ASEAN Regional Integration Support from the EU

Training for Experts (Module 3): Mutual Recognition Arrangements (MRA) of Bioequivalence (BE) Study Reports of Generic Medicinal Products

ARISE Plus has been assisting the ASEAN Pharmaceutical Product Working Group (PPWG) in its efforts to facilitate intra ASEAN trade in Generic Medicinal Products.

Approval of generic medical products requires a technical study on the candidate product to be conducted by a qualified BE Centre before approval is granted by the regulatory agency. Such BE studies are technically demanding and evaluation of the BE Centre requires specialized skills and knowledge. A series of 3 training modules for prequalified ASEAN Experts were planned and partnered with ASEAN. The first course was supported by ARISE Plus and held in March 2021, with trainers who were ARISE Plus Experts. 

The current training module delivered on 1-3 September 2021 is the second module and focused on training the selected experts on the procedures for conducting inspections and evaluation of BE Centers.  Malaysian experts from the National Pharmaceutical Regulatory Agency (NPRA), undertook the development of the training materials and delivered the training. This training module was successfully completed with all the 20 identified experts and a number of observers from Member States. ARISE Plus experts are now developing the final module that will include on-site practical training and mock inspections at selected ASEAN BE Centres. The third module is planned to be delivered in early 2022.

Upon completion of the 3 training modules, the panel of experts will be qualified to inspect and evaluate and certify BE Centers. meet the agreed standard. This will avoid unnecessary duplication of very costly studies and make generic medicines more readily available in ASEAN, thus benefiting consumers. ASEAN pharmaceutical regulators will benefit by enabling faster approvals and ASEAN drug manufacturers will have a wider market access and significant cost savings.

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