Veterinary products

In this context, WOAH develops for its Member Countries international standards, guidelines and recommendations for veterinary products. These reference documents can be found in the five following publications: Terrestrial Animal Health Code, Aquatic Animal Health Code, Manual of Diagnostic Tests and Vaccines for Terrestrial Animals and the Manual of Diagnostic Tests for Aquatic Animals.

WOAH also actively promotes activities related to harmonisation of veterinary legislation. As an associated member, WOAH supports the initiative for an International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). Some specific collaborative activities and translated VICH Guidelines can be joined under VICH Outreach Forum.

WOAH also developed Practical Guidelines for National Procurement of Veterinary Vaccines to support its Members in the process of identifying and procuring quality assured veterinary vaccines. They also contribute to provide clear guidance on the information regarding the vaccines and the manufacturers required for the procurement process.

In parallel and in synergy with the development of international standards, guidelines and recommendations, WOAH provides a permanent support to Veterinary Services and laboratories to enable Members to implement them.

The work of the WOAH in the field of veterinary products is supported by three Collaborating Centres, which are world-leading institutes, and a Reference Laboratory on Antimicrobial Resistance.

Actions taken by Members are coordinated by the WOAH National Focal Points for veterinary products, who provide technical assistance to national Delegates in improving and harmonising national policies for veterinary products.

In May 2009, the World Assembly of Delegates adopted during the 77th General Session Resolution No. 25 on Veterinary products, which clearly recommends WOAH to strengthen its actions and to further develop a coherent strategy in this field. This position has since then been reflected in the Fifth Strategic Plan (2011–2015) of WOAH, which was adopted at the 78th WOAH General Session in May 2010 by this same Assembly.

Background

WOAH (founded as OIE) has been involved from the start in the formation of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and has been represented by its Collaborating Centre ANSES in all its Steering Committee Meetings.

As indicated in its 5th Strategic Plan, WOAH encourages the use of VICH Guidelines by its Member Countries and in order to facilitate this, engaged with VICH to support the process of setting up the VICH Forum in which non-VICH members countries and regions can participate and learn first-hand about the VICH process. The VICH Forum aims to provide a basis for wider international harmonisation of technical registration requirements necessary for the marketing authorisation (also called “registration”) of a veterinary medicinal product.

The VICH Forum was created during the 26th VICH Steering Committee meeting, held in Tokyo, Japan, in November 2011. A number of countries and regional organisations which meet the criteria laid down in the Terms of Reference for this Forum, have since then met for the inaugural Forum, held in Brussels in June 2012 and subsequent Forum meetings, which take place at the time of VICH Steering Committee meetings.

The key issues of interest to the non-VICH countries coming together in the Forum are to better understand and actively contribute to the VICH Guideline development process, to suggest topics for new Guidelines, to provide feedback on the acceptance of existing guidelines and to discuss practical issues related to VICH guidelines, to receive training in the application of the Guidelines and to collaborate and share translations of guidelines into other languages.

Current members of the Forum

Countries

Argentina, Botswana, Brazil, Brunei, Burkina Faso, People’s Republic of China, Egypt, India, Korea, Malaysia, Mexico, Morocco, Nigeria, Rwanda, Russia, Saudi Arabia, Singapore, Taipei, Taiwan, Tanzania, Thailand, The Philippines, United Arab Emirates,
Uganda, Ukraine, Zambia, Zimbabwe (Observer: South Africa)

Regional organizations

ASEAN (representing Asia)

CAMEVET (representing the Americas)

CAPROVE

EAC (representing East African Community) 

SADC (representing South African Development Community) 

WAEMO/UEMOA (representing West Africa) 

The role of WOAH

WOAH and its Collaborating Centre ANSES facilitate the relation and communication between Forum members, the VICH Secretariat and the VICH members. Minutes of the Forum meetings and other documents of relevance for Forum member countries and WOAH Member Countries interested in joining the Forum can be found on this webpage.

