Harmonisation of Guidelines

New guidelines endorsed at VICH steering committee meeting

At its 17th meeting on 1-2 November 2005, the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) steering committee endorsed two guidelines for consultation at step 4^1,2.

The steering committee decided that the two guidelines, GL 24 - Pharmacovigilance of Veterinary Medicinal Products - Management of Adverse Event Reports and GL 42 - Pharmacovigilance of Veterinary Medicinal Products - Data Elements for Submission of Adverse Event Reports, should be open for a second public consultation for a minimum three-month period until 1 February 2006, rather than the more usual six-month period³. The second consultation is being held for transparency reasons as the initial consultation was three years ago when GL42 was part of GL24.

The steering committee also endorsed two guidelines at step 7 for implementation by the member regions^4,5. The two guidelines, GL 39 - Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances and GL 40 - Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products, should both be implemented by November 2006.

Background

The VICH steering committee meets twice a year and makes decisions such as selecting topics, releasing draft guidelines for consultation and adopting final guidelines for implementation in the member countries (the EU, Japan and the US)⁶.

There is a nine-step procedure that is followed in developing, implementing and revising guidelines:

• step one - the steering committee defines a priority item from a concept paper prepared by a member and appoints a working group if needed. A topic leader is given a mandate to draft a recommendation;
• step two - the expert working group drafts a recommendation;
• step three - the draft is submitted to the steering committee for approving its release for consultation;
• step four - following adoption by the steering committee, the draft recommendation is circulated for consultation;
• step five - the working group takes comments into consideration in preparing a revised draft. The topic leader must be a representative of a regulatory authority at this stage;
• step six - the revised draft recommendation is submitted to the steering committee for approval;
• step seven - a final recommendation and proposed implementation date are circulated to the relevant regulatory authorities;
• step eight - steering committee members report back on the implementation progress in their regions; and
• step nine - recommendations may be revised at the request of a member to take into account new scientific evidence.

References

1. GL 24 - Pharmacovigilance of Veterinary Medicinal Products - Management of Adverse Event Reports, November 2005, http://vich.eudra.org/htm/guidelines.htm

2. GL 42 - Pharmacovigilance of Veterinary Medicinal Products - Data Elements for Submission of Adverse Event Reports, November 2005, http://vich.eudra.org/htm/guidelines.htm

3. Personal communication, VICH secretariat, 13 December 2005

4. GL 39 - Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances, November 2005, http://vich.eudra.org/htm/guidelines.htm

5. GL 40 - Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products, November 2005, http://vich.eudra.org/htm/guidelines.htm

6. The nine steps of the VICH process, http://vich.eudra.org/htm/process.htm