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 …
Singapore HSA Launches Innovation Office to Support Product Development
As part of the aim to facilitate the efficient development and timely registration of beneficial innovative therapeutic products (chemical and …
Singapore HSA Introduced New Self-Help Tool for Grouping of Medical Devices
On 25th February 2021, the Medical Devices Branch (MDB) has introduced a new self-help tool to guide in grouping of medical devices for …
Thailand Releases New Regulations on Medical Devices
New regulations came into effect on 15 February 2021 to harmonise Thailand’s Medical Device Act with the ASEAN Medical Device Directive. …
Vietnam MOH Implements Online System to Maintain Validity of Drug Licences
The Ministry of Health Vietnam has issued on 03 February 2021, Official letter No. 777/QLD-DK regarding implementation of online system …
Malaysia NPRA Strengthens Regulatory Control of Medicinal Gases Classified as Drugs
Malaysia NPRA issues Directive 8 of 2021 on Strengthening of the Implementation of Products Regulatory Control – Medical Gas Products …
Australia TGA Releases New Standard for Medicines with Data Matrix Codes or Serialisation
A new standard clarifying requirements for serialisation and data matrix codes on medicines supplied in Australia commences on 1 January …
Australia TGA Changes ARTG Inclusion Process for Class 1 IVD Medical Devices
On 4 December 2020, the TGA inclusion process for Class 1 in vitro diagnostic (IVD) medical devices in the Australian …
Singapore Health Sciences Authority Updates the Guidance for Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products
Singapore Health Sciences Authority has updated the Guidance for Industry: Product Defect Reporting and Recall Procedures for Therapeutic Products and …