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Full Implementation of Health Canada’s API Program Begins November 8th

Posted November 02, 2016

Several years ago, Canada's Food and Drug Regulations were amended to extend the requirements pertaining to establishment licensing and “Good Manufacturing Practices” (GMP) to active ingredients used in pharmaceutical drugs for human use.

The amended Regulations came into force on November 8, 2013 and were slated to be put into effect over a three-year period. In accordance with this timeline, November 8, 2016 will mark the full implementation of the Active Pharmaceutical Ingredients (API) program.

To facilitate achievement of full implementation, Health Canada has issued a notice to stakeholders communicating the following information:

  • Updated Table A and instructions for new and amending drug establishment licence (DEL) applications related to importing drugs, including APIs.
  • Updated information about the good manufacturing practice (GMP) evidence required by Health Canada to demonstrate GMP compliance of API foreign buildings.

The Health Canada notice applies to the following entities conducting activities related to active pharmaceutical ingredients (API) in Canada:

  • API importers
  • Finished dosage form (FDF) fabricators who import APIs for use in manufacturing
  • FDF importers

As of November 8, 2016, importers will be expected to have satisfactory GMP compliance evidence as outlined in Part B, Sections A.1 (inspections by Health Canada) and A.2.i (inspections by recognized regulatory authorities and organizations) of the notice.

Consultant or corporate audits should not be used as GMP evidence for buildings conducting activities related to APIs used in the manufacture of drugs listed on the Prescription Drug List.

Depending on the nature and risk profile of the products, for example APIs used in manufacture of over-the-counter drugs, Health Canada may consider evidence as noted in Part B, Section A.2.ii (consultant or corporate audits). Inspection reports or certificates issued by regulatory authorities or organizations indicated in Part B, Section A.2.iii may be considered as supplementary information to complement the GMP evidence indicated.

Alternatively, importers may ask Health Canada to conduct an inspection. For more information on requesting inspections by Health Canada, please see Section of the Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).