The development of regulatory authorities and process of post marketing surveillance in developing countries

April 23, 2010 - Les Pensières, Annecy (France)


This seminar held in Les Pensières, 29–31 March, gathered invited experts from the WHO, several National Regulatory Authorities (NRAs), non-governmental organizations and agencies, as well as expert representatives from several vaccine manufacturing organizations.

The focus points of the meeting were: the mechanisms for assessing the safety, in use, of licenced vaccines particularly in vulnerable populations of public health programs, and the potential for enhancements of these. Vaccines are powerful public health interventions, but their nature as biological medicines and their wide-spread use in infants, and other vulnerable populations, means that their use will be associated with adverse events.

Assessing the contribution of the vaccine to these events is challenging.

As a result, manufacturers and NRAs have adopted a range of post-marketing activities to detect and assess the incidence, causality and impact of vaccine adverse events following the introduction of a new vaccine, including in relevant population groups.

The meeting considered the range and impact of known adverse events and their role in shaping the evolution of current post marketing surveillance expectations; the assessments of vaccine safety conducted during the clinical development and licensure of a vaccine; and current surveillance activities in the EU and USA. Three presentations of national postmarketing surveillance activities were scheduled from representative middle-income countries, but only that of South Africa was presented due to unforeseen circumstances. Representatives from two manufacturers explained the activities undertaken by their companies to collect, assess and report adverse events following immunization (AEFI) to support NRA activities.

It is necessary for regulatory authorities to devote resources to collection and evaluation of AEFIs to support continued vaccine licensure. The importance of manufacturers’ activities in risk management and pharmacovigilance is recognized. Supply and donor agencies can contribute to this. Development of information sharing and common procedures for reporting, collating and analyzing adverse event reports are in progress.

Regulatory actions must be based on sound scientific information.

Discussions highlighted the absolute need for excellent communications between the components of the vaccine delivery system, including manufacturers, regulators, WHO, procurement agencies and vaccine program administrators including the clinic personnel.

For more information contact:
Catherine Dutel

Conference Manager
Tel: +33 (0)4 72 40 79 46
E-mail: Send an e-mail