overview on registration administration of traditional ... · of p.r. china (amended, 2002.09.15)...

Overview on Registration Administration of Overview on Registration Administration of

Traditional Chinese Medicines (TCM) in ChinaTraditional Chinese Medicines (TCM) in China

中国中药注册监管概况中国中药注册监管概况

ZHANGZHANG WeiWei

Department of Drug RegistrationDepartment of Drug RegistrationState Food & Drug Administration of ChinaState Food & Drug Administration of China

2008.92008.9

OutlineOutline

1. Laws and Regulations System for TCM and Natural Medicinal 1. Laws and Regulations System for TCM and Natural Medicinal Products RegistrationProducts Registration

2. Requirements for TCM and Natural Medicinal Products 2. Requirements for TCM and Natural Medicinal Products Registration Registration

3. Supplementary Rules for TCM Registration 3. Supplementary Rules for TCM Registration 4. Standards of TCM4. Standards of TCM

1. 1. 中药和天然药注册管理的相关法规体系中药和天然药注册管理的相关法规体系

2. 2. 中药和天然药注册审评技术要求中药和天然药注册审评技术要求

3. 3. 中药注册管理补充规定的内容中药注册管理补充规定的内容

4. 4. 中药标准管理中药标准管理

Drug Administration Law of P.R. Drug Administration Law of P.R. ChinaChina

(Amended, 2001.12.01)(Amended, 2001.12.01)

Regulations for Implementation Regulations for Implementation of the Drug Administration Law of the Drug Administration Law of P.R. Chinaof P.R. China(Amended, 2002.09.15)(Amended, 2002.09.15)

Regulations for the Protection Regulations for the Protection of TCM Productsof TCM Products(1993.01.01)(1993.01.01)

Drug Laws and Regulations in ChinaDrug Laws and Regulations in China国家药品监管法规国家药品监管法规

药品管理法药品管理法

（（20012001年年1212月月11日修订）日修订）

药品管理法实施条例药品管理法实施条例

（（20022002年年99月月1515日实施）日实施）

中药品种保护条例中药品种保护条例

（（19931993年年11月月11日实施）日实施）

药品Drug

化学药品Chemical drug

生物制品Biological product

中药和天然药物Traditional Chinese Medicine

and Natural drug

SFDA order 28SFDA order 28————Provision for Drug Provision for Drug RegistrationRegistrationSFDA order 27SFDA order 27————Provision for Drug Provision for Drug Advertisement ReviewAdvertisement ReviewSFDA order 26SFDA order 26————Provision for Drug Provision for Drug Circulation AdministrationCirculation AdministrationSFDA order 24SFDA order 24————Provisions for Drug Provisions for Drug Instruction and Label Instruction and Label SFDA order 22SFDA order 22————Provisions for Drug Provisions for Drug ImportationImportationSFDA order 21SFDA order 21————Special Review and Special Review and Approval Procedure for Drug Approval Procedure for Drug Registration Registration SFDA order 20SFDA order 20————Provisions for Provisions for Medical Institution Pharmaceutical Medical Institution Pharmaceutical Preparations RegistrationPreparations Registration

Series of State Food & Drug Administration OrderSeries of State Food & Drug Administration Order国家食品药品监管局局令国家食品药品监管局局令

局令第局令第2828号号————药品注册管理办药品注册管理办法法

局令第局令第2727号号————药品广告审查办药品广告审查办法法

局令第局令第2626号号————药品流通监督管药品流通监督管理办法理办法

局令第局令第2424号号————药品标签和说明药品标签和说明书管理规定书管理规定

局令第局令第2222号号————进口药材管理办进口药材管理办法（试行）法（试行）

局令第局令第2121号号————药品特别审批程药品特别审批程序序

局令第局令第2020号号————医疗机构制剂注医疗机构制剂注册管理办法（试行册管理办法（试行））

《《药品注册管理办法药品注册管理办法》》自自19851985年制定以来，于年制定以来，于19991999、、20022002、、20052005和和20072007年经过四次较大规模修订，最新版本于年经过四次较大规模修订，最新版本于20072007年年1010月月11日生效。日生效。

PProvisions for rovisions for DDrug rug RRegistrationegistration《《药品注册管理办法药品注册管理办法》》

The newly revised The newly revised Provisions for Drug Registration Provisions for Drug Registration takes takes

effect since Oct. 1st, 2007.effect since Oct. 1st, 2007.

