HSA Singapore Issues Updated Version of Regulatory Requirements For Clinical Trial New Applications And Subsequent Submissions

The new version Rev. No. 004 , issued on 28 April 2021, clarified on regulatory requirements for clinical trials of controlled drugs or psychotropic substances.   …

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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 Finalises Guidance On Electronic Labelling Of Therapeutic Products

HSA, in consultation with industry stakeholders, launched an e-labelling pilot trial for therapeutic products (TP) in August 2019.  The objective …

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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 HSA Introduced New Self-Help Tool for Grouping of Medical Devices

On 25th February 2021, the Medical Devices Branch (MDB) has introduced a new self-help tool to guide in grouping of medical devices for …

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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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Australia TGA Published Regulatory Changes for Software Based Medical Devices

Australia TGA published a summary of regulatory changes to the regulation of software-based medical devices (including software as a medical …

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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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Singapore HSA Streamlines Stability Data Requirements for Therapeutic Product Registration

Singapore HSA has revised the Guidance on Therapeutic Product Registration in Singapore and Related Appendices. The changes will take effect …

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