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Progressive Licensing Project

Pharmaceutical Quality Workshop

June 28, 2007

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Discussion Topic 4:
Quality implications of the increasingly international dimension of the pharmaceutical industry

Objectives:

The purpose of this paper is to examine the opportunities and challenges associated with the regulation of an increasingly globalized pharmaceutical manufacturing industry.

Summary:

This topic touches on two of the guiding themes of the Progressive Licensing Project: good planning and accountability.

International trends and developments serve as both drivers and enablers of a new regulatory model of pharmaceutical quality. Outsourcing and growing shifts in supplies of active pharmaceutical ingredients (APIs) and drug products from non-ICH regions, in particular India and China , are creating increased challenges.

Canada is already an active participant in global drug regulations through its involvement in international organizations such as International Conference on Harmonisation (ICH), Pharmaceutical Inspection Co-operation Scheme (PIC/s), European Directorate for the Quality of Medicines (EDQM), World Health Organization (WHO), and its Mutual Recognition Agreement (MRA) relationship and other cooperative arrangements. Reliance on meaningful cooperation between regulatory counterparts and international organizations (Pharmacopoeia, WHO) will be necessary to address current and future challenges. The challenges will be how and where to best invest resources as part of a more strategic approach that will most contribute to achieving high quality drug products.

Questions/issues:

1. How can international regulatory cooperation contribute to the better management of risk and the strengthening of the regulatory capacity and performance in the arena of pharmaceutical quality?
   
   
2. What are the greatest opportunities and challenges for effective international regulatory cooperation?
   
   
3. What factors should be taken into account in moving towards a more internationally-based model of pharmaceutical drug regulation?
   
   
4. What role should capacity-building and cooperation with emerging countries play in helping mitigate risk associated with the international movement of drugs and drug products?
   
   
5. Do you consider that regulatory considerations can be developed with non-regulatory authorities (such as Pharmacopoeia, WHO)?
   
   
6. What kind of regulatory arrangements / agreements should be developed to address these issues?