Presentation on theme: "T. Fujita OIE Regional Representative for Asia and the Pacific"— Presentation transcript:
1T. Fujita OIE Regional Representative for Asia and the Pacific ＯＩＥ Regional Workshop on Harmonisation of Veterinary Medicinal ProductsT. FujitaOIE Regional Representative for Asia and the Pacific
2Contents Livestock Development in Asia OIE – its roles and International Standards (OIE Code and OIE Manual)Risk analysis for Biologicals for Veterinary UseRoles of Official Bodies
3Development of the Livestock Sector Millions of rural households in Asia depending on their livestock for food, animal energy and incomeRapid increase of livestock production in response to the strong demand from consumers, especially in Asia (3.5-5 % per year/FAO)High potential of Growth of the livestock sector, particularly in developing countries
4Major Constraints against Livestock Development?? Major constraints of Livestock Development include; Animal diseases, especially transboundary/emerging animal diseases (majority of them; zoonoses giving impacts to human health)Importance of Animal disease control in conjunction with (1) Livestock Productivity, (2) Human risks including Food safety and Consumers’ confident in food in case of zoonosis and (3) International trade (WTO-SPS)
6The OIE World Organisation for Animal Health an intergovernmental organisationfounded in 1924by 28 countriespredates the UN167 Member Countriesheadquarters in Paris5 Regional Representatives
7OIE Roles (1)OIE mandate: “improve animal health (including zoonosis) worldwide”Provision of animal health and veterinary scientific information (e.g. AI information)Obligation on international notification by Member Countries
8OIE Roles (2)International Standards on disease prevention and control, diagnosis and surveillance for assessment of animal health status*OIE Code*OIE Manual*RecommendationsOIE: International Standards-setting Organization on safety of international movements of animals and animal products (WTO-SPS)Strengthening (Capacity building) of Veterinary Services
9Terrestrial Animal Health Code OIE CodeTerrestrial Animal Health Code
10OIE Code OIE Terrestrial Animal Health Code To assure the sanitary safety of international trade in terrestrial animals and their productsThis is achieved through the detailing of health measures by the veterinary authorities of importing and exporting countries.
11The value of the CodeThe measures published are the result of consensus among the veterinary authorities of OIE Member Countries (now 167 countries) andIt constitutes a reference within WTO Agreement on the application of SPS as an international standard for animal health and zoonoses.The Code reference document for use by Veterinary Authorities, import/export services, epidemiologists and all those involved in international trade.
12Contents of the Code Description and approval of the Code contents: written by experts of international standingapproved by OIE Member CountriesReference documentation: under the WTO-SPS Agreement (OIE as the international reference organization for animal health by the WTO)
13(2 categories in the Code) Risk Analysis(2 categories in the Code)Risk analysis for Veterinary VaccinesRisk analysis for Biologicals for Veterinary Use other than Vaccines
14Risk Analysis for Veterinary Vaccines (1) (Introduction and principles)Veterinary Administrations of importing countries; to make available specific procedural requirements for approval or licensing of biologicals for veterinary use.Risk analysis for veterinary vaccines; to be founded on the principles of quality assurance (including quality control) in the production of veterinary vaccines.Exporting countries and importing countries; to agree on risk analysis models (qualitative or quantitative) to address specific issues and products.Risk analysis; to be as objective and transparent.
15Risk Analysis for Veterinary Vaccines (2) (Manufacturing practices)The products must be particularly well protected against contamination and cross-contamination.The environment (and the workers) must be protected, when the manufacturers use pathogenic (including to man) and exotic agents.The role of the quality assurance system is of the utmost importance.Recognized systems including specification on equipment, premise, qualification on personnel and quality assurances and regular inspections.
16Risk Analysis for Veterinary Vaccines (3) (Information to be submitted when applyingfor registration in the importing country)Responsibility of the manufacture or Veterinary Association of the exporting country to make available to the importing country the pharmacopoeia it uses.The importing country needs to have documented both the quality control methods used and the source of each batch of starting materials.The key steps of the manufacturing process of veterinary vaccines should be described in detail to help risk analysis (focusing on the quality and safety parts). The results of control tests during production and on finished products, as well as the sensitivity of these tests should be available.
