An Overview of SFDA and Current Drug Administration in China

1. An Overview of SFDA and Current Drug Administration in China Chen Xingyu State Food and Drug Administration, September 6, 2005

2. Introduction – the SFDA • Founded on the basis of the State Drug Administration (SDA) in 2003 • Directly under the State Council • In charge of comprehensive supervision on the food safety management • The national regulatory authority ofdrug and medical device

3. Drug Administration System in China State Council SFDA Drug Administration at provincial level Affiliated Technical Institutions Drug Administration at city level Drug Administration at county level

4. Affiliated Technical Institutions • National Institute for the Control of Pharmaceuticals and Biological Products • State Pharmacopoeia Commission • Drug Evaluation Center • Drug Reevaluation Center • Drug Certification Center • National Committee on the Assessment of Protected TCM Products

5. Revised and approved at 20th Session of the Standing Committee of the 9th National People’s Congress and has come into effect since Dec. 1 , 2001

6. General Provisions Control over Drug Manufacturers Control over Drug Distributors Control over Pharmaceuticals in Medical Institutions Control over Drugs Control over Drug Packaging Control over Drug Pricing and Advertising Inspection of Drugs Legal Liabilities Supplementary Provisions

7. 《Regulation for Implementation of the Drug Administration Law of P.R. China》 Approved by State Council, and came into force from Sep. 15, 2002

8. Strict system of drug registration and approval • GMP certification is mandatory for drug manufacturers • Newly promulgated regulations

9. Drug Registration Legislation 1. Drug Administration Lawof P.R. China (Amended, 2001.12.01) 2. Regulations for Implementation of theDrug Administration Lawof P.R. China (Amended, 2002.09.15) 3. Provisions for Drug Registration (Amended, 2005.2.28)

10. Requirements for Drug Registration The manufacturing of new drug or generics must be approved by SFDA, and a drug approval number shall be issued (all drugs have to be approved) 2. Drug importation must be approved by SFDA, while its quality, safety, and efficacy having been confirmed, and the Import Drug License shall be issued. The import drug shall be approved by the manufacturing country originally. 3. SFDA shall evaluate new drug application by organizing experts in the field, such as pharmaceutical, medical.

11. Classification of Drug Application • New drug: any drug not marketed in China previously, Marketed drugs which are applied for change of dosage form, route of administration or adding new indication • Generics: drugs with official standards issued by SFDA (already marketed in China). • Import drugs: Manufactured abroad, to be marketed in China. • Supplementary application: for variations of already approved drugs.

12. Pre-conditions as Import Drug • All manufacturing process done overseas • Already Approved by the authority of origin for marketing • Manufacturing Compliance with GMP • For the purpose of marketing in China

13. Import Drug Applicant • Applicant is the License Holder in the country of origin • Applicant can not apply directly to SFDA, but through its representative office in China or a Chinese agent • The Representative office or Chinese agent shall bear the responsibility for the import drug registration issues

14. Application Dossier • Part I: General data and Administrative Documents • Part II: Pharmaceutical Data • Part III: Pharmacological and Toxicological data • Part IV: Clinical Data

15. General Approval Procedure Applicant Dossier Required Provincial DAs Refused CDE Technical Evaluation Assessment Report CT Report DDR Rejected CT Approved Director General -Approval No. -Specifications -SPC MA Approved

16. Evaluation and Approval Timeline • 1. Provincial DA Primary Evaluation: 35 days • 2. Provincial QC lab’s tests :60 days; Bio-product: 90 days • 3. CDE technical Evaluation for CTA: 120 days • (Fast-track: 100 days) • 4. CDE technical Evaluation for new drug production application: • 120 days (Fast-track: 100 days) • 5. CDE technical Evaluation for generics: 80 days • 6. CDE technical Evaluation for variations: 40 days • 7. SFDA marketing approval: 30 days

17. Registration Decisions • 1. Approval • 2. Approval with conditions • 3. Rejection • 4. Withdrawal

18. Differences between Import and Domestic Drug Registration Application procedure: provincial DA vs. SFDA Testing labs: provincial QC lab vs. port QC lab R&D site inspection and sample collection Testing of samples used for clinical trial: applicant test vs. port QC lab test Approval certificate: approval number vs. IDL.

19. Fast Track TCM derived from herb, animal, and mineral that have never been previously used as therapeutics New chemical entity (NCE) Anti-HIV/AIDS products (treatment, prevention, Diagnosis) Products for malignant tumor Products for rare diseases (orphan drugs) Products for the diseases that efficacious treatment are not available yet

20. Figure of Clinical Trial Approval(2001-2003) *For pharmaceuticals, the figure includes BA/BE

21. Figure of Marketing Approval(2001-2003)

22. Information Availability • All drug list available on SFDA web site upon its approving • All approved insert sheet and drug specification are sent to Provincial DA and QC Labs • All approved drug published annually • “Import Drug List” • “Domestic New Drug List” • SPC of past approved drug are all on NICPBP web, and published as well.

23. Strict system of drug registration and approval • GMP certification is mandatory for drug manufacturers • Newly promulgated regulations

24. Timetable for GMP compliance： The end of 1998, blood product; The end of 2000, lvp, powder for injection; The end of 2002, svp; June 30, 2004, drugs of all dosage forms and API for human use.

25. Progress of Inspection By the end of 2004 , GMP certification Certified: 4,000; Failed: 1071 ( stopped manufacturing since July 1st, 2004. )

26. Inspection for Drug Manufacturers(by December 31, 2004)

27. Strict system of drug registration and approval • GMP certification is mandatory for drug manufacturers • Newly promulgated regulations

28. Regulation for distribution and vaccination of vaccines come into effect since June 1st, 2005

29. Regulation for psychotropic and narcotic drugs9 chapters, 88 articlesshallcome into effect since November 1st, 2005

30. SFDA web site http://www.sfda.gov.cn My email: chenxy@sda.gov.cn

31. Thank you!