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Drugs and Health Products

Consultation on the Creation of a regulatory framework for the implementation of Good Manufacturing Practices for active pharmaceutical ingredients (API)

The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and contains the content that was open for submissions during the consultation period. Comments and suggestions received during the public consultation period are being considered.

Health Canada is currently conducting a consultation in order to provide the opportunity to comment on Health Canada's proposed regulatory framework for the purpose of implementing the International Conference on Harmonization (ICH) guideline Q7. Q7 is an internationally recognized guideline that was developed to provide internationally harmonized guidance regarding Good Manufacturing Practices (GMPs) for active pharmaceutical ingredients (APIs).

How to Get Involved

The consultation is open for comment starting September 17 until November 2, 2009. Interested stakeholders who wish to provide comments regarding the proposed amendments should send their comments via email or by mail to:

Policy and Strategic Planning Division

Policy and Strategic Planning Division
Health Products Food Branch Inspectorate
250 Lanark Avenue
Address Locator 2006C
Ottawa, Ontario
K1A 0K9

Cover letter

Comments received from stakeholders and interested parties will be reviewed after the 45 day comment period

Interested parties are encouraged to provide comments and suggestions by November 2, 2009 on the above document.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact us at: Policy and Strategic Planning Division

Yours truly

Original signed by

Diana Dowthwaite
Director General