On 22 September 2020, Notification of the Thai Ministry of Public Health Re: Rules, Methods and Condition for Display of Labels and Package Inserts of Medical Devices B.E. 2563 [2020]
Regulatory News
China Revises the Provisions for Lot Release of Biological Products
Pursuant to the new Vaccine Administration Law and the revised Drug Administration Law, the Provisions for Lot Release of Biological Products was revised by the State Administration for Market Regulation,
Hong Kong Department of Health (DoH) to Enhance Regulatory Control of Skin Antiseptic Products
To safeguard public health in the safe and proper use of all skin antiseptic products containing substances other than chlorhexidine, the Department of Health of Hong Kong decided that under
China’s NMPA Signs MoU on Regulatory Cooperation with Italian Medicines Agency
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
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
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
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
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
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