Beijing Municipal Medical Products Administration

I. Beijing Municipal Medical Products Administration (BMPA) is a sectoral management authority of subordinate bureau level, which is affiliated to Beijing Municipal Administration for Market Regulation.

II. BMPA implements the guidelines, policies, decisions and arrangements of the CPC Central Committee on market regulation for medical products and relevant work requirements proposed by the municipal Party committee, and adheres and strengthens the unified leadership of the Party on market regulation in the course of performing duties, which mainly include the followings:

1. To supervise and control the safety of drugs (including traditional Chinese medicine and ethnomedicine, the same below), medical devices and cosmetics in Beijing; to implement state laws, regulations and policies on the supervision and administration of drugs, medical devices and cosmetics, and draft and implement relevant local regulations and government regulations; and to formulate management and service policies to encourage the development of new technologies and products of drugs, medical devices and cosmetics.

2. To supervise the implementation of relevant standards and classified management system for drugs, medical devices and cosmetics; and to cooperate in the implementation of the national essential drug system.

3. To manage the registration of drugs, medical devices and cosmetics in Beijing; and to develop the registration management system, strictly review and approve product launch, and improve and implement the facilitation measures for review and approval services.

4. To be responsible for production licensing and quality management of drugs, medical devices and cosmetics, licensing of drug wholesale, licensing of retail chain headquarters, and record-keeping, supervision and management of third-party platforms for Internet sales; to supervise the implementation of production, operation and use quality management standards as per responsibilities; and to approve, supervise and manage drugs and medical devices advertisements.

5. To manage the risks after the launching of drugs, medical devices and cosmetics in Beijing; to monitor, evaluate and handle adverse reactions concerning drugs and cosmetics as well as adverse events concerning medical devices; and to carry out emergency management work associated with the safety of drugs, medical devices and cosmetics in accordance with laws.

6. To implement the qualification system for licensed pharmacists and the registration of licensed pharmacist in Beijing. 

7. To implement the supervision and inspection system for drugs, medical devices and cosmetics; to investigate and deal with the illegal acts in the process of drugs, medical devices and cosmetics production as well as the illegal acts of drug wholesale enterprises, retail chain headquarters and the third-party platforms for Internet sales in accordance with laws; to conduct and guide the investigation and punishment of illegal acts in drug retail, medical device and cosmetics business, as well as in drug and medical device use based on its responsibilities.

8. To promote policies and regulations, information release, foreign exchange and cooperation in the supervision and administration of drugs, medical devices and cosmetics in Beijing; and to promote the development of a credibility system.

9. To perform other tasks assigned by the municipal Party committee and the municipal government.

10. Transformation of functions.

A. To advance streamlining of administration and delegation of power. In particular, it is responsible for reducing specific administrative examination and approval items, and phasing out examination and approval system for advertisements of drugs and medical devices, drug clinical trial institutions, imported cosmetics for nonspecial purposes and other items, or implementing a recording system instead. 

B. To strengthen interim and ex-post regulation. Particularly, it is responsible for improving the management system for the whole life cycle of drugs and medical devices, strengthening management of quality and safety risks in the whole process, developing new regulatory approaches, enhancing credit supervision, fully implementing the policies to "select subjects and inspectors randomly and disclose the information publicly" and the model of "Internet + supervision", and improving the supervision efficiency to meet public demand for medical devices in the new era.

C. To effectively improve service level. Particularly, it is responsible for speeding up review and approval of innovative drugs and medical devices, improving the marketing license holder system and electronic review and approval procedures, optimizing the process and improving the efficiency, and creating an environment in which innovation is encouraged and legitimate rights and interests are protected; and for releasing timely the application information of drug registration and guiding applicants to conduct R&D and apply in an orderly manner.

D. To fully implement regulatory responsibilities. Particularly, it is responsible for following the requirements of "the strictest standard, the most stringent supervision, the harshest punishment and the most serious accountability", improving the evaluation, inspection, testing and monitoring systems of drugs, medical devices and cosmetics, and making the supervision team more professional; and for promoting the construction of consistency evaluation and traceability system for quality and efficacy of generic drugs, driving the main responsibilities of enterprises implemented, preventing systemic and regional risks, and ensuring the safety and effectiveness of drugs and medical devices.

11. Assignment of relevant responsibilities.

A. Assignment of responsibilities with the Beijing Municipal Administration for Market Regulation. The Beijing Municipal Medical Products Administration shall be responsible for licensing, inspection and punishment at the production stage of drugs, medical devices and cosmetics as well as licensing of drug wholesale, licensing of retail chain headquarters, and record-keeping, inspection and punishment of third-party platforms for Internet sales. The market regulatory authorities of all districts shall be responsible for the licensing, inspection and punishment for drug retail and medical device business, as well as the quality inspection and punishment for cosmetics business and the use of drugs and medical devices.

B. Assignment of responsibilities with the Beijing Municipal Health Commission. Beijing Municipal Medical Products Administration shall, in conjunction with Beijing Municipal Health Commission, establish the mutual notification and joint disposal mechanisms for major adverse reactions of drugs and adverse events of medical devices.

C. Assignment of responsibilities with Beijing Municipal Commerce Bureau. Beijing Municipal Commerce Bureau shall be responsible for formulating the development plans and policies for drug circulation in Beijing, while Beijing Municipal Medical Products Administration shall be responsible for collaborating to implement such plans and policies in drug supervision and administration. 

D. Assignment of responsibilities with Beijing Municipal Public Security Bureau. Beijing Municipal Public Security Bureau shall be responsible for organizing and guiding the investigation of criminal cases involving drugs, medical devices and cosmetics in Beijing. Beijing Municipal Medical Products Administration and Beijing Municipal Public Security Bureau shall establish a mechanism for linking administrative law enforcement and criminal justice. If Beijing Municipal Medical Products Administration discovers any illegal act that constitutes a crime, it shall promptly transfer the case to the public security authority as per relevant provisions, and the public security authority shall quickly conduct an examination and decide in favor of or against filing the case in accordance with the law. If the public security authority legally requests the medical products administration to provide assistance in the operations such as inspection, appraisal and accreditation, Beijing Municipal Medical Products Administration shall do so according to the law. If the public security authority finds a suspected case in violation of administrative laws and transfers it to the Medical Products Administration for investigation, Beijing Municipal Medical Products Administration shall accept and register it, and return the administrative handling result in a timely manner when the decision is made.

 E. In assignment of responsibilities with other departments, it shall take its share of responsibilities for drug supervision and administration as assigned.