China Revises the Provisions for Lot Release of Biological Products

Pursuant to the new Vaccine Administration Law and the revised Drug Administration Law, the Provisions for Lot Release of Biological …

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South Korea MFDS issues 3 Q&As relating to GMP, Official Communication Channel , Drug Approvals and other topics

South Korea Ministry of Food and Drug Safety (MFDS) has issued 3 Q&As in late-November/early-December 2020 relating to GMP, Official …

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USA, FDA’s launch of purple book, an online database for biologics

The US Food and Drug Administration launched the first version of the Purple Book, which is a searchable online database …

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World Health Organization first bio-similar pre-qualification

WHO (World Health Organization), pre qualified their first bio-similar. This newly pre qualified medicine is Samsung Bioepis’ Ontruzant which is …

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