An Overview of SFDA and Current Drug Administration in China

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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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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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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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SFDA web site

http://www.sfda.gov.cn

My email:[email protected]

http://www.sfda.gov.cn/

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Thank you!Thank you!