The Chapter ofThe Chapter of PDRPDR《《药品注册管理办法药品注册管理办法》》的内容的内容

1.1. 总则总则

2.2. 基本要求基本要求

3.3. 药物的临床试验药物的临床试验

4.4. 新药申请的申报与审批新药申请的申报与审批

5.5. 仿制药的申报与审批仿制药的申报与审批

6.6. 进口药品的申报与审批进口药品的申报与审批

7.7. 非处方药的申报非处方药的申报

8.8. 补充申请的申报与审批补充申请的申报与审批

9.9. 药品再注册药品再注册

10.10. 药品注册检验药品注册检验

11.11. 药品注册标准和说明书药品注册标准和说明书

12.12. 时限时限

13.13. 复审复审

14.14. 法律责任法律责任

15.15. 附则附则

I.I. General ProvisionsGeneral ProvisionsII.II. Application for Drug RegistrationApplication for Drug RegistrationIII.III. Drug Clinical TrialsDrug Clinical TrialsIV.IV. Application and Approval of New DrugsApplication and Approval of New DrugsV.V. Application and Approval of Generic DrugsApplication and Approval of Generic DrugsVI.VI. Application and Approval of Import DrugsApplication and Approval of Import DrugsVII.VII. Application of NonApplication of Non--Prescription DrugsPrescription DrugsVIII.VIII. Submission, Review and Approval of Submission, Review and Approval of

Supplementary ApplicationSupplementary ApplicationIX.IX. Drug ReDrug Re--RegistrationRegistrationX.X. Testing for Drug RegistrationTesting for Drug RegistrationXI.XI. Drug Registration Specifications and Insert SheetDrug Registration Specifications and Insert SheetXII.XII. TimelineTimelineXIII.XIII. Second ReviewSecond ReviewXIV.XIV. Legal LiabilitiesLegal LiabilitiesXV.XV. Supplementary ProvisionsSupplementary Provisions

Main Parts of the Registration ProcedureMain Parts of the Registration Procedure药品注册审批程序的主要环节药品注册审批程序的主要环节

Acceptance of application dossierAcceptance of application dossier

OnOn--site inspection of drug research site inspection of drug research and the original dataand the original data

Technical reviewTechnical review

Verification of drug quality Verification of drug quality standards and inspection of standards and inspection of sample productionsample production

OnOn--site inspection of production site inspection of production sitesite

General opinionGeneral opinion

Administration approvalAdministration approval

受理申报资料受理申报资料::审核资料完整性审核资料完整性

现场核查现场核查::考察资料真实性考察资料真实性,,规范性规范性

技术审评技术审评：基于提供的研究资料评：基于提供的研究资料评价其安全性、有效性、质量。价其安全性、有效性、质量。

标准复核和样品检验标准复核和样品检验：评价检验方：评价检验方法的可行性、科学性，检验样品是法的可行性、科学性，检验样品是否合格否合格

生产现场检查生产现场检查::检查生产条件和工检查生产条件和工艺可行性艺可行性,,动态抽样动态抽样

综合审评综合审评：汇总技术审评意见、生：汇总技术审评意见、生产现场检查报告和样品检验结果，产现场检查报告和样品检验结果，形成综合意见形成综合意见

行政审批行政审批

1. Laws and Regulations System for TCM and Natural Medicinal 1. Laws and Regulations System for TCM and Natural Medicinal Products Registration Products Registration

2. Requirements for TCM and Natural Medicinal Products 2. Requirements for TCM and Natural Medicinal Products Registration Registration






