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中国 . CFDA
国家食品药品监督管理总局
 
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国家食品药品监督管理局是国务院综合监督食品、保健品、化妆品安全管理和主管药品监管的直属机构, 负责对药品(包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、生物制品、诊断药品、放射性药品、麻醉药品、毒 性药品、精神药品、医疗器械、卫生材料、医药包装材料等)的研究、生产、流通、使用进行行政监督和技术监督;负责食品、保健品、化妆 品安全管理的综合监督、组织协调和依法组织开展对重大事故查处;负责保健品的审批。

 


 

 

国家食品药品监督管理局 SFDA  



其主要职责是:

 

  (一)组织有关部门起草食品、保健品、化妆品安全管理方面的法律、行政法规;组织有关部门制定食品 、保健品、化妆品安全管理的综合监督政策、工作规划并监督实施。

 

  (二)依法行使食品、保健品、化妆品安全管理的综合监督职责,组织协调有关部门承担的食品、保健品 、化妆品安全监督工作。

 

分分时时彩  (三)依法组织开展对食品、保健品、化妆品重大安全事故的查处;根据国务院授权,组织协调开展全国 食品、保健品、化妆品安全的专项执法监督活动;组织协调和配合有关部门开展食品、保健品、化妆品安全重大事故应急救援工作。

 

  (四)综合协调食品、保健品、化妆品安全的检测和评价工作;会同有关部门制定食品、保健品、化妆品 安全监管信息发布办法并监督实施,综合有关部门的食品、保健品、化妆品安全信息并定期向社会发布。

 

  (五)起草药品管理的法律、行政法规并监督实施;依法实施中药品种保护制度和药品行政保护制度。

 

  (六)起草医疗器械管理的法律、行政法规并监督实施;负责医疗器械产品注册和监督管理;起草有关国 家标准,拟订和修订医疗器械产品行业标准、生产质量管理规范并监督实施。

 

  (七)注册药品,拟订、修订和颁布国家药品标准;拟订保健品市场准入标准,负责保健品的审批工作; 制定处方药和非处方药分类管理制度,建立和完善药品不良反应监测制度,负责药品再评价、淘汰药品的审核和制定国家基本药物目录的工作 。

 

  (八)拟订和修订药品研究、生产、流通、使用方面的质量管理规范并监督实施。

 

  (九)监督生产、经营企业和医疗机构的药品、医疗器械质量,定期发布国家药品、医疗器械质量公报; 依法查处制售假劣药品、医疗器械等违法行为。

 

  (十)依法监管放射性药品、麻醉药品、毒性药品、精神药品及特种药械。

 

  (十一)拟订和完善执业药师资格准入制度,监督和指导执业药师注册工作。

 

  (十二)指导全国药品监督管理和食品、保健品、化妆品安全管理的综合监督工作。

 

  (十三)开展药品监督管理和食品、保健品、化妆品安全管理有关的政府间、国际组织间的交流与合作。

 

  (十四)承办国务院交办的其他事项。

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.


 

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