Promoting cooperation for regulation in trade of medical products: Report of the regional meeting, WHO-SEARO, New Delhi, India 22-24 September 2015
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AbstractCooperation among Member States is becoming increasingly important due to the complexity of medical products (pharmaceuticals, biologicals, vaccines, diagnostics and medical devices), globalization, supply chains, and growing public expectations. Access to medical products is influenced by regulatory requirements at national and international levels. The member states in South East Asia region recognize each country is evolving, developing and strengthening their regulatory mechanisms to provide quality pharmaceutical products to achieve the goal of Universal Health Coverage based on national norms and public health needs. During "Regional Meeting for Promoting Cooperation for Regulation in Trade of Medical Products" at WHO-SEARO, New Delhi, India 22 to 24 September 2015, the member states felt there is an immediate need to develop a regulatory affairs network for cooperation as most of the countries in the region have limited resources. A Regional regulatory network will create a platform for enabling cooperation and support for quality, safe and efficacious medical products in a timely and efficient manner. Formation of similar regional networks, sometimes defined by economic or political frameworks, is common in many other regions of the world such as the Americas, Africa, the Gulf, Asia-Pacific (APEC), ASEAN region and the European Union. The representatives at the Regional Meeting supported establishing a network to enhance information exchange and capacity building with a view to encouraging the adoption of international standards, best practices and effective use of regulatory resources. They noted a number of areas of potential collaboration as part of a pragmatic, step-wise approach. Participants supported the idea of convening an annual meeting with a focus on matters that relate to the mandates of National Medicines Regulatory Authorities as a first step in exploring mechanisms and areas of enhanced cooperation as a matter of public health priority.
Regional Office for South-East Asia, World Health Organization. (2016). Promoting cooperation for regulation in trade of medical products: Report of the regional meeting, WHO-SEARO, New Delhi, India 22-24 September 2015. WHO Regional Office for South-East Asia. https://apps.who.int/iris/handle/10665/251517