Transcript Implementation of PANDRH Guidelines

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
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
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
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
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
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
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
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
Obrigada
Gracias
Thank you
Merci