CFDA seeks public comments on the Adverse Events Monitoring and Re-evaluation of Medical Devices, 31 October 2016
The Administrative Measures for the Adverse Events Monitoring and Re-evaluation of Medical Devices (Draft for Comment) (“Draft”) was published on 31 October 2016 and is open for public comments until 30 November 2016. According to the Draft, any serious adverse effects of medical devices shall be reported immediately to a system called ‘National Monitoring Information Network for Adverse Events of Medical Devices’. For imported products and domestic products that are sold overseas, the manufacturers shall collect any serious adverse effects that occur overseas and report such events within 20 days.
Authorities issued the Planning Guidance of Pharmaceutical Industry Development, 9 November 2016
The CFDA and five other departments jointly published the Planning Guidance of Pharmaceutical Industry Development (“Guidance”) on 9 November, which aims to improve the enforcement of anti-monopoly and anti-unfair competition laws, reinforce the IP protection regime, and enhance the supervision of counterfeit and false advertising. The Guidance mentions a market driven drug price formation mechanism and deeper reform to the review and approval system for drugs and medical devices.
Deepen the Reform on Medical and Health System, 8 November 2016
The Opinions on Further Promoting the Experience in Deepening the Medical and Health System Reform ("Opinions") were issued on 8 November 2016. The Opinions state that the drug price mark-ups shall be cancelled in all public hospitals, and drug price negotiation regime will be applied to patented and exclusively manufactured drugs. A unified medical insurance system for urban and rural residents shall be established. Furthermore, non-public and public medical institutions will be treated equally in respect of market access, designated agencies for social insurance, technical access, etc.
Compilation Plan of Chinese Pharmacopoeia 2020 open for public comment, 4 November 2016
The Pharmacopoeia Commission of CFDA recently published the Compilation Plan of Chinese Pharmacopoeia 2020 (Draft for Comment) (“Draft”) to seek public comments until 1 December 2016. The Draft offers guidance for the compilation work of the 2020 edition of Chinese Pharmacopoeia. It aims to increase the types of drugs covered by the Chinese Pharmacopoeia and remove drugs that do not meet current standards. A Drug’s common clinical application, proven efficacy, safe usage, mature manufacturing process and controllable quality will be key considerations for inclusion on or removal from the list.
CFDA seek public comments on Administrative Measures for Drug Standards, 22 November 2016
The Administrative Measures for Drug Standards (Draft for Comment) (“Draft”) was published on 22 November 2016 and is open for public comments until 20 January 2017. According to the Draft, the Drug Standards include National Drug Standards, Drug Registration Standards, Provincial Local Standards, Standard for Chinese Traditional Drug and Standard for Medical Institutions’ Pharmaceutical Preparations. Technical requirements defined in the National Drug Standards would apply to all researchers, manufactures, operators, users and supervisors. Drugs which fail to satisfy the National Standards are prohibited from being manufacturing, distributing or being using. A six months’ transitional period will apply after the National Standards issued.