• Concept Paper GL
• VICH and its role in the authorization of VMP (eng – arab)

Meetings of the VICH Forum

• Inaugural Forum meeting, Tokyo (Japan), 15 – 16 November 2011 (minutes)
• 1st Forum meeting, Brussells (Belgium), 26 – 27 June 2012 (minutes)
• 2nd Forum meeting, Washington DC (USA), 19 – 20 February 2013 (minutes – press release)
• 3rd Forum meeting, Auckland (New Zealand), 12 – 13 November 2013 (minutes – press release)
• 4th Forum meeting, Brussels (Belgium), 24 – 25 June 2014 (minutes – press release)
• 5th Forum meeting, Washington DC (USA), 24 – 25 February 2015 (minutes – press release)
• 6th Forum meeting, Tokyo (Japan), October 2015 (minutes – press release)
• 7th Forum meeting, Brussels (Belgium), 21-22 June 2016 (minutes – press release)
• 8th Forum meeting, Buenos Aires (Argentina), 27 February – 2 March 2017 (minutes – press release)
• 9th Forum meeting, Tokyo (Japan), 14 – 15 November 2017 (minutes – press release)
• 10th Forum meeting, Bruges (Belgium), 26 – 27 June 2018 (minutes – press release)
• 11th Forum meeting,  Cape Town (South Africa), 25 – 26 February 2019 (minutes – press release)
• 12th VICH Forum meeting,  Tokyo (Japan), 19 – 20 November 2019 (minutes – press release)
• 13th VICH Forum meeting,  Virtual, 17 November 2020 (minutes – press release)
• 14th VICH Forum meeting,  Virtual, 16 November 2021 (minutes – press release)
• 15th VICH Forum meeting, USA, 15 November 2022 (minutes – press release)
• 16th VICH meetings, Tokyo, Japan, 13-16 November 2023 (minutes – press release)

12th Forum Meeting – 38th Steering Committee
Tokyo (Japan), November 2019

Next meeting of the VICH Forum

• 43rd VICH Steering Committee meeting, together with the 17th VF meeting, and 7th VICH public conference will be held in Amsterdam ( European Medicines Agency ) The Netherlands, from 10 to 15 November 2024. The public conference is open to all interested parties and will take place on Wednesday 13 and Thursday 14 .

Service to Forum members

A need has been identified by Forum members for VICH Guidelines to be translated into other languages. WOAH, in collaboration with other organisations, makes those Guidelines which are already translated, available on this website. It needs, however, to be noted that only the English version as found on the VICH website is considered original and binding.

These Guidelines can be found as pdf files hereunder.

Russian (translated byWOAH)

VICH GL 3

VICH GL 8

Spanish (translated by FDA see U.S. Food and Drug Administration)

VICH GL 3R	VICH GL 29
VICH GL 9	VICH GL 31
VICH GL 22	VICH GL 32
VICH GL 23	VICH GL 37
VICH GL 28

French (translated by Health Canada, Veterinary Drugs Directorate, in 2004 and as otherwise indicated)  

VICH GL 1	VICH GL 12	VICH GL 21
VICH GL 2	VICH GL 13	VICH GL 22R
VICH GL 3	VICH GL 14	VICH GL 23
VICH GL 4	VICH GL 15	VICH GL 28 (2005)
VICH GL 5	VICH GL 16	VICH GL 31R
VICH GL 7	VICH GL 17	VICH GL 32R
VICH GL 8	VICH GL 18	VICH GL 33R
VICH GL 10	VICH GL 19	VICH GL 36 (2007)
VICH GL 11	VICH GL 20	VICH GL 37

Diagnostic tests are essential tools for confirming the health status of animals and identifying pathogens. They enable the early detection, management and control of animal diseases including zoonosis and facilitate the safe trade in animals and animal products.

WOAH works actively on veterinary products, including diagnostic tests, and has developed a coherent strategy for its activities in this area.

WOAH standards that apply to diagnostic tests are published in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual) and in the Manual of Diagnostic Tests for Aquatic Animals (Aquatic Manual).

In the introductory chapters of both Manuals, topics such as the collection, shipment and storage of diagnostic specimens, the quality management in veterinary laboratories, or the principles of validation of diagnostic tests are addressed.

For all listed diseases as well as several other diseases of importance, the two Manuals specify and detail the internationally agreed upon diagnostic test methods.

These standards, guidelines and recommendations are regularly updated to take account of the latest scientific findings and technological developments.

