International Conference on Harmonisation

指南

Development Safety Update Report; E2F: 步 4, 八月 2010 (PDF334KB)
临床研究报告的结构和内容; E3: 十一月 1995 (PDF471KB)
良好的临床实践; E6(R1): 步 4, 六月 1996 (PDF380KB; 包括ibtemplate)
临床试验的一般考虑; E8: 七月 1997 (PDF182KB)
临床安全数据管理: 快速报告的定义和标准; E2A: 步 4, 十月 1994 (PDF145KB)
Statistical Principles for Clinical Trials; E9: 2月 1998 (PDF284KB)
Validation of Analytical Procedures – Text and Methodology; Q2(R1): 步 4, 十一月 2005 (PDF180KB)
Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products – Chemical Substances; Q6A: 十月 1995 (PDF211KB, Decision Trees PDF46KB)
All documents are in step 5 (implementation state) unless noted otherwise.
世界卫生组织

药物
Guidelines for GCP for trials on pharmaceutical products (WHO Technical Report Series No. 850, 附件 3): 1995 (PDF104KB)
Handbook for GCP: 2005 (PDF560KB)
Prequalification Programme
Information for Applicants: 指南: 仿制药
Main text: Guideline on Generics – Pharmaceutical Quality and BE(333KB PDF); selected annex and supplement below.
附件 7, Presentation of BE Trial Information (BTIF): 扬 2010(DOC440KB, ZIP/DOC245KB), 八月 2005 (DOC424KB, ZIP/DOC244KB)
Supplement 1 (Dissolution testing): 七月 2005 (PDF103KB)
Guideline on the Requalification of Prequalified Dossiers: Draft Mar 2009 (PDF69KB)
Multisource (Generic) Products: 1998 (PDF666KB)
Multisource (Generic) Products: Draft Revision, 2005 (PDF277KB)
International Comparator: Draft Revision, 2005 (PDF142KB)
Biowaiver: Draft 2005 (PDF197KB)
Guidance for Organizations performing in vivo Bioequivalence Studies: Draft 2005 (PDF103KB)
WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-ninth Report (WHO TRS No. 929, 附件 5); Fixed dose combinations: 六月 2005 (PDF974KB)
WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fortieth Report (WHO TRS No. 937): 可能 2006 (PDF1.9MB); Annexes 7–9 are available in separate documents:
附件 7: Multisource (generic) 药品: guidelines on registration requirements to establish interchangeability (PDF425KB)
附件 8: Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms (PDF464KB)
附件 9: Additional guidance for organizations performing in vivobioequivalence studies (PDF371KB)
WHO Expert Committee on Biological Standardization; Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs): 十月 2009 (PDF256KB)
Handbook Good Laboratory Practice (GLP): 2001 (PDF1.1MB)
Training manual for the trainer: 2001 (chapters as PDFs)
Training manual for the trainee: 2001 (chapters as PDFs)
欧洲联盟 (EMA)

