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 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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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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Taiwan FDA to Start Pilot Testing of eCTD Submissions 

On 22nd March 2021, Taiwan FDA announced a plan on pilot testing of eCTD submission.   To ensure that 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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Vietnam MOH Implements Online System to Maintain Validity of Drug Licences

The Ministry of Health Vietnam has issued on 03 February 2021, Official letter No. 777/QLD-DK regarding implementation of online system …

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