Effective and safe drugs are essential to maintaining and improving public health, and it is the responsibility of the world’s regulators to ensure swift access. Therefore, global harmonisation of technical regulatory requirements for drug product approvals and cooperation among regulatory authorities is essential to realise more efficient product reviews and streamlined exchange of critical safety information.
In 2022, the Indonesian FDA, Pharmaceuticals and Medical Devices Agency (PMDA, Japan) and Universitas Indonesia (UI) by the support of Japan-ASEAN Integration Fund (JAIF) conduct a collaboration programme which is called ASEAN-Japan Pharmaceuticals Training in Risk Management Plan. This project aims to advance regulatory harmonisation activities concerning drug products among the ASEAN Member States.