EudraLex – The Rules Governing Medicinal Products in the European Union
Please note: EMA redesigned the website on July 15, 2010.
Links to documents marked with an asterisk* are broken as of Jul 8, 2011. Copies available at our site are denoted by this icon: .
Procedure for European Union Guidelines and Related Documents within the Pharmaceutical Legislative Framework: 扬 2009 (PDF102KB)
指南: Clinical Efficacy and Safety HTML, Multidisciplinary HTML
立法
Directive 2001/20/EC (Implementation of GCP in the Conduct of Clinical Trials on Medicinal Products for Human Use): 4月 2001 (PDF152KB)
Directive 2003/94/EC (Principles and Guidelines of GMP in Respect of Medicinal Products for Human Use and Investigational Medicinal Products for Human Use): 十月 2003 (PDF115KB)
Directive 2004/9/EC (Inspection and Verification of GLP): 2月 2004 (in many European languages and formats [HTML, PDF, TIFF], 例如。, PDF247KBen)
Directive 2004/10/EC (Harmonisation of Laws, Regulations and Administrative Provisions relating to the Application of the Principles ofGLP and the Verification of their Applications for Tests on Chemical Substances): 2月 2004 (in many European languages and formats [HTML, PDF, TIFF], 例如。, PDF239KB en)
Directive 2005/28/EC (Principles and detailed Guidelines for GCP as regards IMPs for Human Use, as well as the Requirements for Authorisation of the Manufacturing or Importation of such Products): 4月 2005 (PDF66KB)
Requirements to the Chemical and Pharmaceutical Quality Documentation concerning IMPs in Clinical Trials: Mar 2006 (PDF141KB)
Definition of IMPs and NIMPs: 七月 2006 (PDF51KB)
Additional Information on IMPs: 4月 2007 (PDF41KB)
GMP, Medicinal Products for Human and Veterinary Use, 附件 13, 小鬼: 扬 2010 (PDF66B)
Bioavailability / 生物等效性
Note for Guidance and associated documents
生物等效性: 扬 2010 (PDF236KB), Overview of comments Jan2010 (PDF1.5MB) Draft Jul 2008 (PDF436KB) Recommendation on the Need for Revision of NfG on BA/BE: 可能 2007 (PDF38KB)
Concept paper on the Need to Develop an Appendix to the Guideline on BE Regarding the Presentation of Biopharmaceutical and Bioanalytical Data in Application Dossiers: 4月 2010 (PDF99KB)
Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.7.1new: Draft Feb 2011 (PDF155KB)
问题 & Answers on the BA and BE Guideline: 七月 2006 (PDF118KB PDF)
Bioavailability / Bioequivalence*: 七月 2001 (PDF99KB PDF).
BA/BE for HVDs/HVDPs: 4月 2006; removed in Oct 2007 from EMEA’s site (quote: Deleted – This topic will be addressed in the revision of “Note for guidance on the investigation of bioavailability and bioequivalence”CHMP/EWP/200943/07) PDF36KB.
Concept Paper on BCS-based Biowaiver: 可能 2007 (PDF43KB)
Reflection paper: Advice to Applicants/Sponsors/CROs of BEStudies: Sep 2008 (PDF104KB)
Modified Release Oral / Transdermals: 七月 1999 (PDF122KB)
Concept paper on the need for revision of the note for guidance on modified release oral and transdermal dosage forms: Section II (pharmacokinetic and clinical evaluation): 可能 2010 (PDF78KB)
Concept paper on the need for revision of the note for guidance on modified release oral and transdermal dosage forms: Section I (质量): 七月 2010 (PDF95KB)
药代动力学
Pharmacokinetic Studies in Man: 十月 1988 (PDF39KB)
PK Studies in Patients with Renal Impairment: 六月 2004 (PDF213KB)
Evaluation of the PK of Medicinal Products in Patients with Impaired Hepatic Function: 2月 2005 (PDF92KB)
PK in the Development of Medicinal Products in the Paediatric Population: 六月 2006 (PDF115KB)
Reflection paper: Use of Pharmacogenetics in the PK Evaluation of Medicinal Products: 可能 2007 (PDF61KB)
Concept Paper on the Development of a Guideline on the Use of Pharmacogenomic Methodologies in the PK Evaluation of Medicinal Products: 4月 2009 (PDF53KB)
Reporting Results of Population PK Analyses: 六月 2007 (PDF68KB)
Strategies to Identify and Mitigate Risks for First-In Human Clinical Trials with IMPs: 七月 2007 (PDF83KB)
Statistical Issues
Biostatistical Methodology in Clinical Trials*: 十月 1993 (PDF153KB PDF).
Points to Consider on Multiplicity Issues in Clinical Trials: Sep 2002 (PDF208KB)
Guideline on missing data in confirmatory clinical trials: 七月 2010(PDF142KB) Draft Apr 2009 (PDF99KB) Recommendation for the Revision of the Points to Consider on Missing Data (CPMP/EWP/1776/99): 十二月 2007 (PDF35KB) Points to Consider on Missing Data: 十一月 2001 (PDF38KB)
Biotechnological and Biological Products, Biosimilars
Development Pharmaceutics for Biotechnological and Biological Products – Annex to Note for Guidance on Development Pharmaceutics: 十月 1999 (PDF36KB)
Clinical Investigation of the PK of Therapeutic Proteins: 扬 2007 (PDF98KB, Draft Jul 2005 (PDF101KB)
Similar Biological Medicinal Product: 十月 2005 (PDF106KB)
Q&A on biosimilar medicines: 十月 2008 (PDF30KB)
Biosimilars containing Biotechnology-Derived Proteins as Active Substance: Quality Issues: Sep 2005 (PDF137KB)
Biosimilars containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues: 2月 2006 (PDF102KB)
Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process – Non-Clinical and Clinical Issues: 七月 2007 (PDF118KB) Draft Jan 2007 (PDF171KB) Concept paper Feb 2006 (PDF38KB) Final Dec 2003 (PDF194KB)
Product specific biosimilar guidelines
Recombinant Human Insulin: 2月 2006 (PDF102KB)
Somatropin: 2月 2006 (PDF78KB)
Recombinant Granulocyte-Colony Stimulating Factor: 2月 2006 (PDF89KB)
Recombinant Erythropoietins: 4月 2010 (PDF133KB) Draft Jul 2009(PDF108KB) Concept paper Jul 2008 (PDF43KB) Final Mar 2006 (PDF45KB)
Low-molecular-weight-heparins: Mar 2009 (PDF63KB) Draft Apr 2008 (PDF55KB) Concept paper Jan 2007 (PDF72KB)
Interferon alpha: Reflection paper Jun 2009 (PDF97KB) Draft Oct 2007 (PDF102KB) Concept paper Apr 2006 (PDF72KB)
Immunogenicity assessment of monoclonal antibodies: Concept paper Mar 2009 (PDF39KB)
Monoclonal antibodies: Draft Nov 2010 (PDF192KB)
Follicle stimulation hormone: Concept paper Mar 2010 (PDF125KB)
Interferon beta: Concept paper Mar 2010 (PDF179KB)
Miscellaneous
Q&一个: Positions on specific questions addressed to the Pharmacokinetics Working Party (PKWP): 扬 2011 (PDF195KB) 七月 2010 ( PDF182KB) Jul2009 (PDF89KB PDF) 六月 2009 (PDF94KB PDF) 扬 2009 ( PDF87KB)
Scientific Advice & Protocol Assistance: Revision 6, 可能 2010 (PDF280KB)
Validation of Bioanalytical Methods: Draft Nov 2009 (PDF135KB)Finalisation expected Q3 2011
Concept Paper/Recommendations on the Need for a (CHMP) Guideline on the Validation of Bioanalytical Methods: 十二月 2008 (PDF52KB)
Validation of Analytical Procedures. Text and Terminology: 十一月 1994, 方法论: 十二月 1996 (PDF186KB)
Test on Samples of Biological Origin: 七月 1989 (PDF39KB)
Clinical Investigation of Chiral Active Substances: 4月 1994 (PDF52KB)
Topicals: 十一月 1995 (PDF43KB)
Fixed Combination Medicinal Products: 2月 2009 (PDF92KB)
Drug Interactions: 十二月 1997 (PDF79KB)
Concept Paper/Recommendation on the Need for Revision of NfG on the Investigation of Drug Interactions: 七月 2008 (PDF31KB)
Drug Interactions: Draft Apr 2010 (PDF352KB)
Development Pharmaceutics: 扬 1998 (PDF58KB)

