OIE Regional Workshop on International/Regional Harmonisation of Veterinary Medicinal Products
(Bogor, Indonesia, 6-10 November 2006)
The OIE Regional Workshop was organised to provide national competent authorities with an opportunity to exchange experiences in different aspects of veterinary drug registration and regional networks and was hosted by the National Veterinary Drug Assay Laboratory (NVDAL), Bogor, Indonesia.
The focus was placed on national and regional registration procedures in ASEAN countries and, in particular, on international harmonisation, including of the OIE and the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), taking into consideration the existing mechanism of OIE standards and activities of the VICH.
The Workshop was attended by 12 participants involved in veterinary drug registration (two veterinary officers from each country: one engaged in the veterinary drug administration work and the other engaged in the veterinary drug assay laboratory work), in the respective countries, namely Cambodia, Indonesia, Laos, Malaysia, Philippines and Thailand (Brunei, Myanmar, Singapore and Vietnam were not able to participate in the Workshop, while those four countries were also invited to attend), observers from Indonesia (host country) and from the Asian Animal Health Association, which is a member of the International Federation for Animal Health (IFAH), and the OIE (Drs T. Fujita (6-7 November), Y. Oketani (8-10 November) and Y. Sakurai (6-10 November) from Regional Representation based in Tokyo); and Dr Koji Oishi and Dr Hideto Sekiguchi form the National Veterinary Assay Laboratory, Ministry of Agriculture, Forestries and Fisheries, Japan, Dr Herve Marion from the VICH Secretariat, Belgium, Dr R. Wasito from Gadjah Mada University and Dr Tjiptarjo Pronohartono from Veterinary Drug Association both in Indonesia as resource persons.
Dr Agus Heriyanto, Director of NVDAL, Dr T. Fujita, OIE Tokyo and Mr Mathur Riady, Director General of Livestock Services in Indonesia, delivered opening addresses, each of whom welcomed participants to the Workshop and stressed the importance of more efficient regional harmonisation of veterinary medicinal products registration, through mutual studies and the exchange of information among the member countries.
The Workshop discussed and reviewed various aspects of veterinary medicinal product control in the Region, including the introduction on the activities of VICH to promote international harmonisation of veterinary medicinal product registration as reference for the participants.
Each participating country from ASEAN reported its current situation on legal control and regulations on veterinary medicinal products, that is, the structure of the veterinary medicinal products administration office, the structure of the veterinary medicinal products assay laboratory, overview of the pharmaceutical industry in its country, domestic procedures of veterinary medicinal products registration and import/export situation of veterinary medicinal products.
Under those conditions, this Workshop discussed how to set up regional networks for harmonisation of veterinary medicinal products registration.
The Workshop finally produced “Conclusions and Recommendations for the Workshop” (attached).
Emphasis was put on the further strengthening functions of Veterinary Administrations in some countries for ensuring a national government mechanism of control and registration of medicinal products for veterinary use.
The Workshop requested the OIE to continue international cooperation for the region in order to support and strengthen activities of National Veterinary Administrations in conjunction with ensuring effective mechanism of veterinary drug registration and quality control of veterinary drugs, either locally produced or imported.
The regional networks should be developed to exchange information on veterinary medicinal products in order to improve quality assurance for veterinary vaccines marketed in the region and veterinary medicinal product registration. It was confirmed that Indonesia (NVDAL) as an ASEAN Focal Point for Animal Vaccines, the host institute of the Workshop, would continue to play a leading role in this matter, in particular, the regular organisation of regional seminars/workshops as well as electronic communication (e-mail, etc.).
The Workshop, which was successfully organised, contributed to mutual understanding on the situation of veterinary medicinal product registration among each participating countries.