Animal health products (also known as veterinary products ) includes veterinary drugs, vaccines, antibody products, and diagnostic tests.

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2 Animal health products (also known as veterinary products ) includes veterinary drugs, vaccines, antibody products, and diagnostic tests.

3 The process results from the gradual adoption of internationally recognized technical guideline documents, standards and scientific principles, common or similar practices and procedures, or the establishment of appropriate domestic regulatory mechanisms that align with shared principles to achieve a common public health goal. Sources: World Health Organization publications Regulatory harmonization. Geneva: World Health Organization; WHO Drug Information. Available at: Harmonization.pdf?ua=1 Good regulatory practices: guidelines for national regulatory authorities for medical products. World Health Organisation. Draft for comment. October 2016 Available at: racticespublicconsult.pdf?ua=1 Session 2.2

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5 Stakeholders include regulatory agencies, manufacturers, importer-distributors, veterinarians, animal owners, and the public.

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8 The OIE encourages convergence of regulations and technical standards for animal health products, and contributes to the successful adoption and implementation of global or regional convergence initiatives, among its 180 member countries through: OIE contributes through its standard-setting role, veterinary services initiatives, scientific and technical information, quality standards, and extensive networks: OIE: - Delegates, Focal Points for Veterinary Products - Collaborating Centres, Reference Laboratories - Specialist Commissions, and ad hoc Groups. Participation in government/industry harmonization fora, such as VICH Outreach Forum, HealthforAnimals Global Animal Health Workshops and Conferences, CAMEVET Seminars. Links with funding agencies and collaborative groups that promote regulatory convergence, harmonization, capacity building, and coordination of animal health research and development, e.g. BMGF, GALVmed, STAR-IDAZ. Links and partnerships with regional or international harmonization bodies, industry associations, and non-government organizations. OIE Evaluation of Performance of Veterinary Services (PVS) for animal health programs of Member Countries. Session 2.2

9 4 th Global Animal Health Conference, Theme: Regulatory Convergence, June 2015, Dar Es Salaam, Tanzania, Press Release: Global Animal Health Conference Addresses Regulatory Barriers 24/06/2015 Conference report available on HealthforAnimals website: 5th Global Animal Health Workshop and Conference Improved Market Access for Authorized Veterinary Medicines, the Asian Perspective, November 2016, New Delhi, India. Conference report available on HealthforAnimals website: Animal-Health-Conference-2016_Conference-Report-FINAL Session 2.2

10 VICH Outreach Forum: Provides a basis for broader international participation, beyond the original VICH members and observer countries. Currently includes 17 countries (e.g. Morocco, South Africa, Uganda, plus other recent applicants) as well as international or regional organisations (e.g. OIE, UEMOA, CAMEVET, and ASEAN), and growing. Encourages reference to VICH Guidelines in national registration systems. Meets together with the VICH Steering Committee every 9 months; meeting venue is rotated around the VICH member countries *VICH = International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products Session 2.2

11 Source: WHO Drug Information Vol. 28, No. 3, 2014 Regulatory harmonization: 16th International Conference of Drug Regulatory Authorities (ICDRA) Plenary 5 Available at:

12 Source: World Health Organization (WHO) DRAFT Good regulatory practices: guidelines for national regulatory authorities for medical products Working document QAS/ October 2016 Draft for comment Prepared by EMP/RSS WHO/DRAFT/ October ENGLISH ONLY Draft available online at: t.pdf?ua=1 This document has been prepared for the purpose of inviting comments and suggestions on the proposals contained therein, which will then be considered by the Expert Committee on Biological Standardization (ECBS) and the Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP). The outcome of the deliberations of the Expert Committees will be published in the WHO Technical Report Series. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and member organizations) without the permission of the World Health Organization. The draft should not be displayed on any website. The draft GRP guideline defines regulatory convergence and encourages the use of reliance on the work of other national regulatory authorities and standard-setting bodies, through incorporation by reference, collaboration, and cooperation. Session 2.2

13 Convergence Measures: Can be implemented in many forms - unilaterally, bilaterally, multilaterally (regions or sectors), or globally. Can be applied at any stage, regardless of the current level of harmonisation or official recognition of equivalence among partners. Activities can be prioritized/targeted to focus on key elements (sectors, products, or trading partners). Specific convergence measures be implemented on their own, in a step-wise manner, or as a component of broader harmonisation initiatives. Session 2.2

14 Different regulatory pathways: Full review Expedited procedures. National Regulatory Authority (NRA) of procuring countries are encouraged to adopt Recognition of decision of a competent NRA Review decision of NRA of producing country or another competent NRA Partial review and evaluation of supporting data The responsibility of the final regulatory decision on the approval of the change still lies with the receiving NRA. From: WHO standards for regulatory evaluation of vaccines and biotherapeutic products current status and way forward Dr Ivana Knezevic, WHO/HIS/EMP/TSN/NSB 25 January 2017 Washington DC _KnezevicIvana.pdf National regulatory authorities could clarify the prerogative of their regulatory officials to take preceding approvals or pertinent regulatory controls administered by counterparts in other countries into consideration, when reviewing and approving licensing submissions, and implementing post-licensing regulatory controls. Session 2.2

15 Communauté économique des États de l'afrique de l'ouest (UEMOA) West African Economic and Monetary Union Members are Benin, Burkina Faso, Guinea-Bissau, Ivory Coast, Mali, Niger, Senegal, Togo East African Community (EAC) Members are Burundi, Kenya, Rwanda, Tanzania and Uganda African Medicines Registration Harmonization (MRH) Project Southern African Development Community (SADC) Members are Angola, Botswana, Democratic Republic of Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, United Republic of Tanzania, Zambia, Zimbabwe Session 2.2

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18 Global convergence of regulations, quality standards, and document requirements for animal health products could: streamline regulatory approval processes to improve their availability, without diminishing the overall regulatory controls that are required to safeguard their quality, safety, and efficacy. Session 2.2

19 National regulatory agencies should: Strive to adopt common technical standards and document requirements, consistent with international standards. Streamline administrative processes and avoid duplication, when reviewing and approving licensing submissions, regulatory officials should take into consideration the preceding approvals and ongoing regulatory oversight in other jurisdictions. Internationally accepted regulatory standards could be incorporated by reference in national regulations or guidelines. Session 2.2

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