Dry Powder Inhalers*: 六月 1998 (PDF45KB PDF).
Points to Consider on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP): 4月 2004 (PDF159KB)
Recommendation on the Need for Revision of Points

to Consider on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP): 2月 2007 (PDF36KB)
Requirements for Clinical Documentation for Orally Inhaled Products (OIP) including the Requirements for Demonstration of Therapeutic Equivalence between two Inhaled Products for Use in the Treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD): 扬 2009 (PDF271KB), Draft Oct 2007 (PDF176KB), Appendix 1: Mar 2008 (PDF44KB)
Gender Considerations in the Conduct of Clinical Trials: 扬 2005 (PDF75KB)
Guideline on Pharmaceutical Development of Medicines for Paediatric Usenew: Draft May 2011 (PDF247KB)咨询 31 十二月 2011
Inspections – Good Clinical Practice: Set of 13 documents, Sep 2007 – May 2008 (例如。, Investigator Site PDF39KB, Sponsor and/or Contract Research Organisations PDF36KB, Phase I Units PDF31KB, 生物分析部分, Pharmacokinetic and Statistical analyses of BE Trials PDF99KB, …)
Heads of Medicines Agencies / Human Medicines
All pages refer to current documents (PDF).
一般信息
Application for Marketing Authorisation (马)
Generics in MRP and DCP
Applicants response
Renewal Procedure
Variation Procedure
Urgent Safety Restriction

艺术. 61.3 程序
Post Referral Phase
Danish Medicines Agency (DKMA)
Guidelines and Forms en Vejledninger og skemaer da
Bioequivalence and labelling of medicinal products with regard to generic substitution: 扬 2006 (HTML36KB en, HTML42KB da)
荷兰 (GBG-MEB)
立法 & Guidelines en Wet – en regelgeving nl
Exemptions from BE-testing (positive list): for strict national registration only
(扬 2008: HTML29KB en, 十月 2007: HTML31KB nl)
美国 (FDA)
CDER Guidances
OGD Homepage
立法 (excerpts from Code of Federal Regulations, CFR)
标题 21, 卷. 1, Ch. 我, 部分 11 [21CFR11]): Electronic records; electronic signatures (Overview containing links to Subparts/Sections)
标题 21, 卷. 1, Ch. 我, 部分 50 (21CFR50): Protection of human subjects (Overview+links)
标题 21, 卷. 1, Ch. 我, 部分 56 (21CFR56): Institutional review boards (Overview+links)
标题 21, 卷. 1, Ch. 我, 部分 58 (21CFR58): GLP for Nonclinical Laboratory Studies (Overview+links)

标题 21, 卷. 5, Ch. 我, 部分 312 (21CFR312): Investigational NDA(Overview+links)
标题 21, 卷. 5, Ch. 我, 部分 320 (21CFR320): BA and BE Requirements (Overview+links)
CDER’s Manual of Policies and Procedures
Inspections of Clinical Facilities and Analytical Laboratories ConductingBE Studies Submitted in ANDAs: 十二月 2000 (PDF19KB)
Review of BE Study Protocols: 七月 2006 (PDF26KB)
Review of BE Studies with Clinical Endpoints in ANDAs: 十二月 2006 (PDF25KB)
Bioavailability / 生物等效性
The ‘Orange Book’: 31th Edition, 2011 (PDF19.2MB, Cumulative supplement [published monthly], Electronic ‘Orange Book’: Current version [including online search])
Statistical Procedures for BE Studies using a Standard Two-Treatment Crossover Design: 七月 1992 (PDF1.4MB)
Statistical Approaches Establishing BE: 扬 2001 (PDF130KB)
BA/BE—General Considerations: Revision 1, Mar 2003 (PDF268KB)
Food-Effect BA / Fed BE: 十二月 2002 (PDF166KB)
ER / in vitro/in vivo Correlations: Sep 1997 (PDF170KB)
Biowaivers / BCS: 八月 2000 (PDF54KB)
BA/BE for Nasal Aerosols / Sprays for Local Action: Draft Apr 2003 (PDF519KB; Statistical Information PDF185KB)
SUPAC [IR]: 十一月 1995 (PDF60KB, 1997 Questions and Answers HTML16KB)
SUPAC [MR]: Sep 1997 (PDF215KB)
SUPAC [SS]: 可能 1997 (PDF118KB)

