China Lifesciences Monthly Update – January 2017

State Council published 13th Five-Year Plan for Healthcare Reform, 9 January

The State Council published the 13th Five-Year Plan for Healthcare Reform (“Plan”) on 9 January 2017. The Plan emphasises that a unified medical insurance system for urban and rural residents shall be established; reforms to the drug distribution system will be implemented, and the drug price formation regime will also be enhanced. The Plan also states that commercial bribery and other illegal and criminal acts will be cracked down on, and that private investment is encouraged within the healthcare services sector.

“Two Invoice System” to be Implemented, 9 January

The National Health and Family Planning Commission, the China Food and Drug Administration and six other authorities have jointly published the Implementing Opinions on Carrying out the “Two Invoice System” for Drug Procurement among Public Medical Institutions (“Opinion”). The Opinion defines the “two invoice System” to be where there is one invoice from the pharmaceutical manufacturer to the pharmaceutical distributor, and the other invoice from the pharmaceutical distributor to the medical institution. The system will be implemented gradually into public medical institutions in pilot districts, and encouraged in other districts. Full implementation of this system will likely be achieved in 2018.

CFDA seeks comments on the draft Good Clinical Practice, 1 December

The Good Clinical Practice (Revision Draft for Comment) (“Draft”) was published on 1 December 2016 and is open for public comments until 31 January 2017. The Draft is based on the international standard—ICH-E6 R2. The Draft stipulates stricter administration rules concerning the Institutional Review Board (IRB), investigators, sponsors, monitoring, the Contract Research Organisation (CRO), informed consent of the trial subject, trial protocol, investigator’s brochure and document management. Moreover, the requirements for risk management of computerised system and data administration are formulated in the Draft for the first time.

MOFCOM issued the Development Plan of Drug Distribution Industry, 29 December

The Ministry of Commerce (“MOFCOM”) published the Development Plan of Drug Distribution Industry (“Plan”) on 29 December. The Plan promotes the application of the internet and the Internet of Things (IOT) in the drug distribution sector. Foreign drug distributors are encouraged to expand their investment in China and participate in domestic M&A activities. The Plan also states that the relevant laws, regulations and policies will be refined gradually, especially the revision of the Drug Administration Law.

CFDA seek comments on Measures for the Inspection on Advertisements of Pharmaceutical Products, 14 December

CFDA published Measures for the Advertisements Inspection on Drugs, Medical Devices, Healthcare Food and Formula Foods For Special Medical Use (Draft for Comment) (”Draft”) on 14 December 2016 which is open for public comments until 13 January 2017. According to the Draft, advertisements for medical devices, healthcare foods and formula foods for special medical use will also subject to the drug administration regime. Internet advertisement shall be supervised according to the Draft. Administration on publishing drug advertisements in other places is released.