Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia

Ensuring access to essential medicines is a key objective of all health systems, and is an integral component of the progress towards universal health coverage (UHC). Despite global and national efforts to improve access and affordability of medicines, millions of people – particularly in low- an...

Full description

Bibliographic Details
Main Authors: Teo, Hui Sin, Foerg-Wimmer, Christina, Chew, Pei-Lyn Melissa
Format: Report
Language:English
en_US
Published: World Bank, Washington, DC 2017
Subjects:
R&D
PDF
IP
Online Access:http://documents.worldbank.org/curated/en/727671496171008743/Medicines-regulatory-systems-and-scope-for-regulatory-harmonization-in-Southeast-Asia
http://hdl.handle.net/10986/26801
Description
Summary:Ensuring access to essential medicines is a key objective of all health systems, and is an integral component of the progress towards universal health coverage (UHC). Despite global and national efforts to improve access and affordability of medicines, millions of people – particularly in low- and middle-income countries – still remain without access to quality-assured and affordable medicines. This study aims to contribute to existing knowledge on regulatory systems and harmonization efforts in Southeast Asia. Focusing on five member states of the Association of Southeast Asian Nations (ASEAN) – Indonesia, Malaysia, the Philippines, Thailand, an Vietnam – this study gives an overview of pharmaceutical markets and key pharmaceutical policies in the region, provides a cross-country comparison of medicines regulatory systems, and details harmonization efforts, opportunities, and challenges.