VICH :To a wider international harmonisation of registration requirements

Transcription

1 VICH :To a wider international harmonisation of registration requirements Hirotaka Makie, D.V.M., M.S. Animal Products Safety Division, Food Safety and Consumer Affairs Bureau, MAFF, Japan OIE Regional Workshop (Tokyo, Japan, 3 March 2011)

2 Presentation Outline What is VICH? (Introduction to VICH) OIE 5 th Strategy ( ) VICH Strategy III ( )

3 What is VICH? VICH is a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration. Its full title is the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. VICH was officially launched in April 1996.

4 New Zealand VICH = International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products Canada Europe VICH member VICH observer USA Japan Australia

5 VICH Objectives Brings together Regulatory Authorities and Industry Aim: greater harmonisation of requirements for veterinary product registration Reduced/eliminated need for duplicate testing More efficient use of human, animal and material resources while safeguarding quality, safety & efficacy Reduction of unnecessary delays in global product development Provide a basis for widening international harmonisation of registration requirements

6 VICH Milestones 1991 Creation of ICH with 1 st conference th ITCVDR conference in Argentina: concept of VICH 1994 OIE ad hoc group: scope, membership and objectives of VICH April 1996 Nov Oct st VICH Steering Committee at the OIE Offices in Paris VICH begins work 1 st VICH Public Conference in Brussels (Belgium) 2nd VICH Public Conference and 11 th Steering Committee meeting in Tokyo (Japan) Oct Adoption of the VICH Strategy for May 2005 June 2008 June rd VICH Public Conference and 16 th Steering Committee meeting in Washington DC (USA) First reflection on Global Outreach 4 th VICH Public Conference, 24th Steering Committee and plenary exchange on Global Outreach Strategy in the OIE Offices in Paris (Europe)

7 VICH Steering Committee EU: Japan: USA: Regulatory Representatives: EMA + European Commission JMAFF FDA-CVM + USDA-CVB Representatives from Industry Associations: IFAH-Europe JVPA AHI, AVBC ANZ: Canada: AVPMA + NZFSA HC-VDD + CFIA-VBS Animal Health Alliance, AGCARM CAHI OIE - Associate Member Secretariat: IFAH

8 VICH Expert Working Group Current Quality Safety Metabolism and Residue Kinetics Microbiological ADI Quality of Biologicals Finish Pharmacovigilance Antimicrobial Resistance Target Animal Safety Good Clinical Practices Anthelmintics Efficacy Ecotoxicology

9 The VICH process: 9-step procedure Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Steps 7-8 Step 9 Concept paper to propose issue Review by SC Appointment of Topic Leader/Chairman EWG to produce draft Guideline SC to review draft Guideline Public consultation in the regions/countries EWG to review comments SC to adopt final Guideline Implementation of Guideline Recommendation for review 9-step procedure

10 Achievements [June 2010] 40 finalised guidelines (GLs): Implemented: 37 For implementation in 2010 & 2011: 3 New GLs under consultation/discussion: 11 Revised GLs at Step 9 Implemented: 5 Under review: 2

11 The 5 th OIE strategic plan: 2011/2015 OIE Core Mandate: The improvement of animal health, veterinary public health and animal welfare worldwide, including: -Food security - The One Health concept for the reduction of risks of high-impact diseases at the animalhuman-ecosystems interface - The relationship between animal production and the environment

12 OIE strategy for veterinary products: concluding remarks OIE Fifth Strategic Plan mentions explicitly the need to: Develop and update standards, guidelines and recommendations on diagnostic tests, vaccines and veterinary drugs, including antimicrobials. Promote the use of OIE-recognised assays and diagnostic kits by both the public and the private sectors.

13 OIE strategy for veterinary products: concluding remarks (cont d) Strengthen collaboration with relevant international and regional organisations on technical and legal issues related to veterinary products, including legislation, registration, control and monitoring of use. VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) CODEX (Committee on Residues of Veterinary Drugs and the Intergovernmental Task Force on Antimicrobial Resistance).

14 VICH Strategy Phase III ( ) Developing new technical guidelines Maintaining and updating existing guidelines and monitoring their consistent implementation VICH Global Outreach: provide a basis for wider international harmonisation of registration requirements

15 Future opportunities: VICH Global Outreach Information and communication about the role of VICH in relation to OIE, CODEX managing expectations Global regulatory governance of veterinary medicinal products to be progressed by OIE reference to VICH guidelines as a final step VICH to establish mechanisms to collect needs and expectations from non-vich countries and to integrate them into the process (guidelines & governance)

16 Future opportunities: Putting them into reality Continuing to actively support OIE in its endeavours to improve the global governance of veterinary medicines coordinate both strategies Global needs of the future: continued dialogue with global organisations

17 Reference 1. Boenish B.: Presentation at the 4 th VICH Conference, June Dehaumont P.: Presentation at the 4 th VICH Conference, June Marion H.: Presentation at the 4 th VICH Conference, June VICH Public Website:

18 Thank you for your attention. More information on VICH & Final and Draft Guidelines available at: