DRUGS

China Exempts Anti-HIV Drugs from Import Duties

23 April 2021

On 29 March, the Ministry of Finance, the General Administration of Customs and the State Taxation Administration jointly issued a circular detailing the preferential tax treatment for importing anti-HIV/AIDS drugs. More

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China Unveils Technical Research Guidelines for TCM Compound

25 January 2021

On 26 November, the National Medical Products Administration issued a set of technical guidelines, for research studies on the production of traditional Chinese medicine (TCM) compounds that use herbal decoction methods. More

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China Implements Traceability System for Major Drugs

06 November 2020

China’s National Medical Products Administration (NMPA) announced on 10 October that it will act to develop a system for tracing information about major drugs, in compliance with the Drug Administration Law and requirements set out by the State Council. More

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Revised Clinical Trials Rules for Drugs to Take Effect in July 2020

27 May 2020

In order to deepen the reform of the system of evaluation, review and approval of drugs, promote studies on good clinical practice (GCP) on drugs and improve the quality of drugs, the National Medical Products Administration joined hands with the National Health Commission in revising the Good Clinical Practice on Drugs, which will take effect on 1 July 2020 to regulate the clinical trials of drugs for registration purposes. More

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China Launches Drug Marketing Authorisation Holder System

24 April 2020

Revised provisions for drug registration and the supervision of drug production recently announced by the State Administration for Market Regulation will take effect on 1 July 2020. More

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NMPA Clarifies Administration of Drugs

23 April 2020

The National Medical Products Administration (NMPA) recently issued a circular on matters concerning the supervision and administration of drugs (Circular No. 23 [2020]) in order to satisfy the requirements laid out in the revised Drug Administration Law of the People’s Republic of China, which took effect on 1 December 2019. More

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Guangdong Simplifies Record-Filing of Drug Package Inserts and Labels

14 April 2020

On 13 March, the General Office of the Guangdong Provincial Medical Products Administration issued a notice relating to record-filing of drug package inserts and labels (Yue Yao Jian Ban Xu No. 95 [2020]). It states that, in accordance with Announcement No. 103 [2019] of the National Medical Products Administration, all enterprises or drug development institutions holding a drug registration certificate will become drug marketing licence holders, with effect from 1 December 2019. More

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Online Pharmaceutical and Medical Device Sales Brought in Line with Offline Regulatory Regime

05 December 2017

In line with the principle that online and offline transactions should be subject to identical regulatory regimes, the online trade in pharmaceuticals and medical devices is to face the same level of scrutiny as sales made via more conventional channels. More

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Innovation Prioritised in Overhaul of Drugs and Medical Device Sectors

03 November 2017

Moves have been announced to restructure China’s pharmaceuticals and medical device sectors as a means of promoting greater innovation. More

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CFDA Employees Face Prosecution for Breaching Confidentiality on Drug and Medical Device Testing

29 June 2017

Any employees of the China Food and Drug Administration (CFDA) who breach confidentiality with regard to any information they have become privy to during the course of conducting their duties will now be liable to prosecution. More

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