Under the Proposal for Institutional Reform in Shanghai, the responsibilities of registration, supervision, administration, and other related tasks concerning drugs, cosmetics, and medical apparatus and instruments previously handled by the Shanghai Municipal Food and Drug Supervision Administration have been consolidated. As a result, the Shanghai Municipal Drug Administration has been established as a departmental management agency operating under the Shanghai Municipal Administration for Market Regulation.

Main responsibilities are as follows:

1. Ensure the safety supervision of drugs (including traditional Chinese medicine and ethnic medicine), medical apparatus and instruments, and cosmetics. Implement relevant laws, regulations, rules, guidelines, and policies pertaining to the safety supervision of these products. Conduct studies and draft local rules, regulations, and policy plans, overseeing their implementation. Implement policies that encourage the development of new technologies and products in the fields of drugs, medical apparatus and instruments, and cosmetics, while providing excellent service.

2. Supervise the implementation of national standards for drugs, medical apparatus and instruments, and cosmetics. Develop, revise, and issue local drug quality standards. Participate in the formulation of the essential drug list for the Municipality, and collaborate with relevant departments to implement the national essential drug system.

3. Manage the registration process for drugs, medical apparatus and instruments, and cosmetics in accordance with the law. Implement a registration management system, rigorously examine and approve their market launch, enhance the examination and approval system, and service facilitation measures, ensuring their effective implementation.

4. Conduct administrative licensing and supervision for pharmaceutical manufacturing, manufacturing of medical apparatus and instruments, preparations by medical institutions, and production of cosmetics. Administer the necessary licensing and supervision for pharmaceutical trading enterprises within its scope of responsibility.

5. Organize and oversee the implementation of quality management standards for drugs, medical apparatus and instruments, and cosmetics. Ensure compliance with product quality management standards and provide supervision and guidance for the implementation of operation and use quality management standards in accordance with the law.

6. Manage the post-marketing risks associated with drugs, medical apparatus and instruments, and cosmetics. Develop and implement a selective quality inspection plan for these products. Organize and conduct monitoring, assessment, and handling of adverse reactions for drugs, adverse events for medical devices, and adverse reactions for cosmetics. Undertake safety emergency management for drugs, medical apparatus and instruments, and cosmetics in accordance with the law.

7. Enforce the licensed pharmacist qualification access system. Register licensed pharmacists and supervise the implementation of the licensed pharmacist qualification access system.

8. Organize and provide guidance for the supervision and inspection of drugs, medical apparatus and instruments, and cosmetics. Develop relevant inspection systems and organize investigations and penalties for illegal activities in the production stage in accordance with the law. Coordinate and guide investigations and penalties for illegal activities in the stages of operation and use.

9. Organize and conduct safety awareness campaigns, training programs, and educational initiatives related to drugs, medical apparatus and instruments, and cosmetics. Facilitate international exchange and cooperation in these areas.

10. Provide guidance to district-level market supervision and administration departments regarding the safety supervision and management of drugs, medical apparatus and instruments, and cosmetics.

11. Fulfill additional tasks assigned by the CPC Shanghai Municipal Committee and the Shanghai Municipal People’s Government.