In April 2021, Hong Kong Department of Health updated the GN-03, Guidance Notes for Adverse Event Reporting by Local Responsible Persons.
Under the MDACS, the Local Responsible Persons (LRPs) are required, among
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Australia TGA Publishes New Guidance on the Management of GMP Compliance Signals
The guidance dated version 1.0 May 2021, outlines the Good Manufacturing Practice (GMP) compliance requirements for manufacturing biologicals and medicines intended for supply in Australia and TGA’s framework for managing
read more...Australia TGA Updates Regulatory Position for Data Collection Components Used by Software As a Medical Device
Rapid innovation in technology has driven significant changes to software function and adoption, giving rise to a larger number of devices able to inform, drive or replace clinical decisions, or directly provide
read more...Australia TGA Issues 3 Guidances on Transitional Arrangements and Obligations on Reclassification of Medical Devices in April 2021
Reclassification of Active Medical Devices for Therapy with a Diagnostic Function. Version 1.0, April 2021: https://www.tga.gov.au/resource/reclassification-active-medical-devices-therapy-diagnostic-function
This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their
read more...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 regulate and guide the pharmacovigilance activities of drug marketing authorization
read more...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 of the patent information registration platform related to the early
read more...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.
Additional import and export controls under the Health Products (Therapeutic Products)
read more...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 approval from a reference agency for the regulatory filing to
read more...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 of e-labelling is to facilitate efficient and timely dissemination of
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