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
Regulatory News
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
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
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
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
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)
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
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
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 this announcement will have their validity extended to April 2022