Transcript Catherine Parker - Health Canada

Networking in Regulatory Capacity Building for Vaccines
Catherine Parker: Health Products and Food Branch, Health Canada
New Regulatory Era
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Growing realization that no single regulatory authority has a
monopoly on good science/approaches nor can ‘go it alone’
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Closer regulatory cooperation and ‘networking’ a natural
response to these realities
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Inter-agency and country level agreements/ arrangements in
turn serve as key instruments that help govern enhanced
regulatory interactions
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International Regulatory Cooperation (IRC)
• The use of bilateral or multilateral fora to develop best
practice, share knowledge, adopt or contribute to international
standards, or develop compatible approaches with
international counterparts.
• It can include:
 Information sharing
 Undertaking collaborative scientific work
 Common data collection, risk assessment or compliance
methods
 Joint or parallel review
 Developing common or international standards
 Equivalency or Mutual Recognition
 Harmonization
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International Regulatory Cooperation Approach
Health Product and Food Branch (HPFB) IRC Approach:
1. Develop and strengthen international relations with key
regulatory counterparts and organizations
2. Active collaboration in international standards setting and
harmonization initiatives
3. Strategic engagement with countries with emerging
regulatory systems
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1: Partnership with Key Regulatory Counterparts and
Organizations
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MOUs with key NRAs (e.g. US FDA, EMA)

Under the MOU, Health Canada has bilateral meetings/teleconferences
with US FDA, EMA to further develop collaborative activities and to
explore ways to work more effectively and more efficiently and to
leverage resources (i.e., expertise, funds, training, etc.) through worksharing, such as strategic participation at multilateral fora.
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Participate in EMA committees and/or working parties (e.g. Biosimilars
Working Party, Vaccines Working Party and Biologics Working Party).
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Consortium with HSA, Swiss Medic, TGA
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Meetings of the heads of Medicines Regulatory agencies of Australia,
Singapore and Switzerland take place on an annual basis and
represent a unique opportunity for senior regulators from around the
world to discuss regulatory challenges and develop collaborative
solutions
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2: Collaboration in International Standards Setting and
Harmonization Initiatives
• WHO :

Expert Committee on Biological Standardization of WHO (ECBS)
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WHO Blood Regulators Network (BRN)
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WHO International Conference on Drug Regulatory Authorities (ICDRA)
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WHOCC for Biological Standardization and Evaluation of Biologics
• Pan-American Network for Drug Regulatory Harmonization (PANDRH)
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Biotech Working Group
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Vaccines Working Group
• Laboratory Collaborations:
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NIBSC (National Institute for Biological Standards and Control of the
UK), in the field of blood product and vaccine testing methodology;
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The European Directorate of Quality Medicines (EDQM);
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The FDA’s Center for Biologics Evaluation and Research (CBER);
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China's National Institute for the Control of Pharmaceutical and
Biological Products ( NICPBP) /State Food and Drug Administration
(SFDA).
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3: Strategic Engagement with Countries with Emerging
Regulatory Systems
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HPFB has been involved in several vaccine regulatory capacity building
initiatives including:

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Vaccine and clinical trial regulation training (e.g. India);
Participation in Pan American Network for Drug Regulatory
Harmonization (PANDRH);
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African Vaccines Regulatory Forum (AVAREF);
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Developing Country Vaccine Regulators’ Network (DCVRN); and

Participating in Workshops on International Regulatory Capacity
Enhancement for Influenza Vaccines (WHO and U.S. Department of
Health, and Human Services (HHS)
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Vaccine Regulatory Cooperation & Networking
Canadian HIV Vaccine Initiative (CHVI)
•
July 2010, at the XVIII International AIDS Conference in Vienna, Austria, the
Government of Canada and the Bill & Melinda Gates Foundation renewed their
commitment of up to $139 million to implement the Canadian HIV Vaccine Initiative.
Goals
•
•
•
•
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To advance the basic science of HIV vaccine discovery and social research in
Canada, and low-and-middle-income countries;
To support the translation of basic science discoveries into clinical trials, with a focus
on accelerating clinical trials in humans;
To advance the development of related technologies;
To improve the efficacy and effectiveness of HIV Prevention of Mother-to-Child
(PMTCT) services in low-and-middle-income countries by determining innovative
implementation strategies and programmatic solutions related to enhancing the
accessibility, quality, and uptake of HIV PMTCT services; and
To address the enabling conditions to facilitate regulatory approval and community
preparedness.
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Vaccine Regulatory Cooperation & Networking
Canadian HIV Vaccine Initiative (CHVI)
• CHVI funding has allowed HPFB to play a greater role in addressing
regulatory capacity needs identified by NRAs.
• Some activities include:
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HPFB International Regulatory Forum;
African Vaccines Regulatory Forum (AVAREF);
Training/Information sessions for NRAs provided through participation at vaccine
and clinical trial forums and conferences, such as the WHO Pre-qualification
Process Workshops (Kenya and Burkina Faso), Satellite Symposiums at AIDS
Vaccine Conferences;
CHVI Mentorship Program with the countries of Malawi and Nigeria; and
Development of a road-map for HIV vaccine researchers outlining the vaccine
development process in Canada and internationally.
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Conclusion
Enablers to Effective Cooperation:
• Political and institutional commitment
• Common approaches (e.g. guidance documents)
• Transparency and trust (e.g. bilateral and trilateral telecons.)
• Investment of resources (e.g. HPFB International Regulatory
Forum)
• Mechanics: arrangements (MOUs), virtual networks and secure
information platforms
• Practical, relevant and flexible approaches that result in tangible
benefits (e.g. parallel review with Indian NRA)
• Cooperation at regional and international levels
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Conclusion
Trends and Priorities
• Growing number of regulatory networks
• Expansion and linkages between harmonization initiatives
(harmonizing approaches, not harmonizing regulations)
• Pooling of resources/capacity:
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Work-sharing
Mutual/unilateral recognition (help to make decisions while
respecting context-specific risk management approach)
• Increasing focus on multilateral initiatives
• Inspection and post-market surveillance activities.
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THANK YOU! GRACIAS! MERCI!
Catherine Parker
Biologics and Genetic Therapies Directorate
Health Products and Food Branch, Health Canada
Email: [email protected]
Telephone: (001)613-946-0099
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