CDE of China Issues Guidelines for Drug Information Changes

The Center for Drug Evaluation (CDE) released the “Marketed Chemicals Pharmaceutical Changes Study Technical Guidelines (Trial)”, “Marketed Chemicals and Biological …

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Thailand’s New Notification Regarding Rules, Methods and Condition for Display of Labels and Package Inserts of Medical Devices 2020

On 22 September 2020, Notification of the Thai Ministry of Public Health Re: Rules, Methods and Condition for Display of …

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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 …

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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, …

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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. …

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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 …

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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 …

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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 …

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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 …

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