Reflections on International Cooperation VI PANDRH Conference Brasilia, July 2-8, 2011 Mike Ward,Health Canada Julio Sanchez y Tepoz, COFEPRIS Justina Molzon, US FDA NAFTA region

International Cooperation Not an end in itself Should contribute to public health and innovation by strengthening efficiency and effectiveness of regulatory authorities: More informed, timely, transparent decisions Coordinated actions Better use of resources Adoption of best practices, including risk based approaches

Time for Reflection Much effort spent on regulatory harmonization and cooperation, but what have we accomplished to date? Has it been enough? What do we mean by harmonization, convergence and alignment? Will working in regional or even hemispheric blocks address challenges regulators and countries face? Do international harmonization efforts such as ICH and GHTF need to be more inclusive (like PIC/S) Is there a better way of doing things? Mention maturity of ICH (1990), GHTF (1992) and PANDRH (1999).

Observations At an important milestone: growing recognition that progress made to date, while important, not sufficient Current and future challenges driving regulators to consider new paradigms and more effective means of cooperation Common standards, approaches and practicality are sine qua non for effective cooperation Don’t reinvent the wheel: refine, adapt as necessary Recent developments redefining international harmonization efforts: important new opportunities Critical need to think strategically and work more effectively – including between harmonization initiatives

A More Effective Approach Cooperative regulatory efforts should, whenever possible, be directed towards multilateral networks and fora as a means of maximizing investment and impact: “doing things once – collectively” Where this is not possible or appropriate, the efforts of regulatory bodies and international organizations should nonetheless be complementary to extent possible with goal of promoting synergies and avoiding duplication of effort Prerequisites Strategic discussions amongst interested parties (incl WHO) Mapping of bilateral and multilateral interactions and interface with harmonization activities: “connecting all the dots”

One Example: APEC Life Sciences Innovation Forum Unique in that LSIF doesn’t produce harmonized guidances; rather, promotes use of existing international guidelines: Ability to access APEC funds to advance projects Voluntary basis for engagement: ensures participation of those economies interested and committed to cooperation Linkages to international harmonization initiatives: since 2004 sits on the ICH Global Cooperation Group Tripartite structure / complementary roles: government, industry, academia To date, sponsored many workshops on ICH and GHTF guidances

Important Developments June 2009, Seoul, Korea Inauguration of APEC Harmonization Center (AHC) Creation of the Regulatory Harmonization Steering Committee (RHSC)

RHSC Members Regulators from Canada, China, Chinese Taipei, Japan, Republic of Korea, Peru, Thailand and USA with official observers from Mexico and Singapore Industry representatives from drug and medical device sectors Director of APEC Harmonization Center

Regulatory Convergence Proposals for Projects For Medical Products 2020 Pharmaceuticals Medical Devices Multi- Regional Clinical Trials Clinical Evidence Good Review Practices Quality Management System Post-market Surveillance Product Quality Pharmaco-vigilance Projects to support overall strategy and components of Roadmaps ROADMAPS Proposals for Projects

RHSC Workplan for 2011-12 Multi-regional Clinical Trials/Tripartite Initiative Good Review Practices GHTF workshops (2 proposals: Japan, US) Pharmaceutical quality: supply chain integrity ICH Quality by Design [Falsified medical products] Pharmacovigilance Biosimilars Stem cells (prospective harmonization) Pan-Asian Regulatory Conference (IFPMA/DIA/AHC)

Building a Better Harmonization Model Development (Stds, Guidances) Interface Key Enabler: APEC Harmonization Center + RHSC Reg Forum ICH WGs GCG APEC LSIF serves as an enabler of harmonization: Where international standards exist, these standards will be the basis for harmonization Voluntary basis for engagement: ensures participation of those economies interested and committed to cooperation Tripartite structure: government, industry, academia Ability to access seed funds Important new developments: AHC +RHSC Decisions consensus-based APEC Economies and beyond + NRAs: Australia, Brazil, China, Chinese Taipei, India, Korea, Russia, Singapore 11

In Conclusion International regulatory cooperation has become an essential part of dealing effectively with the challenges of an increasingly complex and global environment Cooperation should lead to tangible, meaningful results Despite challenges, some encouraging developments and trends taking place Maximum benefit will come from more strategic discussions, planning and action

Obrigado! Muchas gracias! Merci! Thank you!