Final Conclusions and Recommendations of the OIE Regional Workshop on International/Regional Harmonisation of Veterinary Medicinal Products (Bogor, Indonesia, 6-10 November 2006)
OIE Regional Workshop on Veterinary Medicinal Products: Collaboration in information exchange, bioassay laboratory techniques and registration for ASEAN Countries considering that:
- The improvement of animal health is an essential factor for the development of the agriculture/livestock sector and poverty reduction by reducing human and animal health risks.
- Veterinary medicinal products are essential in animal disease prevention, control and treatment, and those will provide satisfactory results, only when they are produced and controlled in compliance with international standards and used in an effective way.
- There are existing mechanisms in participating ASEAN Member Countries of registration of veterinary medicinal products. However, the official control of veterinary drugs is vested in various national organisations that differ in their approach to ensuring the quality, safety and efficacy of the products.
- Veterinary drugs with low or doubtful safety and efficacy, often prevail for users in some part of the region, and under this condition, illegal trades have been identified.
- Indonesia (NVDAL) as an ASEAN Focal Point for Animal Vaccine, the host institute of the Workshop, has extended its cooperation in organising technical workshops for the region and played a leading role in conjunction with veterinary drug assay.
The Workshop recommends that:
- More attention should be paid to 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.
- International cooperation should be continued for the region in order to support and strengthen activities of National Veterinary Administrations in conjunction with ensuring effective mechanisms of veterinary drug registration and quality control of veterinary drugs, either locally produced or imported. The cooperation should focus on the development of human resources who are involved in veterinary drugs control and registration in the forms of training on information, risk analysis of veterinary drugs, registration and drug assay at the laboratory, to meet international requirements and standards.
- 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. In particular, the regular organisation of regional seminars/workshops as well as electronic communication.
- Assessment should be made on possibly creating/strengthening national/assay laboratories for the control of veterinary drugs, which will receive international cooperation.
The Workshop noted the importance of Harmonisation of Veterinary Medicinal Products Registration and in particular thanked the VICH Secretariat for the insightful presentation on their recent activity.