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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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 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’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 …

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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 …

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Australia TGA to Allow Registration of Over-The-Counter Low Dose Cannabidiol

Australia Therapeutic Goods Administration (TGA) announced on 15 December 2020 a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from …

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