BE Recommendations for Specific Products: 六月 2010 (PDF80KB), Draft May 2007 (PDF45KB; Individual Product BE Recommendations by API)
Critical Path Opportunities for Generic Drugs: 可能 2007 (HTML12KB)
Handling/Retention of BA/BE Samples: 可能 2004 (PDF166KB)
ANDA Checklist for Completeness and AcceptabilityUD: Mar 2011(PDF140KB)
Model BE Data Summary Tables: 扬 2007 (PDF219KB, DOC634KB)
Submission of Summary BE Data for ANDAsUD: Final May 2011 (PDF137KB)
Miscellaneous
Size of Beads in Drug Products Labeled for Sprinklenew: Draft Jan 2011(PDF43KB)
Bioanalytical Method Validation: 可能 2001 (PDF63KB)
Reviewer Guidance—Validation of Chromatographic Methods: 十一月 1994 (PDF703KB)
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products: 可能 1998 (PDF129KB)
Pharmacokinetics in Patients with Impaired Renal Function—Study Design, 数据分析, and Impact on Dosing and Labeling: 可能 1998 (PDF128KB), Draft Mar 2010 (PDF318KB)
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products: 十一月 1998 (PDF37KB)
Pharmacokinetics in Patients with Impaired Hepatic Function: 研究设计, 数据分析, and Impact on Dosing and Labeling: 可能 2003 (PDF222KB)
Guidance for Industry Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: Revision 2, 六月 2008 (PDF133KB)
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers: 七月 2005 (PDF702KB)
Current GMP for Phase 1 Investigational Drugs: 七月 2008 (PDF132KB)
Population PK: 2月 1999 (PDF135KB)
Safety Testing of Drug Metabolites: 2月 2008 (PDF86KB)
Drug Metabolism/Interactions: 十一月 1999 (PDF44KB)
Drug Interaction Studies—Study Design, 数据分析, and Implications for Dosing and Labeling: Draft Sep 2006 (PDF253KB)
Exposure-Response Relationships—Study Design, 数据分析, and Regulatory Applications: 4月 2003 (PDF221KB)
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: 1998—2010 (HTML8KB)
Investigator Responsibilities—Protecting the Rights, 安全, and Welfare of Study Subjects: 十月 2009 (PDF163KB)
Information Sheet Guidance for Sponsors, Clinical Investigators, andIRBs; Frequently Asked Questions–Statement of Investigator (Form FDA 1572): 可能 2010 (PDF105KB)
Safety Reporting Requirements for INDs and BA/BE Studiesnew: Sep2010 (PDF688KB)
Compilation of International Human Subjects ProtectionsUD: 2011(PDF938KB)
软件验证的一般原则; Final Guidance for Industry and FDA Staff: 扬 2002 (PDF161KB, HTML39KB)
部分 11, Electronic Records; Electronic Signatures — Scope and Application: 八月 2003 (PDF215KB)

