Emergency Drug Release Program

To improve access to unauthorized human drugs and veterinary drugs, proposed regulations have been published

Proposed amendments have been published by the government of Canada to the Food and Drug Regulations (Regulations) which will result in the improvement of access to the unlicensed human drugs via the Special Access Program and unlicensed veterinary drugs via the Emergency Drug Release Program.

Insights:

  • Yet the proposed regulations aren’t a law. Until 12th July comments might be provided by the stakeholders on the proposed regulations. Public consultations by Health Canada on a draft guidance document have been opened regarding the proposed regulations, and the comments will be accepted on the document until 19th of July.
  • The purpose of the purposed regulations is to make the requests of the practitioners easy which make by means of the Special Access Program or the Emergency Drug Release Program. For example, patients won’t be needing the identification in the request anymore. In addition to this, in certain circumstances, practitioners will be enabled leverage of:
  1. i) Approvals which have been obtained in the European Union or the US
  2. ii) An earlier authorization under the Special Access Program or the Emergency Drug Release Program.
  • Manufacturers of the drug will be enabled to pre-position a drug in Canada, which will assist in the avoidance of any delays attached to the importing of the drug.
  • There will also be an amendment of the authorization of Supplementary Protection Regulations for the clarification that sale of a drug under the Special Access Program or the Emergency Drug Release Program will not hinder the ability of the manufacturer in obtaining the patent term extension with relation to that drug.
  • The proposed Regulations are favoring innovation and development. In addition to this, they will apply to the requests which are made by means of the Special Access Program or the Emergency Drug Release Program after the date when the proposed Regulations will come into force.
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