1. 1 Outcome of the 4 th Global Animal Health Conference (GAHC) 24 -25 June 2015 Bettye K. Walters, DVM US Food and Drug Administration bettye.walters@fda.hhs.gov :

2. 2 4 th Global Animal Health Conference (GAHC) June 2015 Dar Es Salaam, Tanzania 101 attendees from 36 countries 100% had their expectations met 96% rated the GAHC as excellent – good 98% rated the GAHC as informative and comprehensive GAHC presentations can be found at www.diaglobal.org 2

3. 3 Guiding Principles human health Harmonization is important because it also impacts food security and human health. Core set of scientific competencies that can lead to the availability of safe, effective and quality veterinary medical products –Reduced animal mortality, disease diagnosis, prevention, and treatment –Increased animal health and production leads to more food production –Increased food production to keep pace with growing population

4. 4 Conference Objectives and Sessions Promote market control Improve market access Promote mutual recognition and the formation of regional organizations Implement African regional harmonization initiatives and discuss local opportunities and challenges towards the implementation of harmonized regulatory systems

5. 5 Session 1: Why is Regulatory Convergence important and what can it facilitate? Regulatory convergence can: expand drug and vaccine development and marketing eliminate obstacles to trade increase access to therapies and vaccines for emerging diseases (60% of which are zoonotic) provide greater certainty in the regulatory process reduce the number animals needed for testing lend greater legitimacy to regulatory decisions 5

6. 6 Session 1: What is needed for Regulatory Convergence to work? Commitment at political and senior management level Shared language Facilities and human resources required for coordination Recognition of the work of other international bodies such as OIE, Codex, VICH, WHO Recognition that convergence of pre- authorisation activities is only one element of an authorization and control system for VMPs

7. 7 Session 2: Market Control EXAMPLE: Malaysia Comprehensive regulatory system in Malaysia that evolved from collaboration through ASEAN The system is complex and has many facets to be comprehensive. The system evolved and is kept current by regular discussion in ASEAN. Need for benchmarking the competencies of regulatory authorities with the aim of building mutual trust

8. 8 Session 2: Market Control EXAMPLE: PANVAC Arose out of the lessons learned from Rinderpest Established a regional laboratory with testing, market controls and training for personnel in other laboratories, manufacturers, and regulators serving many African countries Became an OIE Collaborating Center in 2013 Demonstrated success in providing controls for the quality of vaccines in Africa Demonstrates what is possible through collaboration and support

9. 9 Session 3: Market Access and Mutual Recognition What is needed – industry’s perspective –Predictability of registration process –Reliability – consistent criteria –Simplified process – no repetition / unnecessary administrative burden –Appropriate enforcement mechanisms by authorities –Regional oversight of manufacturing sites –Recognition of and alignment with appropriate international standards in relation to manufacturing and control procedures 9

10. 10 Session 3: Market Access and Mutual Recognition EXAMPLE: GALVmed The value of mutual recognition procedures was noted and realized for veterinary vaccines in East Africa. Has the following advantages: –Accelerates the availability of quality vaccines –Avoids duplication –Improves predictability –Builds trust between regulators –Allows rapid introduction of vaccines against new diseases

11. 11 Session 3: What can hinder or limit Market Access and Mutual Recognition? Limiting factors to market access and mutual recognition –Not respecting WTO rules –Inadequate VMP market control –Lack of harmonization –Lack of acceptance of new technologies –Retroactive action on existing products –Poor control over counterfeit products –Data protection – confidentiality –Lack of visibility of changes in regulatory environment –Unreasonable registration costs 11

12. 12 Session 4: Regional Organizations What can Regional Organizations provide? –Harmonization - harmonized technical requirements in line with intergovernmental standards –Flexibility - organizational and procedural - for marketing authorizations –Adaptability - regional solutions that can be adapted to local situations Examples – VICH, EU, South African, Asian, South American, US-Canada models

13. 13 Session 4: What is needed for Regional Organizations to work? Characteristics, Benefits and Needs of Regional Organizations –Need for technical and regulatory commitment –Legal basis for mutual recognition –Structure to bring regulators and industry together on a regular basis –Time to build trusting and sustainable relationships –Confidentiality and transparency –Networking –Inclusivity of process –Common language

14. 14 Breakout Sessions KEY THEMES common across Sessions Must have political will among government departments Must have good governance May need capacity building Need adequate resources Communication is a must Trust among regulators and industry

15. 15 Breakout Sessions KEY THEMES common across Sessions Need for strengthening professional organizations and ethical standards Improved marketing infrastructure Ensure confidentiality of data Build capacity of leaders in the field, end users, professionals Human and veterinary single agencies should work together so not to compete for resources 15

16. 16 Breakout Sessions KEY THEMES common across Sessions International norms are advantageous - with caveats Regular joint review of guidelines Convergence offers potential for Increased pharmacovigilance Increased monitoring of resistance Increased access to products

17. 17 Breakout Sessions KEY THEMES common across Sessions What are some perceived potential disadvantages of regulatory convergence? –Loss of flexibility to make local decisions and standards –Loss of market to local industry –Need time to develop processes –Capacity building requires financial, IT, and training resources 17

18. 18 Pre-Conference VICH Workshop June 24, 2015 Introduction to VICH Role of VICH Guidelines in the product registration process Introduction to VICH Outreach Forum How to get involved in VICH How to get more information www.DIAglobal.org 18

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