Drugs are accessed by veterinarians through the EDR program to treat diseases in many species, including companion animals, food-producing animals, wildlife species and fish. An average of 45 drugs have an active status in the program. To request access to drugs through the EDR program, practitioners submit a request to Health Canada for a drug that is otherwise unauthorized for sale in Canada to treat a patient.
Practitioners are responsible for ensuring the decision to prescribe the drug is supported by credible evidence. They are also responsible for monitoring and reporting the results of the drug's use, including any adverse drug reactions. Once the drug's use is approved by Health Canada, a letter of authorization is sent from EDR program to the drug manufacturer, authorizing the sale of a quantity of the drug to a named practitioner.
The revised regulations help to streamline the process in a number of ways. Previously a practitioner requesting a drug under the EDR 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 EDR for the same medical emergency;
- the drug is authorized for sale without terms and conditions (i.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 before a request for the drug by a practitioner and authorization by the EDR program. Through these provisions, a manufacturer will be able to submit a request for a letter of authorization allowing 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 there is a system of control in place to allow a rapid recall of the drug.
Finally, veterinary drugs accessed under the EDR program previously were exempt from the antimicrobial reporting requirements under the Food and Drug Regulations. These reporting requirements, in place since 2017, require manufacturers, importers and compounders of drugs for veterinary use that contain an active pharmaceutical ingredient on the List of Certain Antimicrobial Active Pharmaceutical Ingredients (List A) to provide an annual report for each drug that lists the total quantity sold and an estimate of the quantity sold for each intended animal species. Drugs accessed under the EDR program were previously exempt from these requirements. As part of the current amendments, Health Canada is expanding the antimicrobial reporting requirement to veterinary drugs authorized under the emergency provisions by the EDR program.
For an update on similar changes to the Special Access Program for human drugs, see our Pharma in Brief article here.
Originally published by Norton Rose Fulbright, November 2020
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