Active Pharmaceutical Ingredient (API) Registration in Canada

An active pharmaceutical ingredient (API) is an active ingredient or raw material used in the fabrication of a pharmaceutical drug dosage form. API quality directly impacts the safety and efficacy of the finished pharmaceutical dosage form. Poorly manufactured and contaminated active ingredients have been associated with negative health outcomes, including death, in a number of incidents over the past decades.  For this reason, most countries around the world are now regulating active ingredients.

Fabrication, packaging/labelling, testing and importation of APIs are licensable activities requiring the submission of a drug establishment license application (DEL). All foreign buildings conducting licensable activities with regards to APIs imported into Canada and/or for all APIs used in the fabrication, packaging/labelling, and/or testing of finished dosage forms in a foreign country intended for import into Canada are to be included in a DEL application or amendment. Domestic API information such as API activities and API product details for APIs fabricated, packaged and labeled in Canada are also included.

The licensable activities above, along with non-licensable distribution and wholesale are also subject to compliance with Good Manufacturing Practices (GMP) regulations in Canada, which came into force on November 08, 2013. Tables 1 and 2 (Appendix) provide an overview of GMP requirements for APIs throughout the manufacturing supply chain. GMP compliance is achieved through the establishment and maintenance of a quality management system (QMS) that comprises of premises, people, processes, controls and documentation as shown in the GMP sections of Table 1. Health Canada will take a risk based inspection approach to assure quality compliance. GMP evidence would need to be presented to Health Canada on request within 48 hours.

At AXSource Consulting, we support Canadian and foreign API fabricators, packagers, labelers, importers, testers, distributors and wholesalers with all their compliance needs. Our consultants will successfully take you through the DEL application process, establishing robust quality management systems that achieve compliance ratings at Health Canada inspections.

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