Consultation: Draft Documents for Post-Market Reporting Compliance (PMRC) Inspection Program

Comments are requested on the following draft documents:

• Risk Classification of Post-Market Reporting Compliance Observations (GUI-0063)
• Post-Market Reporting Compliance (PMRC) Guidelines (GUI-0102)

Background:

The Food and Drug Regulations, more specifically sections C.01.016 to C.01.020, and C.08.007 and C.08.008,set forth regulatory requirements for manufacturers, which includes Marketed Authorisation Holders (MAH) and importers, regarding the reporting of adverse drug reactions and the reporting of unusual failures in efficacy of new drugs to Health Canada. As part of Health Canada's mandate to maximize the safety, quality and efficacy of health products, Health Canada implemented on August 1, 2004, an inspection programme for PMRC. The PMRC inspection program is intended to verify that manufacturers are in compliance with the regulatory requirements including but not limited to, the receipt, analysis and submission of drug safety information to Health Canada, such as the reporting of domestic and foreign adverse drug reactions within 15 days, the preparation of annual summary reports, the maintenance of records related to reports, case reports and unusual failures in efficacy, as well as the reporting of domestic cases of unusual failures in efficacy for new drugs within 15 days.

Information on the Documents:

The document Risk Classification of Post-Market Reporting Compliance Observations (GUI-0063) being consulted on has been reviewed as part of the Inspectorate program's quality management process and has been amended. Highlights of the document are as follows.

• The list of observations was reorganized according to adverse drug reaction (ADR) reporting regulations, instead of according to risk.
• The list of products under the scope of the PMRC inspection program was reviewed.
• Examples of observations were added.
• Examples of observations were added based on the expectations outlined in the new document Post-Market Reporting Compliance Guidelines (GUI-0102).

The document Post-Market Reporting Compliance (PMRC) Guidelines (GUI-0102) being consulted on has been developed to describe the Inspector's expectation when conducting PMRC inspections.

Please see below to comment on these 2 consultations.

How to Get Involved and Deadline

Both consultations below are open for comment for 90 days, starting July 5, 2011 until October 4, 2011.

To request documents: Interested stakeholders who wish to provide comments may send a request for an electronic copy or alternate format of any of the documents to pmrc-cedac@hc-sc.gc.ca.

Please include in the subject line, the title and the preferred language of the consultation document you wish to receive.

Comments received from stakeholders and interested parties will be reviewed after the 90 day comment period.

Interested parties are encouraged to provide comments and suggestions by October 4, 2011 on any of the above documents.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.
Any questions or comments should be addressed to pmrc-cedac@hc-sc.gc.ca.

Yours truly

Diana Dowthwaite
Director General