17Risk Analysis for Veterinary Vaccines (4) (Categorization of veterinary vaccines)Countries should establish a system of categorization of veterinary vaccines, taking into consideration criteria such as pathogens used as active ingredients, their inherent characteristics and the risk they pose.(live vectored vaccines) The safety of the vector to the targeted and non-targeted species and to humans must be assessed. (potential tissue tropism or host range modification of the recombinant)
18Risk Analysis for Veterinary Vaccines (5) (Vaccinovigilance)Exporting countries and importing countries should ensure that a reliable system of vaccinovigilance (post licensing monitoring) is established to identify any serious problems encountered from the use of veterinary vaccines (regulartory programmes for veterinary vaccines, especially live vaccines)
19Risk Analysis for Veterinary Vaccines (6) (Risk communication)Reliable data in support of applications submitted in importing countries should be provided by the manufactures or the Veterinary Administration of the exporting countries.Relevant data on risk analysis, changes in animal health situations and vaccinovigilance should be shared by Veterinary Administrations on a continuous basis.
20Risk analysis for Biologicals for Veterinary Use other than Vaccines Categolization of biologicals; The categorisation system should take into account the source, the nature and the started purpose of the biologicals.Information to be submitted when applying for an import licenseRisk analysis processBiocontainment
21Manual of Diagnostic Tests and Vaccines for Terrestrial Animals OIE ManualManual of Diagnostic Tests and Vaccines for Terrestrial Animals
22OIE ManualOIE Manual (OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals): as internationally agreed diagnostic tests and vaccinesPurpose: to contribute to the international harmonization of methods for the surveillance and control of the most important animal diseases.Description: for laboratory diagnostic tests and the production and control of biological products (principally vaccines) for veterinary use across the globe.Protocols: referred to in the Terrestrial Animal Health Code
23OIE Manual Chapters(Introductory Chapters): sampling methods, good laboratory practice, principles of veterinary vaccine production, biotechnology, quality management in veterinary diagnostic laboratories, assay validation, tests for sterility, laboratory safe, the role of official bodies in the international regulation of veterinary biologicals, and antimicrobial susceptibility testing.( Disease Chapters): A summary that gives an overview of the tests and vaccines available for the disease, and a text for laboratory workers, giving details of diagnostic tests and the requirements for vaccines or diagnostic biologicals.
24Contents of the Manual General Animal Diseases - Quality management in veterinary testing laboratories- Principles of veterinary vaccine production, etc.Animal Diseases- 108 diseases (FMD, HPAI, CSF, etc.)- Multi-species diseases- Bovine diseases- Sheep and goats diseases- Equine diseases- Avian diseases- Swine diseases- Lagomorph diseases- Bee diseases- Others
25HPAI as an exampleA: Introduction; explanation of the diseaseB: Diagnostic techniquesC: Requirements for vaccines and diagnostic biologicals1. Seed management2. Method of manufacture3. In-process control4. Batch control; a) sterility, b) safety, c) potency, d) stability, e) preservatives, f) precautions5. Tests on the final products; a) safety, b) potency6. Novel vaccines
26Roles of Official bodies (1) Official control of veterinary biologicals; to be vested in various national and regional organisations that differ in their approach to ensuring the quality, safety and efficacy of the products.OIE Code and OIE Manual; to harmonize those national regulations internationally.
27Roles of Official bodies (2) OIE- Biological Standard Commission:To establish standards for diagnostic methods (including diagnostic preparations) and for vaccines-15 OIE Collaborating Centres;3 may be involved at some stage in veterinary vaccines control and/or harmonisation.-OIE’s Ad Hoc Group on the harmonization of veterinary medicines (1994), based on discussions with the International Technical Consultation on Veterinary Drug Registration (ITCVDR); the first step towards the creation of VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products)VICH-Trilateral Programme (EU-Japan-USA) aimed at harmonising technical requirements for veterinary product registrationFAO/IAEAe.g. PANVAC (Pan African Veterinary Vaccine Centre)(WHO)