Technical Requirement for TCM and Natural Medicinal Technical Requirement for TCM and Natural Medicinal ProductsProducts

中药和天然药物注册管理的技术要求中药和天然药物注册管理的技术要求

Provisions for Drug Registration Provisions for Drug Registration Annex 1Annex 1：：Registration Registration

Categories and Application Categories and Application Dossier Requirements for Dossier Requirements for Traditional Chinese Medicines Traditional Chinese Medicines and Natural Medicinal Productsand Natural Medicinal Products

Supplementary Rules for TCM Supplementary Rules for TCM Registration (2008.01.07)Registration (2008.01.07)

Series of Technical Guideline for Series of Technical Guideline for TCM and Natural Medicinal TCM and Natural Medicinal Products RegistrationProducts Registration

《《药品注册管理办法药品注册管理办法》》附件一附件一““中药、天然药物注册分类及资料中药、天然药物注册分类及资料要求要求””

《《中药注册管理补充规定中药注册管理补充规定》》

20082008年年11月月77日实施日实施

《《中药、天然药物注册技术指导中药、天然药物注册技术指导原则原则》》系列系列

The Requirements of Dossier for Registration of TCM and The Requirements of Dossier for Registration of TCM and Natural Medicinal Products Natural Medicinal Products 中药中药和天然药物和天然药物注册申报资料要求注册申报资料要求

1. 1. 综述综述

2. 2. 药学研究资料药学研究资料

药材来源及鉴定药材来源及鉴定

栽培栽培

加工加工

炮制方法炮制方法

生产工艺生产工艺

质量研究实验数据质量研究实验数据

质量标准质量标准

稳定性研究等稳定性研究等

1 . General information1 . General information2 . Files of pharmaceutical 2 . Files of pharmaceutical

researchresearchorigin & its identification of Chinese origin & its identification of Chinese materialmaterial medicamedicacultivation, preparing method or cultivation, preparing method or processing of slicesprocessing of slicesproduction processproduction processquality testing dataquality testing dataquality standard as well as stability quality standard as well as stability testtestetc..etc..

The Requirements of Dossier for Registration of TCM and The Requirements of Dossier for Registration of TCM and Natural Medicinal ProductsNatural Medicinal Products中药中药和天然药物和天然药物注册申报资料要求注册申报资料要求

3 . 3 . 药理毒理研究资料药理毒理研究资料药效学试验药效学试验急毒急毒长毒长毒过敏过敏溶血溶血三致试验等三致试验等

4 . 4 . 临床试验资料临床试验资料

临床方案临床方案

伦理委员会批件伦理委员会批件

临床试验报告等临床试验报告等

3 . Files of pharmacological & 3 . Files of pharmacological & toxicological researchtoxicological researchpharmacodynamicspharmacodynamics testtestacute & longacute & long--term toxic studies, allergicterm toxic studies, allergichaemolytichaemolytic testtestcancer causing testcancer causing testetc..etc..

4 . Files of clinical research4 . Files of clinical researchclinical trial clinical trial ethical committee approvalethical committee approvaltesting reporttesting reportetc..etc..

Series of Series of Technical Guidelines for TCM and Natural Technical Guidelines for TCM and Natural Medicinal Products RegistrationMedicinal Products Registration

《《中药、天然药物注册技术指导原则中药、天然药物注册技术指导原则》》系列系列

Technical guideline for preparing method Technical guideline for preparing method of raw materialof raw materialTechnical guideline for extraction and Technical guideline for extraction and purification purification Technical guideline for general Technical guideline for general pharmacologypharmacologyTechnical guideline for acute toxic Technical guideline for acute toxic studiesstudiesTechnical guideline for longTechnical guideline for long--term toxic term toxic studiesstudiesTechnical guideline for allergic andTechnical guideline for allergic andhaemolytichaemolytic testtestTechnical guideline for immune toxic Technical guideline for immune toxic studiesstudiesTechnical guideline for stability studyTechnical guideline for stability studyTechnical guideline for preparation studyTechnical guideline for preparation studyTechnical guideline for writing dossiersTechnical guideline for writing dossiersetc..etc..

