Veterinary products are important tools in the prevention and control of animal diseases. The definition of veterinary products may vary from one country to another; for OIE purposes, they include vaccines, veterinary medicines, such as antimicrobial agents, and diagnostic kits. To ensure effective and sustainable animal disease control while minimising risks to humans and animals, governments are expected to provide appropriate regulations on the authorisation, manufacturing, distribution and use of veterinary products through their veterinary legislation.
In this context, the OIE 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.
The OIE also actively promotes activities related to harmonisation of veterinary legislation. As an associated member, the OIE 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.
In parallel and in synergy with the development of international standards, guidelines and recommendations, the OIE provides a permanent support to Veterinary Services and laboratories to enable OIE Member Countries to implement them.
Actions taken by OIE Member Countries are coordinated by the OIE 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 OIE General Session Resolution No. 25 on Veterinary products, which clearly recommends the OIE 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 the OIE, which was adopted at the 78th OIE General Session in May 2010 by this same Assembly.
The 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 the OIE 5th Strategic Plan, the OIE encourages the use of VICH Guidelines by its Members Countries and in order to facilitate this, engaged with VICH to support the process of setting up the VICH Outreach Forum in which non-VICH members countries and regions can participate and learn first-hand about the VICH process. The VICH Outreach 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 Outreach 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 Outreach Forum, held in Brussels in June 2012 and subsequent Outreach 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 Outreach Forum
Argentina, Brazil, China (Pep. Rep. of), India, Korea (Rep. of), Mexico, Morocco, Nigeria, Russia, Saudi Arabia, Chinese Taipei, Tanzania, Thailand, Uganda, Ukraine and Zimbabwe.
ASEAN (representing Asia)
CAMEVET (representing the Americas);
WAEMO/UEMOA (representing West Africa)
The role of OIE
The OIE and its Collaborating Centre ANSES facilitate the relation and communication between Outreach Forum members, the VICH Secretariat and the VICH members. Minutes of the Outreach Forum meetings and other documents of relevance for Forum member countries and OIE Member Countries interested in joining the Forum can be found on this webpage.
Meetings of the VICH Outreach Forum
- Inaugural Outreach Forum meeting, Tokyo (Japan), 15 – 16 November 2011 (minutes)
- 1st Outreach Forum meeting, Brussells (Belgium), 26 – 27 June 2012 (minutes)
- 2nd Outreach Forum meeting, Washington DC (USA), 19 – 20 February 2013 (minutes – press release)
- 3rd Outreach Forum meeting, Auckland (New Zealand), 12 – 13 November 2013 (minutes – press release)
- 4th Outreach Forum meeting, Brussels (Belgium), 24 – 25 June 2014 (minutes – press release)
- 5th Outreach Forum meeting, Washington DC (USA), 24 – 25 February 2015 (minutes – press release)
- 6th Outreach Forum meeting, Tokyo (Japan), October 2015 (minutes – press release)
- 7th Outreach Forum meeting, Brussels (Belgium), 21-22 June 2016 (minutes – press release)
- 8th Outreach Forum meeting, Buenos Aires (Argentina), 27 February – 2 March 2017 (minutes – press release)
- 9th Outreach Forum meeting, Tokyo (Japan), 14 – 15 November 2017 (minutes – press release)
- 10th Outreach Forum meeting, Bruges (Belgium), 26 – 27 June 2018 (minutes – press release)
- 11th Outreach Forum meeting, Cape Town (South Africa), 25 – 26 February 2019 (minutes – press release)
- 12th VICH Outreach Forum meeting, Tokyo (Japan), 19 – 20 November 2019 (minutes – press release)
- 13th VICH Outreach Forum meeting, Virtual, 17 November 2020 (minutes – press release)
12th Outreach Forum Meeting – 38th Steering Committee
Tokyo (Japan), November 2019
Next meeting of the VICH Outreach Forum
- 14th VICH Outreach Forum meeting, Europe (TBD), November 2021
Service to the Outreach Forum members
A need has been identified by Outreach Forum members for VICH Guidelines to be translated into other languages. OIE 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 by OIE)
Spanish (translated by FDA see U.S. Food and Drug Administration)
French (translated by Health Canada, Veterinary Drugs Directorate, in 2004 and as otherwise indicated)
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.
