China Issues New Pharmacovigilance Quality Management Practice/Standards

On 7th May 2021, China’s National Medical Products Administration issued a new Pharmacovigilance Quality Management Practice/Standards (ie. China GvP) to …

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China NMPA Establishes Patent Linkage Registration Platform

On May 18, 2021, China’s Center for Drug Evaluation of National Medical Products Administration (NMPA) issued the “Notice on the public testing …

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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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Thai FDA Announces Extension of Validity Of GMP Clearance Approvals

On 18 February 2021, Thai FDA announced that any GMP clearance approval letter which was approved before the date of …

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Malaysia MDA Issues Guidelines for Application for Medical Device Advertisement Approval – Requirements  

This guideline specifies the requirements for advertisement of medical devices that require approval and no approval required.  The following materials …

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Philippines FDA Starts Pilot Implementation of eServices Portal System for Drug Products 

The Philippines FDA, in its commitment to provide stakeholders with streamlined and improved government services, is developing the FDA eServices …

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Australia TGA Updates Comparable Devices in the Clinical Evidence Guidelines For Medical Devices

TGA has issued version 2.0 of Clinical evidence guidelines: Medical devices in March 2021 to update the section on Comparable …

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