WOAH’s work is guided by the Biological Standards Commission and the Aquatic Animal Health Commission in their respective areas of competence and supported by several Reference Laboratories and Collaborating Centres. WOAH-approved International Standard Sera have been developed by Reference Laboratories for certain diseases.

WOAH-approved International Standard Reagents

The Biological Standards Commission coordinates a programme for the preparation, validation and distribution of WOAH-approved International Standard Reagents for diagnostic assays for infectious diseases of animals. The standards are prepared using this template by a Reference Laboratory in accordance with Guidelines for antibody, antigen and polymerase chain reaction (PCR) standards drawn-up by the Commission in collaboration with other laboratories. Such standard preparations are designated by the WOAH as primary reference standards for use in conjunction with tests described in the WOAH Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (mammals, birds and bees). The aim of the programme is to harmonise diagnostic testing and encourage the mutual recognition of test results for international trade.

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Currently available WOAH-approved International Standard Reagents
 

Disease	Test	Available from
African horse sickness	Enzyme-linked immunosorbent assay	Marisa Arias Centro de Investigación en Sanidad Animal Instituto Nacional de Investigación y Tecnología Agraria y Alimentarie (CISA-INIA) 28130 Valdeolmos, Madrid, Spain Tel: (34-91) 620.23.00 [email protected]
Aujeszky’s disease	Enzyme-linked immunosorbent assay; Virus neutralisation	Dr Marie-Frédérique Le Potier Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (Anses) Laboratoire de Ploufragan/Plouzané/Niort Unité de Virologie Immunologie Porcines B.P. 53, 22440 Ploufragan/Plouzané/Niort France Tel: +33 (0)2 96 01 62 90 [email protected]
Bluetongue	Enzyme-linked immunosorbent assay; Agar gel immunodiffusion	To be decided National Veterinary Services Laboratories USDA, Veterinary Services P.O. Box 844, Ames Iowa 50010, United States of America Tel: (1-515) 337.75.51 [email protected] https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/lab-info-services/sa_reagents/ct_reagents
Bovine brucellosis	Indirect and Competitive enzyme-linked immunosorbent assay; Complement fixation; Agglutination; Buffered Brucella antigen tests; Fluorescence polarisation assay	Dr Adrian Whatmore Animal and Plant Health Agency New Haw, Addlestone Surrey KT15 3NB, United Kingdom Tel: (+44-1932) 35.76.10 [email protected]
Brucella abortus	Complement fixation; Agglutination; Buffered Brucella antigen tests; Fluorescence polarisation assay; Indirect and Competitive enzyme-linked immunosorbent assay	Dr Adrian Whatmore (as above)
Brucella ovis	Complement fixation	Dr Adrian Whatmore (as above)
Classical swine fever	Virus neutralisation	Dr Helen Crooke Animal and Plant Health Agency New Haw, Addlestone Surrey KT15 3NB, United Kingdom Tel: (44-208) 026 9665 [email protected]
Contagious bovine pleuropneumonia	Both irradiated and non-irradiated sera are available. Please contact the Reference Laboratory for advice on their suitability for different types of serological test (complement fixation test, indirect or competitive enzyme-linked immunosorbent assay)	Dr Massimo Scacchia Istituto Zooprofilattico Sperimentale dell’Abruzzo e del Molise ‘G. Caporale’ Via Campo Boario, 64100 Teramo, Italy Tel: (39-0861) 33.24.05 [email protected]
Contagious bovine pleuropneumonia	Complement fixation test	Dr Ana Rosa Pombo Botelho Instituto Nacional de Investigação Agrária e Veterinária (INIAV, IP) Av. da República, Quinta do Marquês s/n, 2780-157 Oeiras, Portugal Tel: +351-21 440 35 14 [email protected]
Enzootic bovine leukosis	Agar gel immunodiffusion; Enzyme-linked immunosorbent assay	Prof. Thomas Vahlenkamp Institute of Virology Centre for Infectious Diseases Faculty of Veterinary Medicine Leipzig University, An den Tierkliniken 29 04103 Leipzig, Germany Tel: (49-341) 97.38.201 [email protected]