The OIE works actively on veterinary products, including diagnostic tests, and has developed a coherent strategy for its activities in this area.
The OIE 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 the OIE 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.
OIE’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. OIE-approved International Standard Sera have been developed by Reference Laboratories for certain diseases.
OIE-approved International Standard Reagents
The OIE Biological Standards Commission coordinates a programme for the preparation, validation and distribution of OIE-approved International Standard Reagents for diagnostic assays for infectious diseases of animals. The standards are prepared by an OIE 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 OIE as primary reference standards for use in conjunction with tests described in the OIE 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.
Currently available OIE-approved International Standard Reagents
|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
Fax: (34-91) 620.22.47
[email protected] / [email protected]
|Aujeszky’s disease||Enzyme-linked immunosorbent assay;|
|Dr Marie-Frédérique Le Potier|
Anses Ploufragan, Laboratoire de Ploufragan/Plouzané
Unité de Virologie Immunologie Porcines
ZOOPOLE LES CROIX
22440 Ploufragan, France
Tel: +33 (0)2 96 01 62 90
Fax: +33 (0)2 96 01 62 94
|Bluetongue||Enzyme-linked immunosorbent assay;|
Agar gel immunodiffusion
|To be decided|
National Veterinary Services Laboratories, Animal & Plant Health Inspection Service, USDA, P.O. Box 844, 1920 Dayton Avenue, Ames, Iowa 50010, United States of America
Tel: (1-515) 337.75.51
Fax: (1-515) 337.65.08
|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
Tel: (+44-1932) 35.76.10 Fax: (+44-1932) 35.72.16
|Brucella abortus||Complement fixation; Agglutination; Buffered Brucella antigen tests; Fluorescence polarisation assay; Indirect and Competitive enzyme-linked immunosorbent assay||Dr Adrian Whatmore|
|Brucella ovis||Complement fixation||Dr Adrian Whatmore|
|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
|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|
CESME, Istituto Zooprofilattico Sperimentale dell’Abruzzo e del Molise ‘G. Caporale’, Via Campo Boario, 64100 Teramo, Italy
Tel: (39-0861) 33.24.05
Fax: (39-0861) 33.22.51
|Contagious bovine pleuropneumonia||Complement fixation test||Dr Ana Rosa Pombo Botelho|
Laboratório Nacional de Investigaçâo Veterinária, Estrada de Benfica 701
1549-011 Lisboa, Portugal
Tel: (+351-21) 711 53 33 / 39 / 40
Fax: (+351-21) 711 52 36
|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
Fax: (49-341) 97.38.219[email protected]
|Equine infectious anaemia||Agar gel immunodiffusion||Dr Stephan Zientara|
UMR 1161 Virologie Afssa/INRA/ENVA, 23 avenue du Général de Gaulle,
94703 Maisosn-Alfort, France
Tel: 33 (0)1 184.108.40.206
Fax: 33 (0)1 220.127.116.11
[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
Tel: 33 (0)3 90.21.41.08;
Fax: 33(0)3. 18.104.22.168;[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) 65.47.53
Fax: (44-1707) 64.67.30
|Equine viral arteritis||Virus neutralisation||Dr Peter J. Timoney|
Maxwell H. Gluck Equine Research Center, Dept of Veterinary Science, University of Kentucky, Lexington, Kentucky 40546-0099, United States of America
Tel: (1-859) 47 57 ext. 81094 ;
Fax: (1-859) 257.85.42;
|Foot and mouth disease||Enzyme-linked immunosorbent assay (antigen and antibody detection);|
|Dr Donald King|
The Pirbright Institute, Ash Road,
Pirbright, Woking, Surrey, GU24 0NF, United Kingdom
Tel: (44-1483) 23.24.41
Fax: (44-1483) 23.24.48
|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) 22.214.171.124
Fax: (55-21) 36.61.90.01
|Infectious bovine rhinotracheitis||Virus neutralisation;|
Enzyme-linked immunosorbent assay
