Brief Introduction to China FDA 2014

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"Brief Introduction of China Food & Drug Administration" by Chang Yongheng, China Centre for Food and Drug International Exchange, China Food & Drug Administration

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Brief Introduction to China FDA 2014

  1. 1. CFDA CCFDIE 1 Brief Introduction of China Food and Drug Administration Chang Yongheng China Center for Food and Drug International Exchange China Food and Drug Administration April 9, 2014
  2. 2. CFDA CCFDIE April 9, 2014 2 Content  Background  Focus of Reform  CFDA Internal Offices and Main Responsibilities  Division of Regulatory Authority among Ministries  Division of Regulatory Authority between CFDA and local FDA
  3. 3. CFDA CCFDIE 3 Background Regulatory Model before Reform  Production Quality Inspection agency  Distribution Industry &Commerce agency  Catering Food and Drug agency …… April 9, 2014
  4. 4. CFDA CCFDIE 4 Focus of Reform 1. Integrate and centralize food safety regulatory authority. April 9, 2014
  5. 5. CFDA CCFDIE 5 Focus of Reform 2. Streamline and strengthen responsibility of different Ministries, co-operation to ensure food safety. 3. Establish and improve grass-roots food and drug management system. April 9, 2014
  6. 6. CFDA CCFDIE 6 Focus of Reform 4. Consolidate food and drug regulatory authority. April 9, 2014
  7. 7. CFDA CCFDIE 7 Focus of Reform 5. Strengthen and elevate food and drug regulatory capacity. 6. Transform and optimize government functions. CFDA cancels 4 administrative licensing items, delegate 5 items and integrate 5 items. April 9, 2014
  8. 8. CFDA CCFDIE State Council 8 CFDA Internal Offices and Main Responsibilities CFDA has administrative staffing of 345 17 Internal Offices Ministerial-level Agency … … SAWS SAIC AQSIQ CFDA April 9, 2014
  9. 9. CFDA CCFDIE 9 CFDA Internal Offices and Main Responsibilities  CFDA Main Responsibilities  1. Draft and formulate laws, regulations and normative documents;  2. Formulate the regulations on food administrative licensing and supervise its implementation;  3. Organize the formulation and publication of drug and medical device standards and classification system, and supervise their implementation;  4. Formulate the investigation and enforcement system and organize its implementation;  5. Establish food and drug emergency response system;  6. Formulate science and technology development plans for food and drug safety, and organize its implementation. April 9, 2014
  10. 10. CFDA CCFDIE 10 CFDA Internal Offices and Main Responsibilities 7 Departments of Administration General Office Comprehensive Department Department of Media and Publicity Department of Legal Affairs Department of Human Resources Department of International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs) Department of Planning & Finance April 9, 2014
  11. 11. CFDA CCFDIE 11 CFDA Internal Offices and Main Responsibilities 10 Departments of Operation 3 departments of food 2 departments of drug &cosmetics 2 departments of medical device 3 other departments April 9, 2014
  12. 12. CFDA CCFDIE 12 CFDA Internal Offices and Main Responsibilities 3 Departments of Food Department of Food Safety Supervision I Department of Food Safety Supervision II Department of Food Safety Supervision III April 9, 2014
  13. 13. CFDA CCFDIE 13 CFDA Internal Offices and Main Responsibilities 2 Departments of Drug & Cosmetics Dept. of Drug and Cosmetics Registration Dept. of Drug and Cosmetics Supervision April 9, 2014
  14. 14. CFDA CCFDIE 14 CFDA Internal Offices and Main Responsibilities 2 Departments of Medical Device Dept. of Medical Device Registration Dept. of Medical Device Supervision April 9, 2014
  15. 15. CFDA CCFDIE 15 CFDA Internal Offices and Main Responsibilities 3 Other Departments Dept. of Science and Technology Bureau of Investigation and Enforcement Dept. of Emergency Management April 9, 2014
  16. 16. CFDA CCFDIE 16 Main Affiliated Institutions and Responsibilities National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products (Center for Health Food Evaluation)) Center for Medical Device Evaluation Center for Complaints and Report National Institutes for Food and Drug Control (Center for Medical Device Standardization Administration) Chinese Pharmacopoeia Commission Center for Drug Evaluation 投诉举报中心 National statutory Institutions and the highest technical arbitration body for drugs and biological products Organize Chinese Pharmacopoei compilation, formulate and revise national Pharmaceutical standards as statutory national drug standard management agency Undertake national TCM protection and technical review of health food, cosmetics approval Responsible for technical review of drug registration appli- cations as CFDA Drug Registration technical review Agency Responsible for technical review of import medical devices and domestic Class Ⅲ medical Devices Accept complaints for illegal activities in medicines, medical devices, health food and cosmetics in development,production, distribution, use and catering food service Responsible for conducting pharmaceutical / medical device Adverse Reactions / events monitoring at home and abroad Center for Drug Reevaluation (National Center for ADR Monitoring) April 9, 2014 China Center for Food and Drug International Exchange (CCFDIE) Responsible for international exchange and cooperation activities with international organizations or the industry
  17. 17. CFDA CCFDIE 17 Division of Regulatory Authority among Ministries I. Food safety regulatory authority are converging. Main Regulatory Agency:5 2
  18. 18. CFDA CCFDIE 18 Division of Regulatory Authority among Ministries  II. Administrative convergence mechanism gradually established.  Food safety track system  CFDA Ministry of Agriculture  Import and export food safety information rapid notification system  CFDA AQSIQ  Food safety risk assessment and standard coordination system  CFDA NHFPC April 9, 2014
  19. 19. CFDA CCFDIE Division of Regulatory Authority among Ministries III. Judicial linkage mechanism gradually improved.  CFDA Ministry of Public Security April 9, 2014
  20. 20. CFDA CCFDIE 20 Division of Regulatory Authority between CFDA and local FDA Goal upper and lower linkage joint push pull smooth operation overall improvement April 9, 2014
  21. 21. CFDA CCFDIE 21 Division of Regulatory Authority between CFDA and local FDA  Drug regulation  CFDA is responsible for review and approval of new drugs and generic drug registration.  Local FDA is responsible for daily supervision and inspection of listed companies within areas under its jurisdiction. April 9, 2014
  22. 22. CFDA CCFDIE 22 Division of Regulatory Authority between CFDA and local FDA  Medical Device Regulation  CFDA is responsible for review and approval of Class Ⅲ and import medical device registration.  Local FDA is responsible for ClassⅠand Ⅱmedical device registration, as well as daily supervision and inspection of listed companies within areas under its jurisdiction. April 9, 2014
  23. 23. CFDA CCFDIE 23 Division of Regulatory Authority between CFDA and local FDA  Food safety supervision  CFDA is responsible for formulating policies, annual plans and unified information publication system.  Local FDA is responsible for administrative licensings , daily supervision and inspection of listed companies within areas under its jurisdiction. April 9, 2014
  24. 24. CFDA CCFDIE 24 Thanks for your Attention! April 9, 2014

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