Notice of Intent Published in Canada Gazette Parts I and II, December 7, 2002 and Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: ICH Topic Q7A

Contact Name: Policy and Strategic Planning Division
Tel: (613) 954-6785
Fax: (613) 952-9805
E-Mail: Insp_pol@hc-sc.gc.ca

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Cover Letter

Health Canada

FOOD AND DRUGS ACT

Food and Drug Regulations - Amendment

This notice is to advise the public of Health Canada's intention to proceed with the development of a regulatory framework for Active Pharmaceutical Ingredients (APIs).

Health Canada has a commitment to establish an open and transparent process for the development of regulatory frameworks and through this Notice of Intent, we would like to invite all interested parties to comment on the Health Canada, Health Products and Food Branch's (HPFB) proposal.

APIs destined for human use:

Over the past decade, the extension of Good Manufacturing Practices (GMP) to Active Pharmaceutical Ingredients (APIs) has been internationally recognized as a necessary element in ensuring the overall quality and consistency of marketed drug products. For this reason, the International Conference on Harmonization (ICH) formed a working group in 1997 to develop a GMP Guidance for APIs. A draft of this Guidance was published for comment by Health Canada in July 1999, followed by discussions with the pharmaceutical industry and associations as part of a workshop on selected ICH topics held in November of that year. The final consensus document entitled Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7A) was adopted by the ICH Steering Committee on November 10th, 2000, and is currently being implemented by the three ICH regions (USA, Japan and European Union).

Thus, Health Canada is adopting the ICH Q7A Guidance for APIs. A proposed regulatory framework will be developed in order to ensure the implementation of the ICH Q7A Guidance for APIs destined for human use.

You may view the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients on the following website:

APIs destined for veterinary use:

While the scope of the ICH Q7A Guidance is limited, by virtue of the mandate of ICH, to APIs that will be used in the manufacture of pharmaceuticals for human use, the principles and practices described are internationally recognized as having relevance to APIs for veterinary use.

Thus, it is the intent that the proposed regulatory framework will be designed to allow future implementation of GMP requirements for APIs destined for veterinary use.

Proposed approach:

Until such time as the regulatory framework is in place, Health Canada encourages industry to familiarize themselves and apply the principles outlined in the ICH Q7A Guidance. However, whenever there is cause for safety concerns, Health Canada will follow the HPFB Inspectorate's Compliance and Enforcement Policy (POL-0001).

In addition, a step staged approach will be used in order to facilitate a transition towards confidence building and a fully implemented framework.

Consultations:

Once proposed regulations are developed, they will be published within Canada Gazette Part I for a period of at least 75 days. We anticipate that the proposed regulations would be published for comment in the Spring of 2004.

This Notice of Intent is posted on the Health Products and Food Branch Inspectorate website at the following address:

Comments on this notice may be sent to the Policy and Regulations Division, National Coordination Centre, Health Products and Food Branch Inspectorate, 11 Holland Avenue, Tower A, 2nd Floor, Address Locator: 3002C, Ottawa, Ontario, K1A 0K9 by January 24, 2003 or by Email to Insp_pol@hc-sc.gc.ca or by fax at 613-952-9805.

Persons submitting comments should stipulate any parts of the comments that should not be disclosed pursuant to the Access to Information Act (in particular, pursuant to sections 19 and 20 of that Act), the reason why those parts should not be disclosed and the period during which they should remain undisclosed. Representations should also stipulate those parts of the comments for which there is consent to disclosure pursuant to the Access to Information Act.

Cover Page

Guidance for industry
Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
ICH Topic Q7A

Published by authority of the
Minister of Health

Date Adopted - 2002/10/03
Effective Date - The Effective Date will be the date the regulations associated with this guidance come into force.

Health Products and Food Branch
Guidance Document

Our mission is to help the people of Canada maintain and improve their health.

Health Canada

HPFB's Mandate is to take an integrated approach to the management of the risks and benefits to health related to health products and food by:

  • Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and,
  • Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.

Health Products and Food Branch

THERAPEUTIC PRODUCTS DIRECTORATE / BIOLOGICS AND GENETIC THERAPIES DIRECTORATE WEBSITE (S)

LET YOUR COMPUTER DO THE SEARCHING!

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All this and more is available on the

Therapeutic Products Directorate/Biologics and Genetic Therapies Directorate Website (s)
at
www.hc-sc.gc.ca/dhp-mps/index-eng.php

© Minister of Public Works and Government Services Canada 2002

Available in Canada through
Health Canada - Publications
Brooke Claxton Building, A.L. #0913A
Tunney's Pasture
Ottawa, Ontario
K1A 0K9

Tel: (613) 954-5995
Fax: (613) 941-5366

Également disponible en français sous le titre : Ligne directrice sur les bonnes pratiques de fabrication applicables aux ingrédients pharmaceutiques actifs

Catalogue No. E
ISBN

Foreword

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

In adopting this ICH guidance, Health Canada endorses the principles and practices described therein. This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidances.

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations. They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

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