HSA Singapore Revises Drug Master File Submission Process in GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION

With effect from 1 September 2021, applicants are required to submit the HSA’s acknowledgement email on the receipt of the …

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HSA Singapore Introduces an Online Self-Guided Tool for Post-approval Minor Variation Applications

HSA Singapore has launched on 20 August 2021 a new online self-guided tool for post-approval minor variation applications (MIV) to help industry stakeholders …

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Singapore HSA Published Finalised Guidance on the Medical Device Unique Device Identification (UDI) System 

Singapore HSA has published the finalised Guidance on the Medical Device Unique Device Identification (UDI) System on 27 August 2021.   This guidance document …

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Singapore HSA and Malaysia NPRA Launch the HSA-NPRA Generic Medicines Work Sharing Initiative

The Health Sciences Authority (HSA) Singapore and the National Pharmaceutical Regulatory Agency (NPRA) Malaysia have launched the HSA-NPRA Generic Medicines Work …

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HSA Singapore issues new guidance on Consent Requirements for Clinical Trials Involving Collection and Use of Human Tissue

On 1st July 2021 , Health Sciences Authority (HSA) Singapore issued new guidance on Consent Requirements for Clinical Trials Involving Collection and Use of Human Tissue, which will applies …

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Singapore HSA Publishes Regulatory Guideline for 3D-Printed Medical Devices

On 15th July 2021, HSA has finalised the Regulatory Guideline for 3D-printed medical devices. A separate FAQ has been compiled …

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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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