Harmonisation of pharmaceutical regulations plays an increasingly important role in eliminating technical barriers to trade without compromising the quality or safety of the medicines. When country-specific regulations apply, additional testing and examination may be necessary before a product can be approved. This lengthens the review period and increases costs, causing delayed patient access to potentially lifesaving drugs. This has led ASEAN to advance harmonization among ASEAN Member States through the development of regional guidelines in reference to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines.
Risk Management Plans (RMP) is a key document developed by ICH that provides information on a medicine’s safety profile. It will allow regulatory authorities to share safety information more effectively and efficiently. In an effort to ensure the adherence to RMP, training workshop at the regional level is required to provide common understanding among ASEAN Member States.
The project aims to leverage the resources and know-how of Japan and ASEAN on the regulatory harmonisation concerning drug products. It will involve Japanese experts in the areas of drug and medical device product regulation through platforms such as the Asia Training Center for Pharmaceutical and Medical Device Regulatory Affairs (PMDA-ATC) managed by Japan’s local regulator.
