Promoting cooperation for regulation in trade of medical products

Overview

Cooperation 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 both national and international levels.

Member States in the South-East Asia Region recognize that each country is evolving, developing, and strengthening its regulatory mechanisms to ensure the availability of quality pharmaceutical products, in alignment with national norms and public health needs, to achieve the goal of Universal Health Coverage.

During the Regional Meeting for Promoting Cooperation for Regulation in Trade of Medical Products, held at WHO-SEARO, New Delhi, India, from 22 to 24 September 2015, Member States expressed the urgent need to develop a Regulatory Affairs Network for cooperation, as most countries in the region have limited resources. A Regional Regulatory Network would provide a platform for enabling cooperation and support for quality, safe, and efficacious medical products in a timely and efficient manner.

The formation of similar regional networks—often defined by economic or political frameworks—is already common in many other regions of the world, such as the Americas, Africa, the Gulf, Asia-Pacific (APEC), the ASEAN region, and the European Union.

The representatives at the Regional Meeting supported the establishment of such a network to enhance information exchange and capacity building, with the aim of promoting the adoption of international standards, best practices, and effective use of regulatory resources. They identified several areas of potential collaboration as part of a pragmatic, step-wise approach.

Participants supported the idea of convening an annual meeting focused on matters relating to the mandates of National Medicines Regulatory Authorities as an initial step in exploring mechanisms and areas of enhanced cooperation, recognizing this as a matter of public health priority.