Equine infectious anaemia	Agar gel immunodiffusion	Dr Stephan Zientara UMR Virologie Anses/INRA/ENVA 23 avenue du Général de Gaulle 94703 Maison-Alfort, France Tel: 33 (0)1 43.96.72.82 [email protected] [email protected]
Equine influenza	Haemagglutination inhibition; single radial haemolysis	Dr Marie-Emmanuelle Behr-Gross European Directorate for the Quality of Medicines, Council of Europe 7 allée Kastner, F-67081 Strasbourg Cédex, France Tel: 33 (0)3 90.21.41.08 [email protected]
Equine influenza	Antigens and antisera for in-vitro standardisation of vaccines	NIBSC (National Institute for Biological Standards and Control) P.O. Box 1193, Blanche Lane South Mimms, Potters Bar Hertfordshire EN6 3QH United Kingdom Tel: (+44-1707) 64.14.67 [email protected]
Equine viral arteritis	Virus neutralisation	Dr Peter J. Timoney Maxwell H. Gluck Equine Research Center Department of Veterinary Science University of Kentucky, Lexington Kentucky 40546-0099 United States of America Tel: (1-859) 47 57 ext. 81094 [email protected]
Foot and mouth disease	Enzyme-linked immunosorbent assay (antigen and antibody detection); Virus neutralisation	Dr Donald King The Pirbright Institute Ash Road, Pirbright Woking, Surrey GU24 0NF, United Kingdom Tel: (44-1483) 23.24.41 [email protected]
Foot and mouth disease	Nonstructural protein tests	Dr Edviges Maristela Pituco Centro Panamericano de Fiebre Aftosa OPS/OMS Av. President Kennedy 7778, Sao Bento Duque de Caxias, ZC 25040-004 Rio de Janeiro, Brazil Tel: (55-21) 36.61.90.64 [email protected]
Infectious bovine rhinotracheitis	Virus neutralisation; Enzyme-linked immunosorbent assay	Dr Stephen Valas Laboratoire de Ploufragan-Plouzané-Niort Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (Anses) 60 rue Pied de Fond, CS 28440 79024 Niort Cedex, France Tel: 33 (0)5 49.79.61.28 [email protected]
Ovine and caprine brucellosis (anti-Brucella melitensis[ISaBmS])	Indirect and Competitive enzyme-linked immunosorbent assay; Fluorescence polarisation assay; Buffered Brucella antigen tests	Dr Adrian Whatmore (as above)
Peste des petits ruminants	Enzyme-linked immunosorbent assay	Dr Arnaud Bataille CIRAD-Bios, Campus international de Baillarguet TA A-15/G, B.P. 5035, 34398 Montpellier Cedex 15, France Tel: 33 (0)4 67 59 37 98 [email protected]
Rabies	Fluorescent antibody virus neutralisation	Dr Florence Cliquet Anses Nancy, Laboratorie de la rage et de la faune sauvage Technopôle Agricole et Vétérinaire Bâtiment H, CS 40009, 54220 Malzéville, France Tel: 33 (0)3 83.29.89.50 [email protected]
Swine vesicular disease	Enzyme-linked immunosorbent assay (antibody detection);Virus neutralisation	Dr Donald King The Pirbright Institute, Ash Road, Pirbright, Woking, Surrey, GU24 0NF, United Kingdom Tel: (44-1483) 23.24.41 [email protected]
Trichinellosis	Enzyme-linked immunosorbent assay	Dr Maria Angeles Gomez Morales Istituto Superiore di Sanita, Laboratorio di Parassitologia Viale Regina Elena 299, 00161 Roma, Italy Tel: +390-6 49.90.23.04 [email protected]

The term ‘International Standard Reagent’ is synonymous with primary standard. It represents the standard by which all others (secondary standards) are compared and calibrated. Secondary standards may represent national standards or working standards that are in routine use at the diagnostic laboratory level. The secondary standard and not the International Standard are to be used on a daily basis to standardise testing. The International Standard Reagents listed above may be obtained, in small quantities, at the corresponding address. Some laboratories may make a charge for this service.

Should you contact one of these Reference Laboratories to obtain reference materials and get no response, please inform the Scientific Department.

Legal Basis

During the 71st General Session of the WOAH in May 2003, the International Committee adopted Resolution No. XXIX. This Resolution endorses the principle of validation and certification of diagnostic assays (test methods) for infectious animal diseases by the WOAH and gives a mandate to the Director General of the WOAH to set up the specific standard procedures to be used before the final decision on the validation and certification of the diagnostic assay is taken by the WOAH International Committee.

