Role of regulatory agency in vaccine safety 2010

The Development of Regulatory Authorities and of the Process of Post Marketing Surveillance in developing countries Vaccination is a very powerful public health tool for preventing many infectious diseases. The protection obtained in vaccination programs can be measured both at individual level and community level. As for drugs, the vaccines need to be registered and licensed by regulatory and health authorities before vaccination recommendations. The evaluation of the vaccine to be licensed is focusing on 4 major aspects: quality, efficacy, safety and post-marketing surveillance. As the last item is implemented since several years in the Western Countries, the Developing Countries are still working on better pharmacovigilance systems. Recently risk management plans have been implemented both in Europe and North America, significantly increasing the safety activities in a pro-active manner.

Manufacturers have to meet the requirements set by regulatory agencies for both registration of vaccines and post-marketing surveillance. Although most developed countries have a national regulatory authority, with two forefront agencies (EMEA for EU countries and FDA for the USA), important differences exist between different regions of the world regarding the requirements for registration of vaccines and pharmaco-vigilance. Developing countries have a broad range of regulations regarding both the registration and the pharmaco-vigilance systems.

The objective of this meeting is to bring together experts from the regulatory agencies, the vaccines manufacturers and vaccines program (EPI) from both Developed and Low to Middle Income Countries (LMIC), aiming at:

• Reviewing[n1] the present status on the role of regulatory agencies in relation to the benefit-risk ratio of vaccines (clinical trials and pharmaco-vigilance) in both western and low to middle income countries; with a discussion on how vaccines are evaluated on the different parts of the dossier: Quality, Non-Clinical, Efficacy, Safety and Risk Management Plan.
  
• Discussing the response of vaccine manufacturers to increasing demands of regulatory agencies in terms of vaccines safety and effectiveness. Indeed once a vaccine is licensed, it is extremely important to measure and follow how the vaccine will behave in real world conditions.
  
• Reviewing the international and regional actions for developing/strengthening regulatory authorities in Low to Middle Income Countries and the involvement of the WHO, western regulatory agencies and the manufacturers.
  
• Trying to identify the gaps in the regulatory systems in low to middle income countries.
  
• Trying to identify further actions to be taken to help filling these gaps.