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國家食品藥品監(jiān)督管理總局 CFDA China Food and Drug Administration  
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國家食品藥品監(jiān)督管理局是國務(wù)院綜合監(jiān)督食品、保健品、化妝品安全管理和主管藥品監(jiān)管的直屬機(jī)構(gòu)， 負(fù)責(zé)對(duì)藥品（包括中藥材、中藥飲片、中成藥、化學(xué)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(yī)療器械、衛(wèi)生材料、醫(yī)藥包裝材料等）的研究、生產(chǎn)、流通、使用進(jìn)行行政監(jiān)督和技術(shù)監(jiān)督；負(fù)責(zé)食品、保健品、化妝 品安全管理的綜合監(jiān)督、組織協(xié)調(diào)和依法組織開展對(duì)重大事故查處；負(fù)責(zé)保健品的審批。

其主要職責(zé)是：

　　（一）組織有關(guān)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(guī)；組織有關(guān)部門制定食品 、保健品、化妝品安全管理的綜合監(jiān)督政策、工作規(guī)劃并監(jiān)督實(shí)施。

　　（二）依法行使食品、保健品、化妝品安全管理的綜合監(jiān)督職責(zé)，組織協(xié)調(diào)有關(guān)部門承擔(dān)的食品、保健品 、化妝品安全監(jiān)督工作。

　　（三）依法組織開展對(duì)食品、保健品、化妝品重大安全事故的查處；根據(jù)國務(wù)院授權(quán)，組織協(xié)調(diào)開展全國 食品、保健品、化妝品安全的專項(xiàng)執(zhí)法監(jiān)督活動(dòng)；組織協(xié)調(diào)和配合有關(guān)部門開展食品、保健品、化妝品安全重大事故應(yīng)急救援工作。

　　（四）綜合協(xié)調(diào)食品、保健品、化妝品安全的檢測(cè)和評(píng)價(jià)工作；會(huì)同有關(guān)部門制定食品、保健品、化妝品 安全監(jiān)管信息發(fā)布辦法并監(jiān)督實(shí)施，綜合有關(guān)部門的食品、保健品、化妝品安全信息并定期向社會(huì)發(fā)布。

　　（五）起草藥品管理的法律、行政法規(guī)并監(jiān)督實(shí)施；依法實(shí)施中藥品種保護(hù)制度和藥品行政保護(hù)制度。

　　（六）起草醫(yī)療器械管理的法律、行政法規(guī)并監(jiān)督實(shí)施；負(fù)責(zé)醫(yī)療器械產(chǎn)品注冊(cè)和監(jiān)督管理；起草有關(guān)國 家標(biāo)準(zhǔn)，擬訂和修訂醫(yī)療器械產(chǎn)品行業(yè)標(biāo)準(zhǔn)、生產(chǎn)質(zhì)量管理規(guī)范并監(jiān)督實(shí)施。

　　（七）注冊(cè)藥品，擬訂、修訂和頒布國家藥品標(biāo)準(zhǔn)；擬訂保健品市場(chǎng)準(zhǔn)入標(biāo)準(zhǔn)，負(fù)責(zé)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(yīng)監(jiān)測(cè)制度，負(fù)責(zé)藥品再評(píng)價(jià)、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(chǎn)、流通、使用方面的質(zhì)量管理規(guī)范并監(jiān)督實(shí)施。

　　（九）監(jiān)督生產(chǎn)、經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)的藥品、醫(yī)療器械質(zhì)量，定期發(fā)布國家藥品、醫(yī)療器械質(zhì)量公報(bào)； 依法查處制售假劣藥品、醫(yī)療器械等違法行為。

　　（十）依法監(jiān)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(zhí)業(yè)藥師資格準(zhǔn)入制度，監(jiān)督和指導(dǎo)執(zhí)業(yè)藥師注冊(cè)工作。

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

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

　　（十四）承辦國務(wù)院交辦的其他事項(xiàng)。

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.