Consultation - Invitation to Participate in the Survey for ICH Q7 Constituencies: Input for Development of a Question and Answer Document

Background

The Implementation Working Group (IWG) on Q7 (Q&A document) was created by the International Conference on Harmonization Steering Committee in October 2012. Health Canada is currently an observer on this IWG. As described in the  Q7 Q&A Concept Paper endorsed by the ICH Steering Committee on October 17, 2012, the main objective of the IWG is to develop a Question and Answer document on the ICH Q7 guideline, to help harmonize expectations during inspections, avoid ambiguities and uncertainties, and also help harmonize the inspections of both small molecules and biotech Active Pharmaceutical Ingredients (APIs).

On September 29, 2012, Health Canada proposed regulatory requirements amending the Food and Drug Regulations to extend GMP requirements to active ingredients (AIs). The proposal and the Regulatory Impact Analysis Statement (RIAS) for the proposal, were pre-published for public consultation in the Canada Gazette, Part I. The Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs) Guidelines (GUI-0104), were posted on Health Canada's website for comments. These draft guidelines provide interpretive guidance for the manufacture of APIs as per the proposed regulatory amendment and includes requirements of the ICH Q7 guideline. Therefore, your participation in this Survey will help ensure that any of your questions and issues with respect to the interpretation of the ICH Q7 guideline is considered by the IWG.

Information on the Document

You are invited to participate in a Survey for ICH Q7 Constituencies: Input for Development of a Q&A Document. At the time of development of the Q7 Q&A Concept Paper, certain technical issues for clarification were identified. However, in an attempt to promote transparency and collaboration with industry, the present document was prepared by the ICH Q7 Q&A IWG to allow the industry and regulatory authorities to identify and share areas of the ICH Q7 guideline which can then be addressed through the Q&A document. Highlights of this document are as follows:

• The Survey for ICH Q7 Constituencies: Input for Development of a Q&A Document is being shared by ICH and regulatory authorities of all countries that are member of the ICH Q7 Q&A IWG.
• The present document will undergo external and internal consultation concurrently, where applicable.
• The information collected from this survey will be anonymously shared within the Q7 IWG.

How to Get Involved and Deadline

The consultation period is open for comments and suggestions for 28 days, starting February 15, 2013 until March 15, 2013.

• To request the document: Interested stakeholders who wish to obtain an electronic copy or alternate format of the document can do so by sending an email to API_questions_IPA@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 28 day comment period.

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 API_questions_IPA@hc-sc.gc.ca.