Health Canada issued a notice to industry and is advising that on November 8, 2016, full implementation of the active pharmaceutical ingredients (API) program will begin.
To facilitate achievement of full implementation, Health Canada is communicating the following information to the industry:
- 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.
This notice applies to the following establishments (persons) 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 this 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.iiimay 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 3.2.1.1 of the Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
Contact Information
Any questions or comments regarding GMP evidence, email:
API_questions_IPA@hc-sc.gc.ca.