An amendment to the Food and Drug Regulations has been proposed that would extend the good manufacturing practices (GMP) requirements for drugs to all active ingredients (AI); extend drug establishment licensing requirements to those carrying out various activities involving AI; and create a new record-keeping requirement to facilitate the ability to trace AI from the original fabricator to the dosage-form drug manufacturer. The proposed amendment would allow Canada to establish regulatory equivalence for AI with other industrialized countries, especially those with which Canada has a Mutual Recognition Agreement.

AI are substances that, when used as a raw material in the fabrication of a drug in dosage form, provide the intended effect. The quality of the AI in a drug has a direct effect on the safety and efficacy of that drug, such that poorly manufactured and/or contaminated AI may be associated with negative health outcomes.

Under the proposed regulatory amendment, no person who has fabricated, packaged/labelled, tested or stored a drug would be permitted to sell the drug unless they have performed their activity in accordance with GMP requirements. Dosage-form fabricators would be required to use only GMP-compliant AI in their drugs. A Drug Identification Number-holding distributor or importer of a dosage-form drug would be prohibited from selling the drug unless it (including any AI contained therein) is GMP-compliant.

The proposed regulatory amendment would also extend establishment licensing requirements to all AI fabricators, packagers/labellers, testers and importers. An establishment licence would not issue until an applicant has been assessed by Health Canada and found to be in compliance with the proposed GMP requirements.

Every fabricator, packager/labeller, distributor, wholesaler and importer of an AI would be required to add the following information to the documentation that accompanies the AI: (a) the regulated party's name; contact details, and establishment licence number (if applicable); (b) whether it has fabricated, packaged/labelled, distributed, wholesaled or imported the drug; (c) the date of that activity; (d) the expiration or re-test date of the drug; and (e) the lot number of the drug. This record-keeping amendment is intended to allow for more rapid and targeted investigations and, if necessary, recalls of problematic AI.

Interested stakeholders have until December 13, 2012 to make representations concerning the proposed amendment.