The Resolution establishes that ‘fitness for purpose’ should be used as a criterion for validation.

The concept of ‘fitness for purpose’ indicates the purpose of the test, e.g.: 1. To demonstrate population ‘freedom’ from infection (prevalence apparently zero)      a) ‘free’ with and/or without vaccination,      b) historical ‘freedom’,      c) re-establishment of ‘freedom’ following outbreaks; 2. To demonstrate freedom from infection or agent in individual animals or products for trade purposes; 3. To demonstrate efficiency of eradication policies; 4. To confirm diagnosis of clinical cases; 5. To estimate prevalence of infection to facilitate risk analysis (surveys, classification of herd health status, implementation of disease control measures); 6. To determine immune status in individual animals or populations (post-vaccination).

The Resolution states that the Director General of the WOAH should make provisions to establish a registry of assays with levels of validation specified. He is given the mandate to review the procedures involved in the timely approval of assays and is authorised to recover, if necessary, any costs incurred in the process of validation, certification and registry of such assays.

Resolution No. XXIX establishes that WOAH Reference Laboratories should be intimately involved with the validation procedures and that they should establish serum/sample reference collections to be used for validation in line with their mandates.

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Purpose and relevance of the Procedure and of the Register

The aim of the WOAH procedure for registration of diagnostic kits is to produce a register of recognised diagnostic kits for WOAH Member Countries and for kit manufacturers.

WOAH Member Countries need diagnostic kits that are known to be validated according to WOAH criteria in order to improve the quality of kits, to ensure that the kits can be used to correctly establish animal disease status and to enhance confidence in kits.

This process of producing a register of recognised diagnostic kits will provide greater transparency and clarity of the validation process.

It will also provide means for recognising those manufacturers that produce validated and certified test methods in kit format.

In order to render the process transparent, all results of this registration procedure by the WOAH will be included in detailed form on the WOAH web site.

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Policy on Transparency, Confidentiality and Disclosure of information

WOAH faces potentially conflicting obligations of ensuring public access to information (transparency) and safeguarding confidentiality of information that WOAH holds in its role as international regulatory organisation (see also WOAH Policy on the Protection of Legitimate Confidentiality available on WOAH website at: https://www.woah.org/en/about-us/key-texts/experts-obligations/).

1. Duty of confidentiality

Within the framework of the WOAH Procedure for Registration of Diagnostic Kits, the respect of confidentiality is an essential part of maintaining a good relationship and balance between the WOAH, industry and other parties. The WOAH recognises that its staff, the Biological Standards Commission (BSC) and the Aquatic Animal Health Standards Commission (AAHSC) members, and reviewers may have access to confidential information related to intellectual property or of commercial concern. For this reason, they are all required to sign a confidentiality undertaking with the obligation to respect confidentiality of information in all circumstances and even after their current assignments/contract.

WOAH staff members are subject to a general duty of confidentiality under the Staff Regulations. The attention of new members of staff is drawn to the relevant provisions contained in the Staff Regulations. They acknowledge in writing that they have read and understood the relevant articles on the confidentiality provisions in the Staff Regulations and the related disciplinary measures. Staff members are required to repeat this acknowledgement on renewal of contract.

WOAH staff and other individuals involved in the WOAH Procedure for Registration of Diagnostic Kits are advised to exercise care when answering questions so as not to supply information to competitors or other interested parties regarding specific products where such information does not belong to the public domain. Discretion should be exercised within or outside the WOAH.

Where there is doubt about the management of information, WOAH staff members and other individuals involved in the WOAH Procedure for Registration of Diagnostic Kits seek guidance from the Director General of the WOAH.

2. Continuing duty of confidentiality

Members of the WOAH Specialist Commissions, reviewers and staff have a life-long duty of confidentiality even after they have ceased their relationship with the WOAH.

Form 1: Confidentiality Undertaking for the Expert Advisers 

Form 2: Confidentiality Undertaking for the staff of the WOAH, and the Biological Standards Commission and Aquatic Animal Health Standards Commission members

Procedure for submission

Download application form

The register of diagnostic kits certified by the WOAH