Notice of Intent to Adopt the Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients (ICH Topic Q7A) for APIs destined for veterinary use
Veterinary Drugs Directorate
Tower A, Ground Floor
11 Holland Avenue
Postal Locator 3000A
Ottawa, Ontario
K1A 0K9
December 30, 2003
To: Distribution List
Subject: Notice of Intent to Adopt the Good Manufacturing Practices Guide
for Active Pharmaceutical Ingredients (ICH Topic Q7A) for APIs destined
for veterinary use
The purpose of this letter is to inform you of Health Canada's Veterinary
Drugs Directorate's (VDD's) intention to adopt the Good Manufacturing
Practices (GMPs) Guide for Active Pharmaceutical Ingredients(APIs) (ICH
Topic Q7A) for APIs destined for veterinary use. This is a follow-up of
the Notice of Intent published in Canada Gazette Part I on December 7,
2002 advising the public of Health Canada's intention to proceed with
the development of a regulatory framework for APIs for human drugs. That
notice indicated Health Canada's intention to develop a regulatory framework
that would also allow the future implementation of GMP requirements for
APIs destined for veterinary use. It will be beneficial to all parties
to proceed with the development of the regulatory framework for human
and veterinary drugs concurrently. The scope of this notice is not to
suggest changes to the Q7A guideline itself, but to inform you of our
intent to adopt Q7A for APIs destined for veterinary use.
On September 12th, 2003, a meeting of the Task Force on Unapproved Drugs
was organized by the Canadian Animal Health Institute. During this meeting,
issues relating to compounding, importation of animal drugs and the use
of active pharmaceutical ingredients in veterinary medicine were discussed.
Representatives from the following organizations attended this inaugural
meeting: Veterinary Drugs Directorate and Health Products and Food Branch
Inspectorate (HPFBI),
Health Canada; the Canadian Food Inspection Agency; the Canadian Veterinary
Medical Association; l' Ordre des médecins vétérinaires
du Québec; the Ontario Veterinary Medical Association; the College
of Veterinarians of Ontario and the Canadian Animal Health Institute.
Those attending the meeting agreed that there needed to be greater controls
on the quality of APIs, and that APIs whether destined for human or veterinary
use, should be subject to the same quality requirements.
This is part of VDD's three-pronged approach to address the issue of
unapproved drugs, which encompasses activities related to compounding,
APIs and personal importation.
Background
Over the past decade, the extension of GMPs to 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 Guideline for APIs. A draft of this guideline 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, or has been,
implemented by the three ICH regions (USA, Japan and European Union).
Health Canada has adopted ICH Q7A Guideline for APIs for human use and
is developing a regulatory framework to ensure its implementation. You
may view the Good Manufacturing Practice Guide for Active Pharmaceutical
Ingredients on the following Web site:
http://www.hc-sc.gc.ca//dhp-mps/compli-conform/legislation/gazette1/
q7a_tc-tm_e.html
HPFBI is in the process of initiating consultation on the implementation
framework of the Good Manufacturing Practices Guide for Active Pharmaceutical
Ingredients (ICH Topic Q7A) for human therapeutics.
Proposed approach
With the HPFBI leading the regulatory framework development with respect
to GMPs for APIs, VDD will be moving ahead to extend the scope of the
ICH Q7A Guideline to include APIs destined for veterinary use. Until such
time as the regulatory framework is in place, VDD encourages the veterinary
industry to familiarize themselves and apply the principles outlined in
the ICH Q7A Guideline. However, whenever there is cause for safety concerns,
Health Canada will follow the HPFBI's Compliance and Enforcement Policy
(POL-0001).
Consultations
Comments on this notice may be sent to Ms. Dhurata Ikonomi, Public Involvement
Officer, at the above noted address by Friday, February 27, 2004.
HPFBI will be holding consultations in Spring 2004 to discuss the proposed
options for the development of a regulatory framework for GMPs for APIs.
Sincerely,
Diane C. Kirkpatrick
Director General
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