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)
Regulatory News
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
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 are controlled through self-regulation, and shall comply with the requirements of
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 Portal System – an online platform for FDA marketing authorization
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 devices including substantially equivalent devices.
The first step in the comparability
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, Adverse Events Occurred to Consumers, and FSCA of Medical Devices.
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 eCTD submission platform functions smoothly, Taiwan FDA will conduct pilot testing