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9th VICH Steering Committee launches VICH2 and approves more guidelines |
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The
Steering Committee of VICH (International Cooperation on
Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products) met in London, UK on 27 and 28 June 2001 and
reviewed the progress of the Expert Working Groups (EWGs). The
Steering Committee gave guidance to the Antimicrobial Resistance Expert
Working Group on the elaboration of statements related to prudent use of
antimicrobials which should be included as an appendix to the guideline
(GL) on Pre-approval information for registration of new veterinary
medicinal products for food producing animals with respect to
antimicrobial resistance (GL27). It also agreed that the Task Force on
Microbial Safety should meet two more times to finalise its
recommendations to the Safety WG on testing methods for identifying and
measuring the effects of antimicrobial drug residues on the human gut
flora. The appropriate revision at step 9 of GL10 – Impurities in new
veterinary drug substances and GL11 – Impurities in new veterinary
medicinal products was taken on board as a new topic to be dealt with in
writing by the existing Quality Working Group. With
the adoption by the Steering Committee of the guidelines on Efficacy of
Anthelmintics for equines (GL15), porcines (GL16), canines (GL19),
felines (GL20) and poultry (GL21), the Efficacy of Anthelmintics Working
Group has successfully finalised its mandate. These guidelines were
released for implementation by July 2002 and will be published in the
near future. Safety
guidelines GL 22 (reproduction testing) and GL23 (genotoxicity testing)
were adopted at step 6 pending final approval by the EU. These
guidelines will be released for implementation by August 2002. They will
be implemented in Japan when the guideline on the General Approach to
Testing is finalised. The pharmacovigilance guidelines GL24 (management
of Adverse Event Reports) was returned to the Working Group who is
requested to further address some outstanding issues. Step
4 guidelines were released for a 6-month public consultation period on:
1) pre-approval information for registration of new veterinary medicinal
products for food producing animals with respect to antimicrobial
resistance (GL27), 2) safety guidelines on carcinogenicity (GL28), 3)
pharmacovigilance management of Periodic Summary Update Reports (GL29)
and 4) pharmacovigilance controlled list of terms (GL30). The SC agreed
that VEDDRA (Veterinary Medicinal Dictionary for Drug Regulatory
Authorities) will form the basis for international terminology for
pharmacovigilance reporting. The
Steering Committee discussed the programme of the VICH2 conference to
take place in Tokyo, Japan on 10-11 October 2002. The first announcement is due to be circulated
in early autumn. VICH2 will focus on the progress achieved to date
whilst evaluating the implementation of the final guidelines. The
conference will also confirm the benefits of VICH and define the future
programme. The
10th meeting of the Steering Committee is scheduled for 28-29
November 2001 in Tokyo, Japan. For
further information, please contact the VICH Secretariat:
Observers |