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 …
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 …
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 …
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 …
Thailand Releases New Regulations and Guidelines on Report of Device Defects, Adverse Events Occurred to Consumers, and FSCA of Medical Devices
5 documents have been released by the Ministry of Public Health and Thai FDA regarding revised reporting of device defects, …