The adoption of the ASEAN Pharmaceutical Regulatory Policy (APRP) by the ASEAN Economic Ministers and ASEAN Health Ministers, in 2022, marks a significant milestone in ASEAN’s ambitious goals of integrating the market for pharmaceutical products and for ensuring timely access to high quality, safe and efficacious pharmaceutical products and ultimately protect the health of the ASEAN people. The APRP sets the foundation for enhanced harmonisation of regulatory requirements, deepening the collaboration between ASEAN’s national regulators, and creating an enabling environment for innovation, investment, and trade in the pharmaceutical sector.

Pharmaceutical priorities are shared responsibilities of different stakeholders and national line agencies. For many years, the Economic and Health Sectors have made significant progress in integrating the ASEAN pharmaceutical sector through initiatives to improve access to medicines, harmonise technical requirements and promote mutual recognition of inspections and reports for pharmaceuticals. Nevertheless, there is a wide spectrum of areas where further collaboration would be desirable from both the economic and healthcare perspectives.