Canada: GMP Requirements now Applicable to all APIs

The GMP requirements which have been applicable to medicinal products in Canada have now been extended to APIs which are used in human and veterinary medicinal products. This information was published on 8 May 2013 in a press release of Health Canada.

A modification of the Canadian GMP Guide had preceeded it. After the draft document "Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104)" had been published for comment on 22 October 2012 until 5 January 2013, the final version "Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices)" was released on 8 May 2013 in the "Canada Gazette" - Health Canada's official publication organ.

The main revisions in the regulations concern among other things licencing for production facilities, packagers/labellers, test laboratories and importers of APIs. New provisions on document and record retention periods have also been added.

The extended GMP requirements will apply 6 months after the publication in the Canada Gazette: on 8 November 2013. The industry stakeholders affected by the new regulation had already expressed their concerns regarding the short preparation delay within the consultation deadline. Transitional provisions have thus been included in the regulation (see "Regulations", chapter "Transitional Provisions"). According to them, facilities will be allowed to continue to manufacture without an establishment licence provided they submit an establishment licence application within three months after the coming into force of the Regulations, on 8 November.

With the official implementation of GMP requirements for APIs according to ICH Q7, Canada has taken the first step towards international harmonisation. Indeed, this is an important step with regard to the current discussion about "Written Confirmation" and the quality of APIs in global supply chains.