China’s NMPA signs MoU on regulatory cooperation of medicines, medical devices, cosmetics with Italian Ministry of Health, Italian Medicines Agency.
The closing ceremony of the 10th joint plenary session of the
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South Korea MFDS Launched Search Database for Herbal Medicine Related Information
The Ministry of Food and Drug Safety has launched a database of ‘National Herbal Medicine Information’ on 21 December 2020 so that information on herbal medicines can be searched by
read more...South Korea MFDS to Improve the Information Disclosure Process for Drug Approval Results
The Ministry of Food and Drug Safety announced on 21 December 2020 that it will improve the information disclosure process for drug approval and review results to expands disclosure of
read more...Australia’s Transition for Permitted Indications for Listed Medicines Ends 5 March 2021
On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under section 26A of the Therapeutic Goods Act 1989 (the Act). All new listed medicines included
read more...Australia TGA Designs a New Regulatory Framework for Personalized Medical Devices (Including 3D-Printed Devices)
Under the current medical devices, regulatory framework custom-made medical devices are exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG). Since the introduction of
read more...Australia TGA’s Staged Transition to eCTD-only for Prescription Medicines from 1 November 2020
This transition will see Australia adopt best practice standards that are currently applied across the world. Providing benefits for both sponsors and regulators, the use of eCTD will enhance lifecycle
read more...Singapore HSA Streamlines Stability Data Requirements for Therapeutic Product Registration
Singapore HSA has revised the Guidance on Therapeutic Product Registration in Singapore and Related Appendices. The changes will take effect for applications submitted from 31 Dec 2020.
Streamlined stability
read more...Malaysia NPRA Issues Directive on Registration and Enforcement of Cell and Gene Therapy Products(CGTPs) in Stages
On 14 Dec 2020, Malaysia NPRA issues Directive 19 of 2020 on Registration And Enforcement Of Cell And Gene Therapy Products(CGTPS In Stages And Additional List Of Products Outside The Scope
read more...Singapore HSA Singapore Launches New Digital Health Webpage
HSA launched this webpage in December 2020 as a one-stop portal to encourage innovation in the area of digital health by providing greater clarity on the regulatory controls and guidelines
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