临床研究中使用的计算机系统: 可能 2007 (PDF53KB)
If you experience problems with missing fonts in PDF-documents, have a look at this postin the forum.
ORA Bioresearch Monitoring Information Page
GLP(Non-Clinical Laboratories)
Compliance Program Guidance Manual: 2月 2001 (PDF117KB, HTML7KB)
Final Rule: 十二月 1978 (PDF6.4MB)
Proposed Rule: 十月 1984 (PDF1.7MB, HTML20KB)
Final Rule: Sep 1987 (PDF3.0MB, HTML34KB)
Questions and Answers: 六月 1981, 十二月 1999, 七月 2007 (PDF52KB,HTML22KB)
Remark: In the USA two sets of GLP regulations are in force; the other one is issued by the Environmental Protection Agency (EPA).
For a comparison between FDA’s, EPA’s, and OECD’s GLPs see the comparison charts (HTML3KB, PDF1.79MB).
赞助商, Contract Research Organizations and Monitors: 2月 2001 (PDF80KB,HTML3KB)
Clinical Investigators: 十二月 2008 (PDF240KB, HTML3KB)
Computerized Systems Used In Clinical Trials: 4月 1999 (PDF46KB, HTML12KB); for the current version (可能 2007) see CDER’s document linked in the previous section.
Guideline for the Monitoring of Clinical Investigations: 扬 1988 (HTML9KB)
Institutional Review Boards: 十月 1994 (PDF293KB)
加拿大 (HPFB/TPD)
HPFB Guidances en, Lignes directrices fr
Conduct and Analysis of Comparative BA Studies: Draft Jan 2010 (PDF190KB,HTML198KB)
Comparative BA Standards: Formulations used for Systemic Effects: Draft Jan2010 (PDF58KB, HTML42KB)
Information and Submission Requirements for Subsequent Entry Biologics (SEBs): Draft Mar 2010 (PDF96KB, HTML71KB)
BA / BE – Part A [IR]: 1992 (PDF151KB, HTML126KB)
BA / BE – Part B [MR]: 十一月 1996 (PDF594KB, HTML396KB)
BA / BE – c [IR, complicated or highly variable PK]: 十二月 1992 (PDF40KB,HTML52KB)
Inclusion of Women in Clinical Trials: 4月 1997 (PDF24KB, HTML29KB)
Drug Interactions: Sep 2000 (PDF69KB, HTML93KB)
CTAs for Comparative BA Studies: Draft Oct 2001; updated Feb 2008 (PDF241KB, HTML87KB)
Records Related to Clinical Trials: 可能 2006 (PDF137KB, HTML75KB)
Draft Policy: BE Requirements: Drugs Exhibiting Non-linear Pharmacokinetics, 六月 2003 (HTML13KB)
BE of HVDs/HVDPs: Discussion Paper, 六月 2003 (PDF61KB, HTML42KB)
Removal of Requirement for 15% Random Replicate Samples: Notice, Sep 2003 (PDF13KB, HTML21KB)
BE of Combination Drug Products: Notice, 六月 2004 (PDF12KB, HTML22KB)
Metabolites in Comparative BA Studies: Draft May 2004 (PDF27KB, HTML29KB)
Preparation of Comparative BA Information for Drug Submissions in the CTDFormat: Draft May 2004 (PDF91KB, HTML106KB)
BE in Fed State: 六月 2005 (PDF25KB, HTML30KB)
BE for Long Half-life Drugs: Notice, 六月 2005 (PDF13KB, HTML21KB)
BE for Rapid Onset Drugs: Notice, 六月 2005 (PDF15KB, HTML22KB)
BE for Critical Dose Drugs: 可能 2006 (PDF45KB, HTML42KB)
Critical Dose Drugs are: 环孢菌素, digoxin, flecainide, lithium, phenytoin, sirolimus, 克莫司, theophylline, and warfarin.
日本 (NIHS)
Division of Drugs Guidances en ???????????? ja
Clinical Pharmacokinetic Studies of Pharmaceuticals: 六月 2001 (PDF502KB)
Bioequivalence of Generic Drugs: 十二月 1997 (PDF60KB, HTML109KB)
BE for Different Strenghts: 2月 2000 (PDF33KB, HTML19KB)
Formulation Changes: 2月 2000 (PDF34KB)
Topicals: 七月 2003 (PDF68KB)
Oral Prolonged Release Dosage Forms: Mar 1988 (PDF53KB)
Following guidelines were revised with 24 十一月 2006:
BE Studies for Generic Products: (Guideline PDF175KB, PDF480KB ja;Q&A Document PDF407KB ja)
Guideline for BE Test on Oral Solid Preparation with Different Drug Strengths: (Guideline PDF78KB, PDF235KB ja; Q&A Document PDF471KB ja)
Guideline for BE Test on Oral Solid Preparation for which the Formulation has been changed: (Guideline PDF107KB, PDF251KB ja; Q&A DocumentPDF471KB ja)
Remark: The Q&A document seems to cover both topics.
Guideline for BE Studies of Generic Products for Topical Use: (Guidelineja, Q&A ja)
Guideline for BE Studies of Adding Dosage Form for Topical Use: new 24 十一月 2006 (Guideline236KB ja, Q&A43KB ja)
南非 (MCC)
指南
MCC is redesigning their website. Links to documents marked with an asterisk* are broken as of Jul 8, 2011.
Quote: We are aware of broken document links caused by a programming error and we are working with the developers to have it corrected in the shortest possible time.
Thank you for your patience.
Generic Substitution*: Final, 十二月 2003 (ZIP/DOC28KB)
Pharmaceutical and Analytical Guideline*: 七月 2007 (ZIP/DOC76KB)
Biostudies: 七月 2007 (ZIP/DOC66KB)
Dissolution: 七月 2007, except section 4.1 (七月 2008, ZIP/DOC47KB)
澳大利亚 (TGA)
指南
BA and BE: 4月 2002 (PDF212KB)
Summary of a BA or BE Study: 十二月 2002 (PDF107KB)
Australian Regulatory Guidelines for Prescription Medicines, Appendix 15: Biopharmaceutic Studies: 六月 2004 (PDF178KB)
Clinical Guidelines of the European Union adopted in Australia: 当前的 (HTML)
新西兰 (Medsafe)
指南
Guidance notes for applicants for consent to distribute new and changed medicines and related products (including BA/BE): Final, 十月 2001 (DOC5.0MB)
Biostudy Reference Products: 七月 2006 (HTML5KB)
印度 (CDSCO)
Central Drugs Standard Control Organization
Bioavailability / 生物等效性: Current Draft Mar 2005 (PDF106KB), Draft Mar 2003 (HTML0.99MB)
Requirements and Guidelines for Permission to Import and / or Manufacture of New Drugs for Sale or to Undertake Clinical Trials: Schedule Y – Amended Version, 六月 2005 (PDF8.7MB, HTML681KB)
Documents to be submitted for grant of permission to conduct Bioequivalence studies for export purpose: 八月 2009 (DOC92KB)
GCP: 2005 (HTML834KB)
Submission of Clinical Trial Application for Evaluating Safety and Efficacy: v1.1 Dec 2008 (PDF704KB)

CRO registration: Draft Jan 2011 (PDF565KB)
Amended Checklist for Test Licence Applications effective from 15 六月 2011(PDF69KB)
Clarification & Amendments in guidance for industry with respect to Post Approval Changes in Biologicals Products: 八月 2010 (PDF147KB)
Ethical Guidelines for Biomedical Research on Human Participants (published by the Indian Council of Medical Research): 十月 2006 (PDF3.1MB)
Bangladesh (DGDA)

 

