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 …
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 …
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 …
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 …
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 …
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. …
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 …
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 …
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 …