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sFDA CHINA

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http://eng.sfda.gov.cn/WS03/CL0755/

The State Food and Drug Administration (SFDA) (Chinese: 国家食品药品监督管理局) is founded on the basis of the State Drug Administration. The State Food and Drug Administration is directly under the State Council of the People’s Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China.

On July 10, 2007, Zheng Xiaoyu, the former head of China’s State Food And Drug Administration, was executed for taking bribes from various firms in exchange for state licenses related to product safety.[1]

Main responsibilities

  1. To organize relevant authorities to draft laws and regulations on the safety management of food, health food and cosmetics; organize relevant authorities to formulate comprehensive supervision policy, work plan and supervise its implementation.
  2. To exercise comprehensive supervision on the safety management of food, health food and cosmetics in accordance with laws; organize and coordinate supervision work on the safety of food, health food and cosmetics carried out by relevant authorities.
  3. To organize and carry out investigation and impose punishment on serious safety accidents of food, health food and cosmetics; delegated by the State Council, organize, coordinate and conduct specific law-enforcement campaigns over safety of food, health food and cosmetics nationwide; organize, coordinate and collaborate with relevant authorities in carrying out emergency rescue work on serious safety accidents of food, health food and cosmetics.
  4. To draft law and regulations on administration of medical devices and supervise their enforcement; take charge of registration and regulation of medical devices; draft relevant national standards, draw up and revise professional standards of medical devices, manufacturing practice and supervise their implementation.
  5. To be in charge of drug registration, draw up, revise and promulgate national standard of drugs; draw up criteria for marketing authorization of health food; review and approve health food; set up classification system for prescription drugs and OTC drugs; establish and improve ADR monitoring system; be responsible for drug reevaluation, review drugs to be withdrawn and formulate a national essential medicines list.
  6. To draft and revise good practices for drug research, manufacturing, distribution and use, and supervise their implementation.
  7. To control the quality of drugs and medical devices in manufacturers, distributors and medical institutions; release national quality bulletin on drugs and medical devices on a regular basis; investigate and punish illegal activities of producing and selling counterfeit and inferior drugs and medical devices in accordance with law.
  8. To regulate radioactive pharmaceuticals, narcotics, toxics, psycho -tropics, and other controlled drugs and devices in accordance with law.
  9. To draw up and improve qualification system for licensed pharmacist, supervise and direct the registration of licensed pharmacist.
  10. To direct national drug regulation and comprehensive supervision on the safety management of food, health food and cosmetics.
  11. To carry out exchanges and cooperation in drug regulation, relevant safety management of food, health food and cosmetics with foreign governments and international organizations.
  12. To undertake other work assigned by the State Council.

The State Food and Drug Administration is not responsible for regulating pharmaceutical ingredients manufactured and exported by chemical companies. This regulatory hole, which has resulted in considerable international news coverage unfavorable to China, has been known for a decade, but failure of Chinese regulatory agencies to cooperate has prevented effective regulation.[2]

Commissioner

Commissioner: Mr. Li Yin

Deputy Commissioners: Mr. Zhen, Mr. Jiping Li & Mr. Zhenjia Bian

Contact

State Food and Drug Administration Address: 26 Xuanwumen Xidajie, Beijing, 100053, P.R. China Fax: 86-010-68310909

  1.  China food safety head executed
  2.  “Chinese Chemicals Flow Unchecked to World Drug Market” article reported by Walt Bogdanich, Jake Hooker and Andrew W. Lehren and written by Mr. Bogdanich in the New York Times October 31, 2007

  • Dali Yang, “Regulatory Learning and Its Discontents in China: Promise and Tragedy at the State Food and Drug Administration,” in John Gillespie and Randall Peerenboom, eds., Pushing Back Globalization, Routledge, 2009.

People’s Republic of China

  • 中华人民共和国
  • Zhōnghuá Rénmín Gònghéguó
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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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