Directorate General of Drug Administration
Guidance for Industry (Submission of Clinical Trial Application for Evaluating Safety and Efficacy, Requirements for permission of New Drugs Approval, Post approval changes in biological products: Quality safety and Efficacy Documents, Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological/Biological Products): 2010 (PDF555KB)

PAHO
Pan American Health Organization

Working Group on Bioequivalence
良好的临床实践 – Document of the Americas: 2005 (PDF306KB)
Science Based Criteria for BE in vivo and in vitro, Bio-Waivers and Strategic Framework for Implementation: Draft >2001? (PDF971KB)
BA / BE / Biowaivers: Final Draft Aug 2004 (PDF868KB)
巴西 (ANVISA)
Legislation en Legisla??o pt

笔记: ANVISA is redesigning their website starting in mid-August 2010. Most links are broken with no automatic redirects as of 12 九月 2008. We are trying to update links as soon as possible.
Implementation of Relative BA and BE Studies: 4月 2006 (HTML42KB pt, 十一月 2004 HTML41KB pt, 可能 2003 HTML31KB pt)
Pharmaceutical Equivalence / Dissolution: Sep 2004 (HTML33KB pt, May 2003HTML46KB pt, 可能 2003 HTML27KB pt, Mar 2002 HTML29KB pt)
BA / BE: 可能 2003 (HTML46KB en, HTML31KB pt)
Exemption and Substitution of BE Studies: 可能 2003 (HTML31KB en,HTML15KB pt, Mar 2002 HTML23KB pt)

Bioanalytical Method Validation: 可能 2003 (PDF56KB en, HTML104KB pt, Mar 2002 HTML46KB pt)
Explanation of the Implementation of Re No. 899/2003 – Validation of Bioanalytical Methods: 六月 2008 (PDF34KB pt)
National Registry of Volunteers in BE Studies: 六月 2008 (HTML26KB pt)
Statistics for BA/BE Studies: 可能 2003 (PDF48KB en, HTML49KB pt, Mar 2002HTML24KB pt)
Protocol of BE Studies: 可能 2003 (HTML32KB en, HTML16KB pt, Mar 2002HTML28KB pt)
Report of BE Studies: 可能 2003 (HTML63KB en, HTML55KB pt)
List of Reference Products: 当前的 (PDF265KB pt)
Rules / Technical Regulations for CROs: 可能 2003 (HTML720KB en,HTML586KBpt)
Annex I: Certification for BA/BE Centers: (Application Form DOC395KB,DOC148KB; Renewal Form DOC370KB, RTF365KB)
Annex II: Guidelines for Inspection at Centers of BA/BE of Medicines (DOC pt)
Annex III: Certificate of Good Practices of BA/BE of Medicines (GIF1KB pt)
Annex IV: Form for Outsourcing of Phase for Assays of BA/BE of Medicines (DOC pt)
Annex V: Form for Monthly Report of Assays of BA/BE of Medicines (DOC pt)
Remarks: The Renewal Form is not linked in Annex I, Annex II is given below ‘CLASSIFICATION OF ITEMS OF THE INSPECTION GUIDELINES’; links to Annexes II, iv, and V are broken in the English version as of 31 可能 2008.
Annexes I, III–V are given as screenshots (JPEG-format); Annex II is given below‘CLASSIFICA??O DOS ITENS DO ROTEIRO DE INSPE??O’ in the Portuguese version.
Guidance for Pharmaceutical Equivalence and Bioequivalence of Nasal Sprays and Aerosols: 六月 2008 (PDF110KB pt, PDF132KB en)
Remark: The document in English is an unofficial translation.
BA BE Good Practices Manual en
Manual de Boas Pr?ticas em Biodisponibilidade e Bioequivalencia pt
体积 1 (诊所, analytics, statistics): 2002 (ZIP/PDF6.1MB en,ZIP/PDF4.3MB pt)
体积 2 (micropipets, water for analysis, instrumentation): 2002 (ZIP/PDF6.2MB en, ZIP/PDF4.7MB pt)
墨西哥
Secretar?a de Salud es
BA / BE: Final, 可能 1999 (PDF100KB es)
BA / BE Update, Biowaivers: Mar 2000 (HTML4KB es)
Comisi?n Permanente de la Farmacopea de los Estados Unidos Mexicanos:Legislaci?n santitaria relacionada con la industria farmac?utica es
Argentin

ANMAT es

GCP Guideline for studies in human subjects: 十一月 2007 (PDF201KB es)
GCP in Clinical Studies: 1997, amended 2005 (PDF143KB es)
Good Practices in Clinical Pharmacology Research: 十一月 2010 (PDF1.0MB es)
BA / BE: Final Sep 2006, amended Mar 2007 (PDF1.8MB es, 1999 PDF389KB es)
BCS based Biowaivers for oral solid IR dosage forms: 2月 2009 (PDF97KB es)
Post approval changes: 2月 2009 (PDF154KB es)
Bioanalytical Method Validation: Sep 2005 (PDF130KB es)
Saudia Arabia
Saudi Food & Drug Authority en ??????? ?????? ?????? ?????? ar

