Notice to stakeholders – Draft guidance document for consultation: Guide to Good Manufacturing Practice for Medicinal Products Annex 1: Manufacturing of sterile medicinal products

Current status: Open

Due to the challenges posed by COVID-19, the timeline for the second targeted consultation on the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products Annex 1 Manufacture of Sterile Medicinal Products has been extended until July 20, 2020.

Health Canada is pleased to release the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products Annex 1 Manufacture of Sterile Medicinal Products for a 5-month consultation period, from February 20, 2020 to July 20, 2020. 

This Annex has been updated after considering over 6200 stakeholder comments received from the December 20, 2017 to March 20, 2018 consultation. This second consultation is intended to focus on limited sections that were subject to changes of significance — see below.  

Once finalized, Health Canada’s intention is to adopt this Annex within Health Canada’s GUI-0119: Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs.  It will be published in both official languages and support compliance with good manufacturing practices and drug establishment licence requirements prescribed in Part C, Division 1A and Division 2 of the Food and Drug Regulations. 

This consultation document is only available in English since this is the operating language of PIC/S. It has been formatted with prescribed line and page numbers to support a joint international consultation within PIC/S, the World Health Organization (WHO) and the European Commission.  Health Canada is a PIC/S Participating Authority that is engaged in the joint international consultation and the drafting of the revisions to the Annex.

We encourage you to review the document and to send us your comments. Health Canada will assess all stakeholder comments received and consider them in developing a Canadian position prior to adopting this Annex. Comments received will be evaluated and complied by Health Canada before being transmitted to the joint international working group for consideration in drafting the final version of the document.


The consultation document was prepared in cooperation with the European Medicines Agency (EMA), WHO, and PIC/S in order to maintain global alignment of standards, all the while assuring the highest quality document possible. The document is subject to parallel public consultation by the European Commission, WHO and PIC/S.

As detailed in the European Commission consultation notice, stakeholders are encouraged to submit comments through one of the associations listed below. These associations representing relevant stakeholders have accepted to take part in this second consultation.  They agreed to receive comments from their members, to compile them and submit them to the joint international working group through the European Commission.

The scope of this consultation is intended to be focused on key changes that have occurred since the previous version.  Key changes from the earlier PIC/S Annex includes revisions due to stakeholder feedback on:

Other key changes introduced as a result of subsequent review include:

How to participate

1. Obtain documents

You are encouraged to engage in the consultation through one of the listed associations where possible. Alternatively, you can email to receive copies of the:

2. Submit comments

Please minimize duplication in the event that you have submitted feedback to this joint international consultation through an alternate means.

Submit your comment form to one of the above listed associations if possible or email it to or mail it to the address below. The consultation period runs from February 20, 2020 to July 20, 2020.

Health Product Inspection and Licensing Division
Health Product Compliance Directorate
13th Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney's Pasture
Address Locator # 1913D
Ottawa Ontario K1A 0K9

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