an overview of sfda and current drug administration in china
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An Overview of SFDA and Current Drug Administration in China. Chen Xingyu State Food and Drug Administration , September 6, 2005. Introduction – the SFDA. Founded on the basis of the State Drug Administration (SDA) in 2003 Directly under the State Council - PowerPoint PPT PresentationTRANSCRIPT
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An Overview of SFDA and Current An Overview of SFDA and Current Drug Administration Drug Administration
in Chinain China
Chen Xingyu State Food and Drug Administration,
September 6, 2005
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Introduction – the SFDAIntroduction – the SFDA
Founded on the basis of the State Drug Administration (SDA) in 2003
Directly under the State CouncilIn charge of comprehensive supervision
on the food safety management The national regulatory authority of
drug and medical device
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Drug Administration System Drug Administration System in Chinain China
State Council
SFDA
Drug Administration at provincial level
Drug Administration at city level
Drug Administration at county level
Affiliated Technical
Institutions
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Affiliated Technical InstitutionsAffiliated 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
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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
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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
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Approved by State
Council, and came
into force from Sep.
15, 2002
《《 Regulation for Regulation for Implementation of the Implementation of the Drug Administration Drug Administration Law of P.R. ChinaLaw of P.R. China 》》
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Strict system of drug registration Strict system of drug registration and approval and approval
GMP certification is mandatory GMP certification is mandatory for drug manufacturersfor drug manufacturers
Newly promulgated regulationsNewly promulgated regulations
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Drug Registration LegislationDrug Registration Legislation
1. Drug Administration Law of P.R. China (Amended, 2001.12.01)2. Regulations for Implementation of the Drug Administration Law of P.R. China (Amended, 2002.09.15)3. Provisions for Drug Registration (Amended, 2005.2.28)
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Requirements for Drug Requirements for Drug RegistrationRegistration
1. 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.
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Classification of Drug ApplicationClassification of Drug Application
1. 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
2. Generics: drugs with official standards issued by SFDA (already marketed in China).
3. Import drugs: Manufactured abroad, to be marketed in China.
4. Supplementary application: for variations of already approved drugs.
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Pre-conditions as Import DrugPre-conditions as Import DrugPre-conditions as Import DrugPre-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
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Import Drug ApplicantImport Drug ApplicantImport Drug ApplicantImport 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
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Application DossierApplication Dossier
•Part I: General data and Administrative Documents
•Part II: Pharmaceutical Data
•Part III: Pharmacological and Toxicological data
•Part IV: Clinical Data
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General Approval ProcedureGeneral Approval Procedure
ApplicantApplicant
Provincial DAsProvincial DAs
Dossier RequiredDossier Required
Director GeneralDirector General
CT ApprovedCT ApprovedRejectedRejected
CDE
Technical Evaluation
CDE
Technical Evaluation
RefusedRefused
MA ApprovedMA Approved
CT ReportCT Report
DDR
Assessment Report
-Approval No. -Specifications -SPC
-Approval No. -Specifications -SPC
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Evaluation and Approval TimelineEvaluation 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
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Registration DecisionsRegistration Decisions
• 1. Approval
• 2. Approval with conditions
• 3. Rejection
• 4. Withdrawal
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Differences between Import and Differences between Import and Domestic Drug RegistrationDomestic Drug Registration
1. Application procedure: provincial DA vs. SFDA
2. Testing labs: provincial QC lab vs. port QC lab
3. R&D site inspection and sample collection
4. Testing of samples used for clinical trial:
applicant test vs. port QC lab test
5. Approval certificate: approval number vs. IDL.
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Fast TrackFast Track
1. TCM derived from herb, animal, and mineral that have never been previously used as therapeutics
2. New chemical entity (NCE)3. Anti-HIV/AIDS products (treatment,
prevention, Diagnosis)4. Products for malignant tumor5. Products for rare diseases (orphan drugs)6. Products for the diseases that efficacious
treatment are not available yet
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Figure of Clinical Trial ApprovalFigure of Clinical Trial Approval (2001-2003)(2001-2003)
2001 2002 2003
Pharmaceuticals 593 685 3575*
TCM 282 207 541
Bio-Product 47 49 106
Import Drug 60 61 85
Total 982 1001 4307
* For pharmaceuticals, the figure includes BA/BE
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Figure of Marketing ApprovalFigure of Marketing Approval (2001-2003) (2001-2003)
2001 2002 2003
Pharmaceuticals 796 640 1936
TCM 166 106 311
Bio-Product 115 52 104
Import Drug 657 718 832
Total 1734 1516 3183
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Information AvailabilityInformation 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.
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Strict system of drug registration Strict system of drug registration and approval and approval
GMP certification is mandatory GMP certification is mandatory for drug manufacturersfor drug manufacturers
Newly promulgated regulationsNewly promulgated regulations
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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.
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Progress of InspectionProgress of Inspection
By the end of 2004 , GMP certification
Certified: 4,000;
Failed: 1071
( stopped manufacturing since July 1st, 2004. )
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Inspection for Drug Inspection for Drug ManufacturersManufacturers
((by December 31, 2004)by December 31, 2004)
4000
820251 GMP已认证
Certi fi cated
Need需要检查to bei nspected
Qui t放弃认证
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Strict system of drug registration Strict system of drug registration and approval and approval
GMP certification is mandatory GMP certification is mandatory for drug manufacturersfor drug manufacturers
Newly promulgated regulationsNewly promulgated regulations
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Regulation for distribution and Regulation for distribution and vaccination of vaccines vaccination of vaccines
come into effect since June 1st, 2005come into effect since June 1st, 2005
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Regulation for psychotropic and Regulation for psychotropic and narcotic drugsnarcotic drugs
9 chapters, 88 articles9 chapters, 88 articles
shallshall come into effect since November 1st, 2005come into effect since November 1st, 2005
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Thank you!Thank you!