BE: Draft May 2005 (PDF297KB)
Clinical Trials Requirements Guideline: Draft Oct 2009 (PDF374KB), Draft May 2005 (PDF318KB)
GLP: Draft Feb 2006? (PDF269KB)
Guidelines for IND requirements: Draft Aug 2009 (PDF318KB)
Guideline on Pharmaceutical Equivalence Requirements: Draft Aug 2009(PDF139KB)
Drug Master File Requirements for the Registration of Biosimilars: Draft Aug 2008 (PDF105KB)
Guidelines on Biosimilars: Draft Oct 2009 (PDF971KB)
约旦
Jordan Food and Drug Administration en ??????? ?????? ?????? ??????? ar
Law of clinical studies: 2003 (DOC55KB ar), 2001 (DOC59KB en)
埃及
Egyptian Drug Authority
BE Studies Guidelines: 扬 2010 (PDF1.0MB)
BE Requirements: Mar 2009 (DOC111KB ar)
BE Report: 十月 2008 (DOC132KB)
GLP Checklist: Draft Mar 2006 (DOC754KB)
ASEAN States (ACCSQ)
Pharmaceutical Product Working Group
BA / BE: Final Draft Jul 2004 (PDF82KB)
BE Studies Reporting Format: 2月 2008 (PDF37KB)
BE, Q&一个: 版本 2, 可能 2009 (PDF67KB); 版本 1, 七月 2008 (PDF16KB)
马来西亚 (BPFK
指南
Conduct of BA and BE Studies: Final, Sep 2000 (PDF89KB, DOC191KB)
GCP: Second Edition, 扬 2004 (PDF646KB)
GLP: Draft Jul 2006 (PDF1.7MB)

GLP: 六月 2009 (OECD’s adopted; see PDF368KB)
Guidance Document and Guidelines for Registration of Biosimilars: 八月 2008 (PDF166KB)
泰国 (FDA)
DCD
BA / BE: Mar 2009 (PDF224KB)
BA / BE: 当前的? (HTML146KB th)
BA / BE: 八月 2004(?), adopted 2005 (DOC171KB)
Instruction for the In Vivo BE Study Protocol Development: 十月 2006 (PDF1.4MB th)
BE Study Protocol / Report: 2003 (PDF52KB th)
新加坡 (HSA)
HSA
Drug Registration Information and Guidelines
Guidance on Medicinal Product Registration in Singapore: 2月 2007 (complete document PDF3.7MB)
Product Interchangeability and Biowaiver Request for chemical Generic Drug Applications: 2月 2007 (Appendix 15 PDF47KB)
ASEAN Common Technical Requirements (ACTR)
BA / BE: Final Draft Jul 2004 (PDF127KB)
Validation of Analytical Procedures: Final(?), 扬 2005 (PDF123KB)
(South) 韩国
KFDA
Guidance Document for BE Study: 十二月 2008 (PDF604KB)
Minimum Requirements for BE Test: 十二月 2005 (PDF493KB)
台湾
CDE ??????????? zh
法规 ?????????zh
BA / BE: 十二月 2006 (PDF171KB zh, HTML47KB zh)
GCP: 扬 2005 (PDF248KB zh, HTML230KB zh)
Pediatric PK: 七月 2002 (PDF195KB zh, HTML158KB zh)

Ethnic Factors in the Acceptability of Foreign Clinical Data: 可能 2002 (PDF323KB zh)
GLP: Mar 2006 (PDF200KB zh, HTML197KB zh)
Nonclinical Pharmacology/Toxicology: 六月 2000 (PDF1.0MB zh,HTML1.9MB zh)
Warning: The HTML-document was produced by means of M$ Word 11 (Office 2003), presents no valid HTML, and contains 2000+ 错误! Standard-conform browsers like Firefox <v3 were reported to crash opening this file, while M$ IE is able to render the gibberish.
Analytical Method Validation: 扬 2000 (PDF223KB zh, HTML172KB zh)
中国
SFDA en ??????????? zh
Center for Drug Evaluation ?????? zh
Drug Administration Law: 十二月 2001 (HTML64KB)
Regulations for Implementation of the Drug Administration Law: Sep 2002 (HTML63KB)
良好的临床实践: 八月 2003 (HTML46KB zh)
Statistical Guidelines for Clinical Trials of Drugs and Biologics: Mar 2005 (PDF324KB zh)
药代动力学: 2005 (PDF300KB zh)
生物等效性: 2005 (PDF328KB zh)
香港; GCP for Proprietary Chinese Medicines: 2月 2004 (PDF242KB en,PDF669KB zh)
瑞士
Swissmedic en
Instructions for Generics: 十二月 2002 (PDF704KB de/fr)
Reference Formulations for BE / CTDs for Generics: 4月 2004 (PDF659KB de/fr)
Biosimilars: 2月 2008 (PDF64KB de)
Federal Office of Public Health – AGIT
Guidelines on computerized systems