原料前处理技术指导原则原料前处理技术指导原则

提取纯化工艺研究技术指导原提取纯化工艺研究技术指导原则则

一般药理学研究技术指导原则一般药理学研究技术指导原则

急性毒性技术指导原则急性毒性技术指导原则

长期毒性技术指导原则长期毒性技术指导原则

刺激性和溶血性技术指导原则刺激性和溶血性技术指导原则

免疫毒性技术指导原则免疫毒性技术指导原则

稳定性研究技术指导原则稳定性研究技术指导原则

制剂研究技术指导原则制剂研究技术指导原则

综述撰写原则综述撰写原则

等等等等

Series of Series of Technical Guidelines for TCM and Natural Technical Guidelines for TCM and Natural Medicinal Products RegistrationMedicinal Products Registration

《《中药、天然药物注册技术指导原则中药、天然药物注册技术指导原则》》系列系列

Review standard and Guideline for TCM Review standard and Guideline for TCM application with undefined quality application with undefined quality standardstandardReview guideline for TCM application Review guideline for TCM application containing Rare and Endangered containing Rare and Endangered Medicinal MaterialsMedicinal MaterialsReview guideline for Issues Related to Review guideline for Issues Related to TCM production processTCM production processReview guideline for TCM application Review guideline for TCM application with containing toxic Materials or with with containing toxic Materials or with security Issues questionsecurity Issues questionTechnical requirement for the rationality Technical requirement for the rationality of Formulation Selection of TCM dosage of Formulation Selection of TCM dosage changing applicationchanging applicationReview guideline for Issues Related to Review guideline for Issues Related to TCM product for external useTCM product for external useReview guideline for Issues Related to Review guideline for Issues Related to TCM quality control studyTCM quality control study

中药质量标准不明确的判定标准及处理中药质量标准不明确的判定标准及处理

原则原则

含濒危药材中药品种处理原则含濒危药材中药品种处理原则

中药工艺相关问题的处理原则中药工艺相关问题的处理原则

含毒性药材及其他安全性问题中药品种含毒性药材及其他安全性问题中药品种

的处理原则的处理原则

中药改剂型品种剂型选择合理性的技术中药改剂型品种剂型选择合理性的技术

要求要求

中药外用制剂相关问题的处理原则中药外用制剂相关问题的处理原则

中药质量控制研究相关问题的处理原则中药质量控制研究相关问题的处理原则

Concerns on Review and Aproval 技术审评和行政审批的关注事项技术审评和行政审批的关注事项

To evaluate the safety, efficacy and To evaluate the safety, efficacy and quality control based on dossier quality control based on dossier submitted submitted

Clinical trialClinical trial

Risk/Benefits Analysis

Public health needs

Marketing value (Access to essential Marketing value (Access to essential medicine, etc)medicine, etc)Strictly evaluate the influence on Strictly evaluate the influence on ecological environment so as to keep ecological environment so as to keep sustainable utilization of resourcesustainable utilization of resourceThe national pharmacy development The national pharmacy development programming and industry policy programming and industry policy

基于申报资料对安全性、有效

性、质量可控性进行评估

临床试验

分析风险效益比

关注公众健康利益需求

上市价值评估(药物可及性等)

强调对资源的可持续利用及对

环境保护影响

国家药品行业发展规划和产业

政策


2. Requirements for TCM and Natural Medicinal Products 2. Requirements for TCM and Natural Medicinal Products RegistrationRegistration






Supplementary Rules for TCM Registration New!New!

《《中药注册管理补充规定中药注册管理补充规定》》

Drug

Chemical drug Biological productTCM and natural medicinal products

中药是指在中国传统中医药理论指导下使用的药用物质及其制剂.

TCM refer to medicinal materials and their preparations based on the Chinese traditional medicine theories.

天然药物是指在现代医药理论指导下使用的天然药用物质及其制剂

Natural medicinal products refer to natural medicinal materials and their preparations based on the modern medical theory .

