1. 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

2. 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

3. 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).

4. 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

5. 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”

6. 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

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

8. 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

9. 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

10. RHSC Workplan for
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)

11. 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

12. 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

13. Obrigado! Muchas gracias! Merci! Thank you!