MOHRSS will adjust catalogue of national basic medical insurance, employment injury insurance and maternity insurance

The Ministry of Human Resources and Social Security of the People’s Republic of China (MOHRSS) issued the Adjustment Plan for Drug Reimbursement List (Draft for Comment) (”Draft”) on 30 September 2016. According to the Draft, drugs of high clinical value, and drugs treating serious diseases, children, emergency situations, and occupational diseases are most likely to be added.

NHFPC propelling the three negotiated drugs to be reimbursed

The National Health and Family Planning Commission (“NHFPC”) issued the Opinion on Making Negotiated Drugs and New Rural Cooperative Medical Reimbursement Well Connected on 30 September 2016. The provincial HFPCs are required to add the negotiated drugs into the drug reimbursement lists of the New Rural Cooperative Medical and Basic Medical Insurance managed by local HFPCs, which will consider the local economic development, funding level, medical service, and disease spectrum.

The State Council seeks public comments on the Implementing Regulations of the Food Safety Law

The Implementing Regulations of the Food Safety Law (Draft for Comments) was issued on 19 October 2016 and is open for public comments until 19 November 2016. This Draft strengthens the administrative regime for special foods, i.e. healthcare foods, formula foods for special medical use, and infant formula foods. It also includes stricter requirements on labelling, instruction and advertisement; strengthening supervision and inspection of import food and implementing strictly legal liabilities for food manufacturers and traders.

The State Council issued the Outline of the Plan for Healthy China 2030

The State Council issued the Outline of the Plan for Healthy China 2030 (“Plan”) on 25 October 2016, which looks to build a healthy China by enhancing the innovation capability of patented drugs, new types of traditional Chinese medicines, new types of preparations, and advanced medical devices. The Plan encourages the launching of the generic drugs for the treatment of serious diseases and relevant patents that have been expired. It also encourages the development of biologics, new chemical drugs, and high performing medical devices.

CFDA establish Prior Approval for Medical Devices

CDFA published the Prior Review and Approval Procedure for Medical Devices (“Procedure”) on 25 October 2016, which will be implemented on 1 January 2017. This Procedure lists several circumstances under which medical devices can enjoy prior approval, includes devices which have brought clinical advantages in diagnosing and treating orphan diseases, cancer and paediatric diseases; devices diagnosing and treating elderly endemic diseases and common diseases that have no effective diagnosing and/or treatment method; and devices of national major science and technology projects or key research and development programs; and other reasonable circumstances.