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AgVetLink June 2005

Meeting with Canadian Regulators on GMP

Brian Pidford’s attendance at the 3rd VICH Conference on Harmonistation of Requirements for the Registration of Veterinary Medicines at Washington DC (see page 7) provided an opportunity to call on Canadian regulators in Ottawa to discuss matters of mutual interest relating to good manufacturing practice (GMP) of veterinary medicines.

The points of mutual interest for discussion, which were agreed before the meeting, fell into two categories – domestic programmes and international agreements. The domestic programme issues concerned:

• GMP standards

• training of GMP inspectors

• integration of product registration data with the GMP process

• equilibration of inspections carried out by different inspectors who are geographically separated

• application of GMP standards to manufacturers of varying size with operations of varying  complexity.  

The international agreements issues included:

• mutual recognition agreements (MRAs) with the EC

• the situation regarding the new EC member states

• MRA with the USA

• local implementation of amendments to EC Directives
a) continuous particle counting in Class A clean zones
b) GMP for manufacturers of active pharmaceutical ingredients possibility for closer technical collaboration between New Zealand and Canada on GMP.

Staff at Health Canada who regulate pharmaceutical products and at the Canadian Food Inspection Authority who regulate veterinary biologicals were very helpful and informative on their control programmes and their international partnership activities. They expressed an interest in considering the development of closer technical contacts on GMP for veterinary medicines with NZFSA.

GMP Agreement Signed with Australia
A Memorandum of Understanding has been signed between the NZFSA’s ACVM Group and the Australian Pesticides and Veterinary Medicines Authority (APVMA) for the acceptance of each party’s good manufacturing practice assessments and certification of manufacturers of veterinary medicines. The signing formalises a process that has been proceeding through strong technical contacts between the ACVM Group and the APVMA for a number of years.