Supplementary Rules for TCM Registration

Supplementary Supplementary Rules for Rules for TCM TCM RegistrationRegistration

PDRPDR

Reflect the Characteristics and Advantages of TCM Reflect the Characteristics and Advantages of TCM 体现中医药的特色和优势体现中医药的特色和优势

According to the characteristics and advantages of TCM, TCM combination preparations was classified as follows：

TCM combination preparations originated from historic, classic and originated from historic, classic and wellwell--known recipesknown recipesTCM combination preparations whose indication is a TCM whose indication is a TCM syndromesyndromeTCM combination preparations whose indication is a combination whose indication is a combination of TCM syndrome and diseases.of TCM syndrome and diseases.

依据中医药特色和优势依据中医药特色和优势,,对对中药复方制剂进行了分类中药复方制剂进行了分类6.1.1 6.1.1 来源于古代经典名方的中药复方制剂来源于古代经典名方的中药复方制剂

6.1.2 6.1.2 主治为证候的中药复方制剂主治为证候的中药复方制剂

6.1.36.1.3 主治为病症结合的中药复方制剂主治为病症结合的中药复方制剂

Emphasize on the Clinical Treatment Experiences of Emphasize on the Clinical Treatment Experiences of TCM RecipesTCM Recipes

注重中药的临床应用经验注重中药的临床应用经验

对来源于古代经典名方的中药复方制剂，根据临床应用历史和经验、处方来对来源于古代经典名方的中药复方制剂，根据临床应用历史和经验、处方来源、功能主治、制备工艺等情况，适当减免临床前研究和临床研究要求。源、功能主治、制备工艺等情况，适当减免临床前研究和临床研究要求。

必须进行安全性研究，严把安全关。必须进行安全性研究，严把安全关。

The application data for marketing TCM combination The application data for marketing TCM combination preparationspreparations may be partially exempted based on formulation may be partially exempted based on formulation source and their composition, function and indication, and source and their composition, function and indication, and manufacturing procedures.manufacturing procedures.Toxicology test research must be carried out for all TCM Toxicology test research must be carried out for all TCM combination preparations registration application. combination preparations registration application.

Encourage the TCM Innovation and DevelopmentEncourage the TCM Innovation and Development鼓励中药创新和发展鼓励中药创新和发展

丰富了中药复方制剂的内涵丰富了中药复方制剂的内涵,,鼓励中药创新和发展。鼓励中药创新和发展。

在传统以中药饮片组方的基础上，允许提取物、有效部位、有效成分在传统以中药饮片组方的基础上，允许提取物、有效部位、有效成分

纳入中药复方制剂的组方中。纳入中药复方制剂的组方中。

The content of TCM combination preparations was The content of TCM combination preparations was developed. developed.

A TCM combination preparations may consist of extractives, A TCM combination preparations may consist of extractives, active fraction and/or active ingredient besides the traditionalactive fraction and/or active ingredient besides the traditionalprepared slices of Chinese crude drugs.prepared slices of Chinese crude drugs.

Encourage the TCM Innovation and DevelopmentEncourage the TCM Innovation and Development鼓励中药创新和发展鼓励中药创新和发展

Reasonably modulate the items of TCM dossier submittedReasonably modulate the items of TCM dossier submittedElevate the technical requirement for changing the dose form andElevate the technical requirement for changing the dose form andgeneric TCM applicationgeneric TCM applicationReasonably modulate the registration dossier for changing Reasonably modulate the registration dossier for changing adjuvant materials and changing the manufacturing technology adjuvant materials and changing the manufacturing technology application application Better clinical trial with placebo or/and drug controlledBetter clinical trial with placebo or/and drug controlled

遵从中药研制特点和规律，合理调整了相关技术要求遵从中药研制特点和规律，合理调整了相关技术要求提高中药改剂型、仿制药注册申请的技术要求提高中药改剂型、仿制药注册申请的技术要求合理调整改辅料、改工艺等注册申请的技术要求合理调整改辅料、改工艺等注册申请的技术要求强调临床试验的对照研究强调临床试验的对照研究

