VICH/02/028
19 April 2002
PRESS
RELEASE
10th
VICH Steering Committee finalises VICH2 Conference programme and
releases further Guidelines
The
Steering Committee of VICH
(International Cooperation on Harmonisation of Technical Requirements for
Registration of Veterinary Medicinal Products) met in Washington D.C., USA on 9,
10 and 11 April 2002 and reviewed the activities of the Expert Working Groups (EWGs).
The
Steering Committee finalised the programme of the VICH2 international conference
which will be hosted by Japan on 9 - 11 October 2002 in Tokyo. Since the VICH1
conference in 1999, a significant number of VICH Guidelines have been published
in draft form or as final Guidelines. Participants to the conference are
therefore warmly welcomed to take part in the discussions which will take place
in special breakout sessions where the following VICH topics will be addressed:
Ecotoxicity, Biologicals Quality Monitoring, Safety, Pharmacovigilance,
Antimicrobial Resistance, Target Animal Safety, Quality and Efficacy of
Anthelmintics.
Key-note
speakers from the EU, Japan and the USA, as well as from Australia and
New-Zealand will address special issues including: Quantifying Human Health
Impacts of VMP Regulations, the challenges to international harmonisation and
the role of regulatory authorities, the importance of VICH on a global
perspective and the future implications of the VICH process.
The Steering Committee reviewed the VICH work programme and confirmed the work plan for the forthcoming years.
Two
Guidelines were signed-off at step 6 VICH GL 25 – Testing of Residual
Formaldehyde and VCH GL 26 - Testing of Residual Moisture, and were released for
implementation in the 3 regions by May 2003.
The
Steering Committee released 3 new safety draft Guidelines at Step 4: VICH GL 31-
Safety of Residues of Veterinary Drugs in Human Food – Repeat-Dose (90 days)
Toxicity Testing , GL 32 - Safety of Residues of Veterinary Drugs in Human Food
– Developmental Toxicity Testing and GL 33 - Safety of Residues of Veterinary
Drugs in Human Food – General Approach to Testing, for a 5 months public
consultation period, in order to enable the safety EWG to finalise these draft
Guidelines at its 7th meeting, which will take place immediately
prior to the VICH2 conference in Tokyo.
VICH
draft Guideline 34 – Testing for the Detection of Mycoplasma Contamination,
was released for a 12 months public consultation period, pending the
availability of reference strains which will be provided by the European
Directorate for the Quality of Medicines (EDQM), and the Steering Committee
agreed to review the length of the public consultation period at its next
meeting.
The
Steering Committee acknowledged the progress achieved by the EWGs on Quality,
Ecotoxicity/Environmental Impact Assessment, Safety, Biologicals Quality
Monitoring, Pharmacovigilance, Antimicrobial Resistance and Target Animal Safety.
The
Steering Committee accepted the application of Canada to become an observer, and
of CAMEVET to become an Interested Party to the VICH Steering Committee.
The
11th meeting of the Steering Committee is scheduled for 8,9 and 12
October 2002 in Tokyo, Japan, prior and immediately following the VICH2
conference.
For
further information, please contact the VICH Secretariat:
c/o
IFAH, International Federation for Animal Health
Rue Defacqz, 1 - 1000 Brussels (Belgium)
Phone: +32-2-5410111, fax: +32-2-5410119,
E-mail: vich@ifahsec.org , Website: http://vich.eudra.org