Health Care Legal Newsletter
New Laws and Regulations on Health Care Field
Guidelines for the Administration of Clinical Pathways for Medical Institutions Issued
1. Enacted details
1) Promulgated authority: The National Health and Family Planning Commission and the State Administration of Traditional Chinese Medicine
2) Promulgation date：Sept 13,2017
3) Effective date：Sept 13, 2017
2. Related content
On Sept 13,2017, the National Health and Family Planning Commission ("NHFPC") and the State Administration of Traditional Chinese Medicine ("SATCM") have jointly released the Guidelines for the Administration of Clinical Pathways for Medical Institutions (the "Guidelines"), with immediate effect from the issue date.The main content of The Guidelines are as follows:
The Guidelines state that the administration of clinical pathways should be advanced under certain principles that require the combination with the medical quality control and the performance assessment, adjustments to medical service charges, the reform in methods of payment, and the information construction of medical institutions. Medical institutions should subject certain diseases selected under three principles, such as "common and prevalent diseases", to the administration of clinical pathways.
The Guidelines expressly state that medical institutions should actively cooperate with the price administrations and the basic medical insurance administrations in effectively estimating and calculating relevant expenses according to clinical pathways and pushing ahead reform in methods of payment, such as the payment based on a single disease and the payment based on diagnosis related groups (DRGs).
The Announcement on Adjusting the Acceptance of Drug Registration Applications (Draft for Comment)
1． Enacted details
1) Promulgated authority：The China Food and Drug Administration
2) Promulgation date：Sept 13 ,2017
3) Expiration date：Oct 12, 2017
2． Related content
On Sept 13,2017, The China Food and Drug Administration ("CFDA") has recently drafted and issued the Announcement on Adjusting the Acceptance of Drug Registration Applications (Draft for Comment) (the "Draft for Comment") for public comments by October 12, 2017.The main content of The Draft for Comment are as follows:
The Draft for Comment expressly states that from December 1, 2017, a drug registration application that should be accepted by a provincial authority and then evaluated and approved by the CFDA according to the existing policy will be accepted and handled by the CFDA in a centralized manner thereafter.
According to the Draft for Comment, any drug registration application subject to the evaluation and approval of the CFDA, such as an application for applying a new drug to clinical tests, an application for generic drugs, a supplementary application to be approved by the CFDA, and an application for reporting the drug package materials or pharmaceutical excipients associated with an application for registering a domestic drug, will be accepted and handled by the CFDA. However, any drug registration application subject to approval of a provincial authority shall be still accepted and handled by such provincial authority as before.
The Circular on Regulating the Relevant Work Concerning the Classification of Medical Device Products
1． Enacted details
1) Promulgated authority: The General Office of the China Food and Drug Administration
2) Promulgation date：Sept 27,2017
3) Effective date：Aug 1,2018
2． Related content
On Sept 27,2017, the General Office of the China Food and Drug Administration ("CFDA") has distributed the Circular on Regulating the Relevant Work Concerning the Classification of Medical Device Products (the "Circular"), effective from August 1, 2018.The main content of The Circular are as follows:
The Circular regulates procedures to categorize and demarcate medical devices, some circumstances requiring the confirmation of relevant categories, adjustments to the category catalog, etc.
The Circular expressly states that where an applicant proposes, according to Article 16 of the Regulations on Supervision and Administration of Medical Devices, to apply for confirming the category of a medical device that is newly developed but has not been included into the Category Catalog for Medical Devices, or the classification or demarcation notice or other documents, it should file the application for classification or demarcation through the classification and demarcation information system of the Medical Device Standard Management Center ("Standard Management Center") under the CFDA.
the Circular states that the Standard Management Center will prepare and launch the public database for the category catalog in due course and maintain the database for the category catalog.
The Decision on Revising Some Rules and Regulations (Draft for Comment)
1． Enacted details
1) Promulgated authority：The China Food and Drug Administration
2) Promulgation date：Sept 29,2017
3) Expiration date: Oct 29, 2017
2． Related content
On the Sept 29,2017,The China Food and Drug Administration ("CFDA") has issued the Decision on Revising Some Rules and Regulations (Draft for Comment) (the "Draft for Comment") for public comments by October 29, 2017.The main content of The Draft for Comment are as follows:
According to the Draft for Comment, "photocopies of the enterprise's business license (a newly established enterprise shall provide the Pre-approval Notification of Enterprise Names issued by the administration for industry and commerce and relevant materials)", as specified in Article 13 Item 1 of the Administrative Measures for Drug Information Services on the Internet, are changed into the "photocopies of the enterprise's business license".
Additionally, the Draft for Comment decides that the first paragraph in Article 28 of the Measures of the Supervision and Administration of Pharmaceutical Manufacturing is revised to read as "the application for entrusting a party to manufacture drugs shall be accepted, examined and approved by both food and drug administrations of the provinces, autonomous regions or municipalities directly under the Central Government where the principal and the entrustee are located respectively".