Enhance the Quality Control of TCMEnhance the Quality Control of TCM加强中药质量控制加强中药质量控制

Enhance quality stability control Enhance quality stability control Enhance quality control by Enhance quality control by ““to control the source of the rawto control the source of the rawmateriamateria””, , ““to control the manufacture processto control the manufacture process”” and and ““test controltest control””Strictly evaluate the influence on ecological environment so as Strictly evaluate the influence on ecological environment so as to to keep sustainable utilization of resource.keep sustainable utilization of resource.

强调中药质量的均一稳定强调中药质量的均一稳定强调全过程监管：强调全过程监管：””源头控制源头控制““、、””过程控制过程控制““、、””指标控制指标控制““

强调对资源的可持续利用及对环境保护影响强调对资源的可持续利用及对环境保护影响


2. Technical Requirements for TCM and Natural Medicinal Product2. Technical Requirements for TCM and Natural Medicinal Products s Registration Registration






Drug Standards System in ChinaDrug Standards System in China中国药品标准体系中国药品标准体系

National drug standardsNational drug standardsPharmacopoeia of P.R.ChinaPharmacopoeia of P.R.ChinaSpecification approved by Specification approved by SFDASFDA

Provincial standards Provincial standards Monographs of ChineseMonographs of ChineseMateria MedicaMateria Medica and process of and process of TCM slices approved by local TCM slices approved by local provincesprovinces

国家药品标准国家药品标准

中国药典中国药典

部局颁标准部局颁标准

省级地方药材标准省级地方药材标准

各省（自治区、直辖市）中药材各省（自治区、直辖市）中药材药品标准、中药饮片炮制规范药品标准、中药饮片炮制规范

Chinese PharmacopoeiaChinese Pharmacopoeia中国药典中国药典

Modern development in quality Modern development in quality standards of TCM leaves standards of TCM leaves footprints in different versions footprints in different versions of Chinese Pharmacopoeia, of Chinese Pharmacopoeia, especially in the improvement of especially in the improvement of quality control.quality control.

Chinese PharmacopoeiaChinese Pharmacopoeia edition edition

1953,1963,1977,1985,1990,1995, 1953,1963,1977,1985,1990,1995,

2000,2005 issued.2000,2005 issued.

中国中药质量标准的发展可以中国中药质量标准的发展可以

每一版每一版《《中国药典中国药典》》为主线，为主线，

特别是质量控制方面。特别是质量控制方面。

《《中国药典中国药典》》先后颁布了先后颁布了19531953

版版,1963,1963版版,1977,1977版版,1985,1985

版版,1990,1990版版,1995,1995版版,2000,2000版及版及

现行的现行的20052005版。版。

Chinese Materia and Prepared Slices of Chinese Crude DrugsOil, Fats and Extractives Traditional Chinese Patent Medicines, Simple Preparations 药材及饮片、植物油脂和提取物、成药药材及饮片、植物油脂和提取物、成药 ———— 中中药药

Chemicals, RadiopharmaceuticalsBiochemicals, ExcipientsAntibiotics 化学药品化学药品

Biological Products 生物制品生物制品Volume Ⅲ

Chinese Pharmacopoeia (2005) Content Chinese Pharmacopoeia (2005) Content 20052005版中国药典内容版中国药典内容

Volume Ⅰ

Volume Ⅱ

The ninth State Pharmacopoeia Committee was set up in Dec 2007 for the compilation of Chinese Pharmacopoeia (2010)

The following special committees related to TCM were set up

Special Committee of Ethnic MedicinesSpecial Committee of TCMSpecial Committee of Chinese Medicinal Materials and Prepares Slices of Chinese Crude DrugsSpecial Committee of Traditional Chinese Patent MedicinesSpecial Committee of Natural Drug

