Notice of Intent Published in Canada Gazette Part I, December 7, 2002
and
Good Manufacturing Practices Guide 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:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index_e.html
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:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index_e.html
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.
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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!
... Need to know how to market a new drug in Canada?
... Want information on the drug regulatory process?
... Need to know what the newest drugs on the
Canadian market are?
... Want direct access to forms and policies?
... Need to know the requirements for labelling drugs?
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_e.html
© 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
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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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