ＯＩＥ Regional Workshop on Harmonisation of Veterinary

Medicinal Products

T. FujitaOIE Regional Representative for Asia

and the Pacific

Contents

• Livestock Development in Asia

• OIE – its roles and International Standards (OIE Code and OIE Manual)

• Risk analysis for Biologicals for Veterinary Use

• Roles of Official Bodies

Development of the Livestock Sector

•Millions of rural households in Asia depending on their livestocklivestock for food, animal energy and income

•Rapid 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

Major Constraints against Livestock Development??

• Major constraints of Livestock DevelopmentMajor constraints of Livestock Development include; Animal diseasesAnimal diseases, especially transboundary/emerging animal diseases (majority of them; zoonoses giving impacts to human health)

• Importance of Animal disease controlImportance 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)

The World Organization for Animal Health

(OIE)

The OIE

• World Organisation for Animal Health

• an intergovernmental organisation

• founded in 1924 – by 28 countries– predates the UN

• 167 Member Countries

• headquarters in Paris– 5 Regional Representatives

OIE 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

OIE Roles (2)• International Standards on disease prevention and

control, diagnosis and surveillance for assessment of animal health status

*OIE Code

*OIE Manual

*Recommendations

• OIE: International Standards-setting Organization on safety of international movements of animals and animal products (WTO-SPS)

• Strengthening (Capacity building) of Veterinary Services

OIE CodeTerrestrial Animal Health Code

OIE Code• OIE Terrestrial Animal Health Code

• To assure the sanitary safety of international trade in terrestrial animals and their products

• This is achieved through the detailing of health measures by the veterinary authorities of importing and exporting countries.

The value of the Code

• The measures published are the result of consensus 　　　

　　 among the veterinary authorities of OIE Member 　　 Countries (now 167 countries) and

• It 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.

Contents of the Code• Description and approval of the Code

contents:　　　　　 written by experts of international standing

approved by OIE Member Countries

• Reference documentation: under the WTO-SPS Agreement (OIE as the international reference organization for animal health by the WTO)

Risk Analysis

(2 categories in the Code)

• Risk analysis for Veterinary Vaccines

• Risk analysis for Biologicals for Veterinary Use other than Vaccines

Risk Analysis for Veterinary Vaccines (1)

(Introduction and principles)• Veterinary Administrations of importing countries; to mak

e 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.

Risk 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.

Risk Analysis for Veterinary Vaccines (3)

(Information to be submitted when applying for 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.

Risk 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)

Risk Analysis for Veterinary Vaccines (5)

(Vaccinovigilance)• Exporting countries and importing countries sho

uld 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)

Risk Analysis for Veterinary Vaccines (6)

(Risk communication)• Reliable data in support of applications submitte

d 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.

Risk 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 license

• Risk analysis process

• Biocontainment

OIE ManualManual of Diagnostic Tests and Vaccines for Terrestrial Animals

OIE Manual• OIE Manual (OIE Manual of Diagnostic Tests and

Vaccines for Terrestrial Animals): as internationally agreed diagnostic tests and vaccines

• Purpose: 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

OIE 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.

Contents of the Manual• General - 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

HPAI as an exampleA: Introduction; explanation of the disease

B: Diagnostic techniques

C: Requirements for vaccines and diagnostic biologicals

1. Seed management 2. Method of manufacture 3. In-process control 4. Batch control; a) sterility, b) safety, c) potency, d) stabilit

y, e) preservatives, f) precautions 5. Tests on the final products; a) safety, b) potency 6. Novel vaccines

Roles 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.

Roles of Official bodies (2)• OIE - Biological Standard Commission: To establish standards for diagnostic methods (including diagnostic preparations) and for vaccin

es

-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 requi

rements for veterinary product registration • FAO/IAEA e.g. PANVAC (Pan African Veterinary Vaccine Centre)

• (WHO)

Thank you for your attention !!