Control of veterinary products: the need for global standards

摘要

Veterinary medicinal products (VMPs) are key tools for protecting both public and animal health and therefore need to be, safe, efficacious and of high quality. These objectives can be attained at an international level if governance regarding VMPs iswell structured and international standards are developed and utilised.In the first part of this paper, the current situation regarding international harmonisation of standards for VMPs is presented, in particular the achievements to date of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) and International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) are considered, in addition to other relevant perspectives.The role of CCRVDF is to establish maximum residue limits for drugs used in veterinary medicine in order to protect consumer safety and to assure fair trade. The World Organisation for Animal Health (OIE) contributes to the development of consensus within theCCRVDF and acts as a partner to the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), both United Nations agencies, in the development of animal production food standards, guidelines, and related texts such as codes of practice.VICH is a trilateral (European Union-Japan-USA) programme aimed at harmonising the technical requirements for demonstrating product safety, efficacy and quality that are needed for veterinary product licensing or registration. VICH was created under theauspices of the OIE which participates in the VICH by providing oversight and direction as part of the VICH Steering Committee and helps to disseminate information to the 178 OIE Member Countries. By sharing VICH guidelines and principles, countries andregions can better understand the scientific basis and the public health and animal health protection principles that underlie the approval of veterinary medicines in the VICH-participating countries and can leverage that information as they may deem appropriate in their own national approval procedures.In the second part of the paper, improvement of the global governance of VMPs within the framework of the OIE Fifth Strategic Plan is presented, along with relevant objectives and methodology. The official governance of VMPs covers a wide range of responsibilities: registration, inspection, surveillance, communication, information-sharing, training, and other regulatory controls. In this way national Competent Authorities play a key role with respect tothe improvement of animal health, animal welfare, public health and the establishment of the required legislative base for relevant programmes and activities. Good governance, on the one hand, improves and supports the availability of VMPs and, on the other hand, is necessary to fight against fraud and the placement of counterfeit, ineffective or even dangerous products on the market. Regulatory controls of VMPs by national or regional Competent Authorities implemented through legislation that is harmonised, as appropriate, with international standards, are essential tools to ensure a high-quality and efficient market. In that way, good governance and veterinary legislation also support fair trade.In the last part of this paper, the difficulties in harmonising regulatory standards and the difficulties faced by science-based regulatory authorities in integrating risk assessment and risk management in the risk analysis decision-making process are described.