|Dr Eric Dubois|
Anses Sophia-Antipolis, Laboratoire d’Etudes et de Recherches
sur les Ruminants et les Abeilles,
105 routes des Chappes, B.P. 111,
06902 Sophia-Antipolis, France
Tel: 33 (0)4 92.94.37.00
Fax: 33 (0)4 92.94.37.01
[email protected]Dr Eefke Weesendorp
Central Veterinary Institute, part of Wageningen UR, Department of Epidemiology, Crisis Organization and Diagnostics (ECD), P.O. Box 65, 8200 AB Lelystad, The Netherlands
Tel : (31-320) 23.81.02
Fax : (31-320) 23.81.53[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 Genevieve Libeau|
CIRAD/EMVT, Campus international de Baillarguet, Montferriez-sur-Lez, B.P. 5035, 34032 Montpellier Cedex 01, France
Tel: 33 (0)4 67 59 37 98
Fax: 33 (0)4 126.96.36.199
|Rabies||Fluorescent antibody virus neutralisation||Dr Florence CliquetAnses Nancy, Laboratorie de la rage et de la faune sauvage, Technopôle Agricole et Vétérinaire – Bâtiment H, CS 40009, 54220 Malzéville, France|
Tel: 33 (0)3 188.8.131.52
Fax: 33 (0)3 184.108.40.206
|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
Fax: (44-1483) 23.24.48[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: [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 OIE Reference Laboratories to obtain reference materials and get no response, please inform the OIE Scientific Dept.
During the 71st General Session of the OIE 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 OIE and gives a mandate to the Director General of the OIE 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 OIE 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 OIE 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 OIE 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.
Purpose and relevance of the Procedure and of the Register
The aim of the OIE procedure for registration of diagnostic kits is to produce a register of recognised diagnostic kits for OIE Member Countries and for kit manufacturers.
OIE Member Countries need diagnostic kits that are known to be validated according to OIE 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 OIE will be included in detailed form on the OIE web site.
OIE Policy on Transparency, Confidentiality and Disclosure of information
The OIE faces potentially conflicting obligations of ensuring public access to information (transparency) and safeguarding confidentiality of information that the OIE holds in its role as international regulatory organisation (see also the OIE Policy on the Protection of Legitimate Confidentiality available on the OIE website at: https://www.oie.int/en/about-us/key-texts/experts-obligations/).
1. Duty of confidentiality
Within the framework of the OIE Procedure for Registration of Diagnostic Kits, the respect of confidentiality is an essential part of maintaining a good relationship and balance between the OIE, industry and other parties. The OIE 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.
OIE 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.
OIE staff and other individuals involved in the OIE 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 OIE.
Where there is doubt about the management of information, OIE staff members and other individuals involved in the OIE Procedure for Registration of Diagnostic Kits seek guidance from the Director General of the OIE.
2. Continuing duty of confidentiality
Members of the OIE Specialist Commissions, reviewers and staff have a life-long duty of confidentiality even after they have ceased their relationship with the OIE.
OIESRDK (Secrétariat de l’OIE pour l’enregistrement des kits de diagnostic)
Dr Mária Szabó
Secretariat for Registration of Diagnostic Kits
Antimicrobial Resistance and Veterinary Products Department
12 rue de Prony, 75017 Paris
Tel: 33 (0)1 44 15 19 14, Fax: 33 (0)1 42 67 09 87
Email: [email protected]