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Date Posted	News Title
2021/09/23	Australia: TGA publishes document on refinements to the personalised medical device framework
2021/09/22	US: FDA finalizes more Q&As on biosimilar development
2021/09/17	R&D: FDA-EMA parallel scientific advice pilot program for complex generic/hybrid products
2021/09/16	Europe: EMA study reveals need for RWE framework, submission structure
2021/09/15	Asia: PMDA shares the experiences of Japan’s amended medical device rules
2021/09/14	Asia: HSA Singapore introduces an online self-guided tool for post-approval minor variation applications
2021/09/13	Europe: HMA-EMA plans real-world metadata framework for regulatory decision-making
2021/09/10	【一週國際法規新聞】2021 年09月06日 ~ 09月10日
2021/09/10	Europe: EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty
2021/09/09	Training: WHO virtual cGMP training marathon for vaccine manufacturing