China’s Healthcare Policy and Regulation Collection September 2018
12/28/2018
China releases plan to reduce sugar intake for oral health improvement
02/24/2019

China’s Healthcare Policy and Regulation Collection February 2019

1. Opinions on Accelerating the Popularity and Application of Electronic Health Card issued by National Health Commission

To gradually optimize the diagnosis and treatment service process, deepen the convenient information application to benefit people and lay solid foundation for the development of health informationzation and big data on health and medical treatment, in accordance with the sprit of the documents such as Opinions of General Office of the State Council on Promotion the Development of “Internet + Medical Health” (No. [2018] 26 of General Office of the State Council) and the Notice of National Health Commission and National Administration of Traditional Chinese Medicine on Deeply Carrying out “Internet + Medical Health” Convenient and Benefiting Campaign (No. [2018] 22 of National Health Commission) etc., it is to propose to speed up the construction of basic supporting environment for electronic health card for speeding up to accelerate the popularity and application of electronic health card, strengthen the management of uniform registration of health logo and accepting treatment with the true name; actively carry out the convenient and benefiting services with electronic health card; and proactively promote the application of health and finance integration and innovation services and take great efforts to improve the security construction and management of electronic health card application.

2. Notice on Printing the Specifications on Recording the Whole Process of Administrative Law Enforcement on Hygiene and Health issued by National Health Commission:

To further regulate the law enforcement on hygiene and health, in accordance with the requirements of the State Council on fully promoting the system on fully recording the whole process of law information, National Health Commission promulgated Specifications on Recording the Whole Process of Administrative Law Enforcement which shall be applicable to administrative permit, administrative fine, administrative arbitrariness and administrative supervision and examination etc. The other types of law enforcement shall be otherwise stipulated by the provincial health administrative department in accordance with the laws and regulations and relevant rules and normative documents of the National Health Commission and in combination with the local realities.

3. Decisions of State Administration for Market Regulations on Amending Three Regulations including Methods on Drug Advertisement Examination issued by State Administration for Market Regulations: 

On December 26, 2018, State Administration for Market Regulations issued Decisions of State Administration for Market Regulations on Amending Three Regulations including Methods on Drug Advertisement Examination and revised Methods on Drug Advertisement Examination and Methods on Medical Device Advertisement Examination. Among these, in Methods on Drug Advertisement Examination, the relevant provisions on application for drug advertisement approval number and filing application on placing the drug advertisements in the other places have been amended; whereas in Methods on Medical Device Advertisement Examination, the relevant provisions on application for medical device advertisement approval number and term of examining the medical device advertisement have been amended.

4. Notice of National Medical Products Administration on Strengthening Centralized Drug Purchase and Drug Regulation and Administration during Pilot Use issued by National Medical Products Administration: 

On December 27, 2018, National Medical Products Administration issued Notice of National Medical Products Administration on Strengthening Centralized Drug Purchase and Drug Regulation and Administration during Pilot Use with the main content as follows: deeply realize the key significance of pilot, strengthen the drug production regulation, enhance the drug distribution and use regulation, improve the drug random examination and adverse reaction monitoring, and further promote the consistency evaluation, carry out the strategy of innovation-driven development and drive the higher quality development and work requirement for the drugs. The work requirements include full implementation of territorial management accountability, fully strengthening the coordination among the departments and information communication and comprehensively imposing strict punishment on illegal acts on drugs.

5. Announcement on Relevant Matters Concerning Quality of Generic Drug and Consistency Evaluation on Curative Effect issued by National Medical Products Administration: 

On December 28, 2018, National Medical Products Administration issued Announcement on Relevant Matters concerning Quality of Generic Drug and Consistency Evaluation on Curative Effect, with the main content including: be strict in evaluation standard, strengthen regulation after launching to the market; quality takes precedence over time, and reasonably adjust the time limit and requirements on relevant work; improve the service guidance and fully promote the consistency evaluation; intensify the support of accompanying policies and mobilize the companies’ evaluation enthusiasm. As for the varieties that have passed the consistency evaluation, such varieties shall be preferentially included in National Essential Medicine List and those that have not passed the consistency evaluation shall be moved out of the List. The varieties that have been included in the National Essential Medicine List shall not be subject to the uniform time limit requirements on evaluation.

6. Center for Drug Evaluation issued Second Batch of Drug List with the Patent Expired, Terminated, Invalid and without Abbreviated New Drug Application

On December 24, 2018, Center for Drug Evaluation issued Second Batch of Drug List with the Patent Expired, Terminated, Invalid and without Abbreviated New Drug Application and the drugs included in the List are: as of October 2018, the drugs that have been launched abroad and have the express clinic value with the patent expired, terminated, invalid and without the abbreviated new drug application, 7 varieties in total. 

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