1. Implementation of PANDRH Guidelines NAFTA Region VI PANDRH Conference Brasilia, July 2-8, 2011 Justina Molzon -- US Food and Drug Administration Mike Ward -- Health Canada Julio Sanchez y Tepoz -- COFEPRIS

2. NAFTA Position on PANDRH Activities and Guidelines The NAFTA region has been a strong supporter and contributor to the development of PANDRH guidelines, training and other initiatives since the inception of the Network as a means of promoting public health within the Americas The NAFTA region also subscribes to the concepts of “Pan Americanism” and regulatory convergence while respecting regional and country realities COFEPRIS, US FDA and Health Canada conduct teleconferences to establish consensus positions on PANDRH policies, procedures and issues, including discussions on how to make the Norms and Procedures and the governance of the Network more effective 2

3. Adoption of Guidelines: Situation within NAFTA region Regulatory frameworks and programs generally predate PANDRH activities While PANDRH guidelines have not been adopted per se, many of the same principles, practices and requirements are consistent with those of NAFTA regulators by virtue of the adoption of ICH guidelines upon which many of the PANDRH guidelines are based As an example, work of Vaccines Registration WG will be used by Health Canada within its registration framework using the CTD format 3

4. The following areas of work have been undertaken by PANDRH: Good Manufacturing Practices Bioequivalence Good Clinical Practices Pharmacopeia Pharmacovigilance Drug Registration Drug Classification Medical Plants Drug Promotion Good Laboratory Practices Prevention and Combating of Medicines Counterfeiting 4

5. Relevant ICH Guidelines Good Manufacturing Practices for API: Q7 Good Clinical Practices: E6 –E10: Choice of Control Group and Related Issues Clinical Trials –E11: Clinical Investigations of Medicinal Products in the Pediatric Population Registration requirements: ICH Quality, Safety and Efficacy series + CTD/eCTD Pharmacovigilance -- E2 series + MedDRA Interchangeability of Pharmacopoeial Text: Q4B 5

6. Examples of Corresponding Regulatory Frameworks Bioequivalence and Drug Registration –Robust Bioavailability and Bioequivalence systems in respective regulatory frameworks –Well-defined requirements and programs for generic drugs: utilize ICH quality guidelines –Importance of CTD in establishing Good Review Practices and common regulatory language Good Manufacturing Practices –Long established GMP requirements and inspection programs –Health Canada and USFDA members of PIC/S – Agreements (EU, EFTA, Switzerland, Australia) –Worksharing arrangements with TGA, EU on APIs 6

7. Corresponding Regulatory Frameworks (continued) Medical Plants –HC: National Health Products Regulations and program –COFEPRIS: Regulations –FDA Dietary supplements regulations Drug Promotion –FDA Division of Drug Marketing, Advertising, and Communications To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated –HC: Regulations and policies on promotion and advertisting; uses preclearance agencies such as the Pharmaceutical Advertising Advisory Board and Advertising Standards Canada –COFEPRIS regulates advertising Good Laboratory Practices –Both FDA and HC adhere to GLP FDA Good Laboratory Practice for Nonclincal Laboratory Studies HC has Directive for Good Laboratory Practices COFEPRIS implementing OECD standards 7

8. Closing Comments As Pan American regulators we all have way to much to do and not enough resources to do it all We need to work together to make efficient use of the resources we have Working from a common understanding of necessary requirements will promote working together and conservation of resources Ultimate goal is safe, effective and high quality medical products for our citizens 8

9. Obrigada Gracias Thank you Merci