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.
For more information please visit News on Training for Experts (Module 3): Mutual Recognition Arrangement (MRA) of Bioequivalence (BE)