First Workshop for National Regulatory Authority for Vaccines in Western Pacific Region
9-11 November 2011 - The Western Pacific Regional Office organized the first workshop for National Regulatory Authority (NRA) for vaccines in Seoul, Republic of Korea from 9-11 November 2011. The Korean Food and Drug Administration (KFDA) was co-organizer of this workshop. Participants from 11 countries including observer from donors and technical cooperation agencies attended the Workshop. The objectives of the workshop were to identify lessons learnt and best practices on strengthening medicine regulatory system in the area of vaccines with focus on developing country action plans of regulatory systems to ease introduction of new vaccines and respond to challenging needs around quality, safety and efficacy of vaccines used in national immunization programmes. The workshop also aimed to discuss the concept of a regional alliance that can use WHO as main convener of this initiative to strengthen regional, interregional and inter-country collaboration among National Regulatory Authorities.
The workshop was designed to review country situation in the area of vaccine regulation, to discuss in plenary and working group session the gaps and strengths of the various country systems as well as to use existing global best practices documented with the help of WHO HQ. One of the main outcome was that 8 countries had been able either to review or develop their NRA Institutional Development Plan (IDP) and all participants agreed on the way forward to launch the regional alliance to build capacity in the WPR member states. Three countries like Australia, China, and Korea shared their best practices, expertise's in regulatory field and support plan for non functional NRAs. Next steps will be to develop a concept paper within one month and an action plan using a designated drafting group including Australia, China, South Korea and Japan then to submit it for discussion and endorsement by early 2012.