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Many believe that it is convenient and safe for developing country national regulatory authorities (NRAs) to license or register new vaccines, based on previous assessments made by a developed country regulatory agency. According to this “pragmatic” approach, the world is divided into those who know how to do an assessment of the quality, efficacy and safety of a new vaccine, and those who do not, and it is implied that it is simply not worthwhile for the latter to try to repeat what the former has already done, because it would be expensive, time consuming, and would possibly not be feasible for them. In other words, it would be an inefficient duplication of efforts. By the same token, developing country NRAs should not waste time assessing the scientific merit of clinical trial protocols, and should limit themselves to evaluating such protocols from an ethical perspective. As a counter argument, it can be claimed that the world has now entered a new era whereby new vaccines are being developed that target diseases which only occur or are more prevalent in developing countries. Thus, clinical trials of these vaccines are being or will be conducted in developing countries, and some of these products will be first licensed/registered in the same countries. Moreover, licenses of “old” vaccines that are still used in the developing world will not be renewed by some NRAs from developed countries, as is the case for the European Medicines Agency (EMEA), for example. Finally, manufacturers from some developing countries have acquired technologies transferred from developed country counterparts, and are developing new products such as vaccine combinations that have to be assessed by clinical trials before being submitted for licensure/registration. Therefore, at least the more advanced NRAs from developing countries now need to know how to analyze (phase I, II and III) clinical trial protocols, follow up at least the clinical trials conducted in their territories through good clinical practice (GCP) inspections and adverse event reporting, assess data from these clinical trials as evidence for licensure/registration, and do post marketing surveillance of these products. Brazil, represented by the Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency – ANVISA), the Brazilian drug regulatory agency, has, in recent years, been involved in World Health Organization ( WHO) and Pan American Health Organization (PAHO) initiatives aimed at improving international cooperation between NRAs in the field of vaccines. There follows a brief summary of this involvement and some personal reflections. In September 2004, the Developing Countries’ Vaccine Regulators Network (DCVRN), an initiative from WHO, was launched after over two years of preparation 1,2. The original idea was for the establishment of an NRA network of developing countries aimed at promoting the strengthening of the procedures for evaluating clinical trial proposals and clinical data. Nine countries (Brazil, China, Cuba, India, Indonesia, Korea, Russia, South Africa and Thailand) fulfilled the eligibility criteria of having WHO pre-qualified vaccine manufacturers, of being fully functional NRAs (i.e. meeting six critical regulatory functions or having a government endorsed workplan with timelines to achieve this), of having domestic expertise in research on new vaccines and recognized medical institutions for clinical research on the control of infectious diseases, and of being likely to be the first to trial and license/register new vaccines. Representatives from these countries have met six times since then, and other than organizing the network structure and regulations, have participated several scientific sessions for discussing a series of vaccines (e.g. rotavirus, tuberculosis, HIV, HPV, Japanese encephalitis), in some occasions with the joint participation of representatives from more developed (FDA) and less developed agencies. From 2003 PAHO has organized a series of regional meetings involving countries from Latin America in order to make an inventory and better understand the clinical trial evaluation processes in different countries from that region, to develop capacity building activities, and to discuss a novel rotavirus vaccine that was to be introduced in the region for the first time worldwide. In 2005 a working group

Cooperation between regulatory authorities from developing countries in the evaluation of vaccine clinical trials