Furthermore, the Draft for Comment proposes amendments to the Administrative Measures for Pharmaceutical Trading Licenses, the Measures for the Supervision and Administration of Medical Device Production, and the Measures on the Supervision and Administration of the Business Operations of Medical Devices.
The Standards for Censoring and Launching Advertisements of Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purposes (Draft for Comment)
1． Enacted details
1) Promulgated authority：The State Administration for Industry and Commerce
2) Promulgation date：Sept 29,2017
3) Expiration date: Oct 20, 2017
2． Related content
On Sept 29,2017,the State Administration for Industry and Commerce ("SAIC") has issued the Standards for Censoring and Launching Advertisements of Drugs, Medical Devices, Dietary Supplements and Foods for Special Medical Purposes (Draft for Comment) (the "Draft for Comment") for public comments by October 20, 2017.
The Draft for Comment stipulates that it is prohibited to release advertisements of four categories of drugs, medical devices, dietary supplements and foods for special medical purposes, including "narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive pharmaceuticals, pharmaceutical precursor chemicals, and drugs and medical devices used for drug rehabilitation".
In addition, advertisements of drugs, medical devices, dietary supplements and foods for special medical purposes shall be released and used appropriately under guidance, and shall not present certain content, such as the guarantee that refund will be given if products are found ineffective or that the products have been insured at insurance companies.
Moreover, the Draft for Comment clearly specifies that as to advertisements of drugs, medical devices, dietary supplements and foods for special medical purposes to be launched on the internet, applications must be filed according to these Standards for approval, and such advertisements shall not be released if not approved.
The Opinions on Deepening the Reform of Evaluation and Approval System to Inspiring Innovation of Drugs and Medical Devices
1． Enacted details
1) Promulgated authority：The General Office of the Communist Party of China Central Committee and the General Office of the State Council
2) Promulgation date：Oct 9,2017
3) Effective date: Oct 9, 2017
2． Related content
On Oct 9,2017,the General Office of the Communist Party of China Central Committee ("CPCCC") and the General Office of the State Council have issued the Opinions on Deepening the Reform of the Evaluation and Approval System and Inspiring Innovation of Drugs and Medical Devices (the "Opinions").The main content of The Opinions are as follows:
Propose 36 concrete measures in six aspects, including "reforming administration of clinical trials", "accelerating evaluation and approval processes before relevant products are launched on the market" and "promoting innovation of drugs and development of generic drugs".
Clearly specify that the qualification accreditation of a clinical trial agency shall be subject to record-filing administration. An agency that has met conditions for clinical trials should not carry out clinical trials as entrusted by an applicant for having its drugs or medical devices registered until it has filed a record on a website designated by the food and drug administration.
State that overseas enterprises and scientific research institutes are allowed to conduct synchronous clinical trials in China for new drugs according to the law; also, efforts will be made to set up a prioritized evaluation and approval regime based on the compulsory patent licensing; allowing medical device R&D institutions and scientific research personnel to apply for the license for launching medical devices on the market.
Pharmaceutical Industry Updates
Shanghai Health and Family Planning Commission：Issues Anti-Commercial Bribe Regulation for the Medical Industry
The Shanghai Regulation on Commercial Bribe in the Purchase and Sale of Medicines will take effect from September 15, 2017.
The regulation stipulates that staff at medical institutions would be dismissed for accepting commercial bribes worth RMB 5,000 or above, accepting commercial bribes for two times or more or asking for commercial bribes; corrupt doctors shall have their licenses revoked by health and family planning authorities. Those who accept bribes worth below RMB 5,000 shall also be subject to administrative punishments, such as revocation of qualification and suspension of practice.
Six ministries le by the Ministry of Civil Affairs, the National Development and Reform Commission and the Ministry of Science and Technology：Pilot-Run Innovation of Rehabilitation Assistive Device Industry
On Sept 20,2017,Six ministries by the Ministry of Civil Affairs, the National Development and Reform Commission and the Ministry of Science and Technology, issued a joint circular on running the pilot program of innovation in the rehabilitation assistive device industry.
According to the circular, 12 prefecture-level administrative regions will be included in the pilot program, which will promote industrial agglomeration, establish service networks, innovate the model of combining government, industry, academia, research and application, pursuit integrated development, enhance the connection of the industry with old care service, aid for people with disabilities, and medical and health industry, and broaden the application of rehabilitation assistive devices in these industries.
The pilot program will last for two years, starting from the day when the name list of pilot regions is revealed.
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Healthcare legal Newsletter Editor-in-chief：Richard Lee Stone Shen
Editorial board：（Ranked in no particular order）Jianfeng Wang Andy Wang Yong Deng Bailey Xu Daniel Wei Ken Dai Lu Wang George Zheng Mingzhen Zhu Kingston Wang Shane Luo Jiacai Tan Bruce Lee Lu Zhou Feng Sheng Chunfeng He David Chen Zhongcheng Ma Vic Li Lihua Tan Nancy Ji Tina Liu
Editors of this issue：Stone Shen