A16 – Pre- and Post-Market Regulation and Pharmacovigilance Requirements for Prescription Medicines in ASEAN

This session will provide an understanding of the challenges and opportunities for registering and maintaining prescription pharmaceutical products in member states of the Association of South East Asian Nations (ASEAN).  Established in 1967, ASEAN currently includes ten member states and a population of over 620 million people.   In an effort to develop a more comprehensive and harmonised regulatory framework, ASEAN established the Pharmaceutical Product Working Group (PPWG) in 1999.  This session will provide an update of the progress of the PPWG’s harmonisation efforts and compare and contrast ASEAN member state requirements with those of other major regions.  The workshop will provide an overview of pre and post market regulatory requirements and pharmacovigilance reporting throughout the region


Chairperson: Nick Ward, Co-Director, Pharma to MarketSandoz