Singapore HSA Extends the Dossier Clarification Supplement For Biologics

HSA introduced the Dossier Clarification Supplement in April 2018 for chemical NDA and GDA to facilitate applicants to leverage the …

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Singapore HSA Launches Innovation Office to Support Product Development 

As part of the aim to facilitate the efficient development and timely registration of beneficial innovative therapeutic products (chemical and …

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Singapore Health Sciences Authority Updates the Guidance for Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products

Singapore Health Sciences Authority has updated the Guidance for Industry: Product Defect Reporting and Recall Procedures for Therapeutic Products  and …

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Singapore Implements New Regulations for Cell, Tissue, and Gene Therapy Products (CTGTP)

Singapore implements new regulations for cell, tissue, and gene therapy products (CTGTP). The regulations take effect from 1 March 2021. …

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CDE of China Issues Guidelines for Drug Information Changes

The Center for Drug Evaluation (CDE) released the “Marketed Chemicals Pharmaceutical Changes Study Technical Guidelines (Trial)”, “Marketed Chemicals and Biological …

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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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