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國家食品藥品監督管理總局 CFDA China Food and Drug Administration  
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國家食品藥品監督管理局是國務院綜合監督食品、保健品、化妝品安全管理和主管藥品監管的直屬機構， 負責對藥品（包括中藥材、中藥飲片、中成藥、化學原料藥及其制劑、抗生素、生化藥品、生物制品、診斷藥品、放射性藥品、麻醉藥品、毒 性藥品、精神藥品、醫療器械、衛生材料、醫藥包裝材料等）的研究、生產、流通、使用進行行政監督和技術監督；負責食品、保健品、化妝 品安全管理的綜合監督、組織協調和依法組織開展對重大事故查處；負責保健品的審批。

其主要職責是：

　　（一）組織有關部門起草食品、保健品、化妝品安全管理方面的法律、行政法規；組織有關部門制定食品 、保健品、化妝品安全管理的綜合監督政策、工作規劃并監督實施。

　　（二）依法行使食品、保健品、化妝品安全管理的綜合監督職責，組織協調有關部門承擔的食品、保健品 、化妝品安全監督工作。

　　（三）依法組織開展對食品、保健品、化妝品重大安全事故的查處；根據國務院授權，組織協調開展全國 食品、保健品、化妝品安全的專項執法監督活動；組織協調和配合有關部門開展食品、保健品、化妝品安全重大事故應急救援工作。

　　（四）綜合協調食品、保健品、化妝品安全的檢測和評價工作；會同有關部門制定食品、保健品、化妝品 安全監管信息發布辦法并監督實施，綜合有關部門的食品、保健品、化妝品安全信息并定期向社會發布。

　　（五）起草藥品管理的法律、行政法規并監督實施；依法實施中藥品種保護制度和藥品行政保護制度。

　　（六）起草醫療器械管理的法律、行政法規并監督實施；負責醫療器械產品注冊和監督管理；起草有關國 家標準，擬訂和修訂醫療器械產品行業標準、生產質量管理規范并監督實施。

　　（七）注冊藥品，擬訂、修訂和頒布國家藥品標準；擬訂保健品市場準入標準，負責保健品的審批工作； 制定處方藥和非處方藥分類管理制度，建立和完善藥品不良反應監測制度，負責藥品再評價、淘汰藥品的審核和制定國家基本藥物目錄的工作 。

　　（八）擬訂和修訂藥品研究、生產、流通、使用方面的質量管理規范并監督實施。

　　（九）監督生產、經營企業和醫療機構的藥品、醫療器械質量，定期發布國家藥品、醫療器械質量公報； 依法查處制售假劣藥品、醫療器械等違法行為。

　　（十）依法監管放射性藥品、麻醉藥品、毒性藥品、精神藥品及特種藥械。

　　（十一）擬訂和完善執業藥師資格準入制度，監督和指導執業藥師注冊工作。

　　（十二）指導全國藥品監督管理和食品、保健品、化妝品安全管理的綜合監督工作。

　　（十三）開展藥品監督管理和食品、保健品、化妝品安全管理有關的政府間、國際組織間的交流與合作。

　　（十四）承辦國務院交辦的其他事項。

About SFDA
Main Responsibilities
1. To formulate policies and programs on the administration of drugs, medical devices, health food and cosmetics, as well as food safety at consumption stage (restaurant, cafeteria, etc.) and supervise their implementation; to bear a part in drafting relevant laws, regulations and normative documents;

2. To take charge of food hygiene licensing and food safety supervision at consumption stage;

3. To formulate good practice for food safety at consumption stage and supervise its implementation, carry out investigation and monitoring work of food safety at consumption stage, and release information related to supervision on food safety at consumption stage;

4. To take charge of health food, cosmetic hygiene licensing, hygiene supervision and relevant review and approval work;

5. To take charge of administrative and technical supervision of drugs and medical devices, take charge of formulating good practices for drugs, medical devices in aspects of research, production, distribution and use, and supervise their implementation;

6. To take charge of registration and supervision of drugs and medical devices; draw up relevant national standards of drugs and medical devices, and supervise their implementation; carry out the Adverse Drug Reaction (ADR) monitoring and adverse event monitoring of medical devices; be responsible for drug and medical device re-evaluation and elimination; bear a part in formulating national essential medicine list and adopting the national essential medicine system, and organize the implementation of classification system for prescription drugs and non-prescription drugs;

7. To take charge of formulating regulations of Traditional Chinese Medicines (TCMs) and ethno-medicines, and supervise their implementation, draw up quality standards of TCMs and ethno-medicines, formulating Good Agricultural Practices for Chinese crude drugs and Processing Standards for prepared slices of Chinese crude drugs and supervising their implementation, and carry out protection system for certain TCMs;

8. To supervise the quality and safety of drugs and medical devices, to regulate radioactive pharmaceuticals, narcotics, toxics and psychotropics, and release quality and safety information of drugs and medical devices;

9. To organize the investigation and punishment of illegal activities on food safety at consumption stage, and on research, production, distribution and use of drugs, medical devices, health food and cosmetics;

10. To direct relevant local work regarding food and drug administration, emergency response, inspection and informationalization;

11. To draw up and improve qualification system for licensed pharmacist, direct and supervise the registration of licensed pharmacist;

12. To carry out international exchanges and cooperation related to food and drug regulation;

13. To undertake other work assigned by the State Council and the Ministry of Health.