An Overview of Regulatory Harmonization Initiatives, Regulatory Networks and Collaboration In

1. Pan American Health Organization An Overview of Regulatory Harmonization Initiatives, Regulatory Networks and Collaboration In Latin America and the Caribbean James Fitzgerald (fitzgerj@paho.org) Coordinator, Medicines and Health Technologies PAHO/WHO Washington

2. The Pan American Network for Drug Regulatory Harmonization; Strengthening National Regulatory Authorities for Medicines and Biologicals in the Region of the Americas. Trends in LAC in Regional Cooperation and Collaboration Perspectives for Regulatory Harmonization and Convergence Overview Pan American Health Organization

3. Pan American Network for Drug Regulatory Harmonization: established by the Pan American Health Organization (PAHO) 42nd Directing Council (2000) by Member States (CD42.R11): Promotion of ‘technical agreements on drug regulation among the Member States, including multilateral, bilateral, and subregional agreements, with the participation of all sectors and interest groups’; Prioritization in regulatory harmonization processes; promotion of technical cooperation between NMRAs The components of PANDRH are: The Pan American Conference; The Steering Committee; The technical Working Groups in priority areas; The Secretariat (PAHO). The PANDRH Network in theAmericas Pan American Health Organization

4. PANDRH Governance Pan American Conference Regulators Andean Area CARICOM MERCOSUR SICA NAFTA INDUSTRY Secretariat Steering Committee Consumers Academia Professional Associations WG WG WG WG WG WG Pan American Health Organization

5. PANDRH Guidelines (2000 - 2010) Pan American Health Organization

6. Working Group Documents adopted: Recommendations for the evaluation of similar bio-therapeutic products (SBP); Guidelines to be considered by the Health Authorities in the case of suspected counterfeiting of medicines and medical products; Guidelines for the Registration of Medicines in the Americas; Guidelines for Good Clinical Practices; Guidelines for Clinical Trials in Pediatrics; Considerations on the Use of Placebo; Ethical criteria for the Promotion, Advertising, and Publicity of Medicines. 2011 VI PANDHR Conference Brazil, 2011. Pan American Health Organization

7. Harmonized technical documents developed by the network constitute normative reference for NMRAS in LAC; GLP (Technical Document 6): 21 countries have implemented the guidelines Pharmacovigilance (Technical Document 5): 20 countries have adapted norms based on ‘Documento de las Américas’. Vaccine CTD (Technical Document 1): partial implementation in 14 (of 17 countries investigated) with 7 countries reporting implementation; Technical Guidelines facilitate capacity building and development of Regulatory Networks: GLP: Regional Network of 25 OMCLS from 23 countries; Pharmacovigilance: Network of Focal Points within NMRAs in the Americas (12 countries); Vaccine CTD: guides technical support at country level 2011 Adopt, Adapt and Implement ….. Impact Pan American Health Organization

8. NAFTA MERCOSUR SICA ANDEAN COMMUNITY CARICOM ALBA: ANT, BOL, CUB, DOM, ECU NIC, STV, VEN Increasingly Complex Integration Systems UNASUR APEC BILATERAL &MULTILATERAL AGREEMENTS REGIONAL &INTERREGIONAL AGREEMENTS

9. Strengthening the regulatory capacity of the health authority as part of the essential public health functions. In 2007, Latin American regulators and PAHO identified the need to establish a transparent and uniform methodology to assess the functionality of Regulatory Authorities. In June 2010 during the Executive Committee of PAHO, the Member States requested the issue to be discussed within Directing Council of PAHO. In October 2010, the Directing Council of PAHO held a discussion on the subject and as a result the Member States approved by consensus Resolution CD50.R9 “Strengthening National Regulatory Authorities for Medicines and Biologicals.” Development of Regulatory Capacity to support Regulatory Convergence Pan American Health Organization

10. Strengthening Regulatory Authorities in Medicines and Biologicals (CD50.R9), 2010. To request Member States: a) strengthen and evaluate their regulatory capacity with respect to the functions characteristic of a regulatory agency for medicines and biologicals, through an examination of the performance of their essential functions; b) to support the work of the Pan American Network for Drug Regulatory Harmonization. To Request the Director: • support initiatives for the strengthening and qualification of national regulatory authorities to guarantee the quality, safety, and efficacy of medicines, biologicals,and other health technologies;…… d) promote technical cooperation among country regulatory authorities as well as recognition of the existing capacity in the Region;……

11. Region-wide Commitment to Strengthen Regulatory Capacity Institutional development plans in process for: Costa Rica, Chile, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Panama, Paraguay, Trinidad & Tobago. 5 regulatory authorities in Latin America considered to be National Regulatory Authorities of Regional Reference (PAHO): Argentina, Brazil, Colombia, Cuba, and Mexico; Argentina, Brazil, Colombia, Cuba (2011), Mexico (2012): To share GMP inspection reports, information on product recalls, schedules for inspections; Working towards concession of GMP certificates based on inspections from partner NMRAs.

12. Cooperation and Collaboration in LAC • Increasing bilateral regional agreements (examples); • Brazil (Anvisa);13 bilateral; • Chile (ISP) 4 bilateral; • Mexico (COFEPRIS) 5 bilateral; • Medical Device Inspection Reports (Brazil with US and Canada) • CARICOM / PAHO / US FDA; FOAR (Argentina); strengthening regulatory systems in the Caribbean. • Recognition processes developing; • eg Central America / Union Aduana; • Ecuador, El Salvador: MNRAs of PAHO Regional Reference • ALBA, towards a Regional Center and Single Registry for Medicines Population 2008 (in 000’s) 9.638-1,000 1,000-5,000 5,000-30,000 30,000-100,000 100,000-308,798

13. www/paho.org/prais A regional platform to facilitate convergence processes: • Launched May 2012 by PAHO/WHO, with support from US FDA and Brazil. • Collaborative and secure spaces for NMRAs to work together: • Communities of practice in regulatory capacity development, PANDHR Working Groups; • Indicators presenting characteristics of national regulatory systems in 8 countries (in process); • Projects in development through the platform: • PANDHR Strategic Development Plan 2013 – 2020; • Regulatory Workforce Development (IOM / FDA) • GMP Inspector Network

14. Considerations and Perspectives Regulatory harmonization depends on political, economic and trade agreements as well as policies within regional integration mechanisms; Implementation of harmonized norms requires functional regulatory systems; Promoting NMRA partnerships and regulatory networks to develop joint programs of work (convergence) is achievable in the short-mid term. The use of modern technologies and technology platforms to facilitate regulatory exchange, in secure environments, between regulators on key issues facilitates convergence; The PANDHR Strategic Development Plan (2013 – 2020) will focus on Good Regulatory Practices, development of regulatory networks and regulatory convergence of norms and processes. VII PANDHR Conference to be hosted by Health Canada, 2013.