2007年12月成立了第九届药典委员会,开始2010版《中国药典》的编制工作。

加强中药（民族药、天然药）相关机构设置，包括：

民族医药专业委员会

中医专业委员会

中药材与饮片专业委员会

中成药专业委员会

天然药物专业委员会

Chinese Pharmacopoeia (2010) StartupChinese Pharmacopoeia (2010) Startup20102010版中国药典启动版中国药典启动

Goal of volume Goal of volume II in Chinese Pharmacopoeia (2010)in Chinese Pharmacopoeia (2010)20102010版中国药典一部的编制工作目标版中国药典一部的编制工作目标

To comprehensively improve and perfect the quality standards of Chinese traditional medicine（including ethnic medicines ）and prepared slice of Chinese crude drug.

To establish a quality control system, which is adapted to the characters of TCM, gradually change from single ingredient test to combination test of active ingredient and bioassay, and to macro quality control mode including multi-components, fingerprint and character chromatogram.

To add and perfect the safety test methods of TCM, enhance the specificity of test methods, and establish scientific and reasonable control indexes.

全面提高和完善中药材（包括民族药）、中药饮片质量标准，

建立符合中医药特点的质量标准体系，逐步由单一指标性成分定性定量向活性、有效成分及生物测定的综合检测过渡，向多成分及和指纹或特征图谱整体质量控制模式转化。

重点增加和完善中药安全性检测方法，增强检测方法的专属性，建立科学合理的控制指标。

Drug Standards Improvement Action (2006Drug Standards Improvement Action (2006--2010)2010)药品标准提高行动药品标准提高行动(2006(2006--2010)2010)

TCMTCMTo improve the standards of To improve the standards of 4000 TCM specification 4000 TCM specification approved by SFDAapproved by SFDATo establish or revise To establish or revise national standards of 1000 national standards of 1000 Chinese crud Drug Chinese crud Drug To establish or revise To establish or revise national standards of 500 national standards of 500 Prepares Slices of Chinese Prepares Slices of Chinese Crude DrugsCrude Drugs

中药方面中药方面

提高提高40004000个品种的部颁标准个品种的部颁标准

制定修订制定修订10001000种中药材的国家种中药材的国家

标准标准

制定修订制定修订500500种中药饮片的国种中药饮片的国

家标准家标准

Administration of Adverse Drug Reaction of TCMAdministration of Adverse Drug Reaction of TCM中药不良反应监测中药不良反应监测

国家药品评价中心负责监国家药品评价中心负责监测测包括中药在内的所有药包括中药在内的所有药品的不良事件，及时发布品的不良事件，及时发布不良反应信息。不良反应信息。

通过修订药品说明书促进通过修订药品说明书促进合理用药。合理用药。

通过再评价淘汰安全隐患通过再评价淘汰安全隐患大的品种。大的品种。

及时控制、撤市和召回高及时控制、撤市和召回高风险产品。风险产品。

Center for Drug Reevaluation is Center for Drug Reevaluation is in charge of adverse drug in charge of adverse drug reaction (ADR) monitoring and reaction (ADR) monitoring and reporting.reporting.

To revise the instruction based To revise the instruction based on ADR and promote rational use on ADR and promote rational use of TCM .of TCM .

To cancel the risked TCM To cancel the risked TCM products by reevaluation after products by reevaluation after marketing.marketing.

To timely control, withdraw and To timely control, withdraw and recall the TCM products with recall the TCM products with high riskshigh risks..

Concluding RemarksConcluding Remarks总总结结

中国对中药的监管和化学药品、生物制品同样严格。

中药质量的控制和标准日趋合理和严格。

中药注册需要进行严格的技术审评和临床试验。

建立长期交流机制，促进信息共享。

In China, the supervision on TCM is as strict as that of chemical drugs and biological products.

Rationality and strictness of quality control and standards of TCM are continuously.

Registration of TCM shall be subject to strict technical evaluation and clinic trial.

Set up long-term communication mechanism to promote information sharing.

overview on registration administration of traditional ... · of p.r. china (amended, 2002.09.15)...

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