Guidelines for the archiving of Electronic Raw Data in a GLP Environment: 可能 2003 (PDF124KB)
Guidelines for the management of electronic SOPs in GLP: Sep 2006 (PDF134KB)
Guidelines for the acquisition and processing of electronic raw data in a GLPenvironment: Sep 2006 (PDF166KB)
Guidelines for the validation of computerised Systems in GLP Environment: 十二月 2007 (PDF344KB)
火鸡
Ministry of Health en MoH tr
Good Laboratory Practice Principles: 六月 2002 (HTML55KB tr)
Licensing Regulation for Pharmaceutical Products: 2003 (PDF147KB)
Submission of BA/BE Dossiers: 扬 2006 ( PDF287KB)
Remark: The document is an unofficial translation I received at my workshop in Istanbul in March 2006; I have no idea whether anything has changed in the meantime.
以色列
Ministry of Health en ???? ??????? he
Drug Registration Section he
Guidelines for Clinical Trials in Human Subjects: 扬 2006 (PDF888KB he,PDF204KB en)
SOP for Performing BE in Human Subjects: Sep 2002 (DOC132KB he)
Requirments for Registration of a Generic Product: Sep 2002 (DOC167KB he)
乌干达
National Drug Authority
Drug Registration
Guidelines on the Registration of Pharmaceuticals for Human use: 七月 2006 (PDF154KB)
Variations: 十月 2009 (PDF1.5MB)
OECD
Environment Directorate
OECD Environmental Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring

OECD Principles of Good Laboratory Practice: 4月 1999 (PDFs en, fr, en/fr,de).
Revised Guides For Compliance Monitoring Procedures for Good Laboratory Practice: 六月 1995 (PDFs en, fr, en/fr).
Revised Guidance for the Conduct of Laboratory Inspections and Study Audits: 六月 1995 (PDFs en, fr, en/fr).

Quality Assurance and GLP: 十二月 1999 (PDFs en, fr, de, es).
Compliance of Laboratory Suppliers with GLP Principles: Sep 2000 (PDFs en,fr, de, es).
The Application of the GLP Principles to Field Studies: Sep 2000 (PDFs en, fr,de, es) – not applicable for PK/BA/BE/PK, just for completeness.
The Application of the GLP Principles to Short Term Studies: 十二月 1999 (PDFsen, fr, de, es).
The Role and Responsibility of the Study Director in GLP Studies: 十月 1999 (PDFs en, fr, de).
Guidance for the Preparation of GLP Inspection Reports: 十月 1999 (PDFs en,fr, en/fr).
The Application of the Principles of GLP to Computerised Systems: 十月 1995 (PDFs en, fr, de, es: 4th link, also denoted as German).
The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP: Mar 1998 (PDFs en, fr).
Requesting and Carrying Out Inspections and Study Audits in Another Country: Sep 2000 (PDFs en, fr).
The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies: 六月 2002 (PDFs en, fr, de).
The Application of the Principles of GLP to in vitro Studies: 十一月 2004 (PDFsen, fr).
Establishment and Control of Archives that Operate in Compliance with the Principles of GLP: 六月 2007 (PDFs en, fr).
Remark: For a comparison between OECD’s, US-FDA’s, and US-EPA’s GLPs see the comparison charts (HTML, 1.8MB PDF).
PIC/S
Guides Recommendations

Good Practices for Computerized Systems in Regulated “GXP” Environments: 版本 3, Sep 2007 (PDF443KB)
EDQM

Quality Assurance Activities Guidelines
Validation of Analytical Procedures: 六月 2005 (PDF605KB)
Uncertainty of Measurements
第一部分 (compliance testing): 十二月 2007 (PDF703KB)
第二部分 (other than compliance testing): 十二月 2007 (PDF1.0MB)
Qualification of Equipment (core document): Sep 2008 (PDF1.0MB)
附件 1: Qualification of HPLC Equipment: 2月 2007 (PDF1.4MB)
附件 2: Qualification of GC Equipment: 十月 2006 (PDF897KB)
Abbreviations

ACCSQ Consultative Committee for Standards and Quality (? ASEAN)
AGIT Arbeitsgruppe Informationstechnologie (Working Group on Information Technology, 瑞士)
ANDA Abbreviated New Drug Application (? FDA)
ANMAT Administraci?n Nacional de Medicamentos, Alimentos y Tecnolog?a M?dica (National Administration for Medicines, Food and Medical Technology, 阿根廷)
ANVISA Ag?ncia Nacional de Vigil?ncia Sanit?ria (National Agency for Sanitary Monitoring, 巴西)
API Active Pharmaceutical Ingredient
ASEAN Association of Southeast Asian Nations
BA Bioavailability
BCS Biopharmaceutics Classification System
BE Bioequivalence
BPFK Biro Pengawalan Farmaseutikal Kebangsaan (National Pharmaceutical Control Bureau, 马来西亚)
CDE Center For Drug Evaluation (台湾)
CDER Center for Drug Evaluation and Research (的 ? FDA)
CDSCO Central Drugs Standard Control Organization (印度)
CHMP Committee for Medicinal Products for Human Use (的 ? EMA)
CRO Contract Research Organization
CTA Clinical Trial Application
CTD Common Technical Document (according to ? 我)
DCD Drug Control Division (泰国)
DCP Decentralised Procedure (in the ? 欧盟)
DGDA Directorate General of Drug Administration (Bangladesh)
DOC Micro$oft’s Word Format
DKMA Danish Medicines Agency
E Efficacy (Topic of ? 我)
eCTD Electronic Common Technical Document (? CTD)
EDA Egyptian Drug Authority
EDQM European Directorate for the Quality of Medicines & HealthCare
EMA European Medicines Agency (formerly European Medicines Evaluation Agency – EMEA)
ER Extended Release

EU European Union
EWP Efficacy Working Party (的 ? EMA)
FDA Food and Drug Administration (美国)
FIM First-In-Man (Clinical Study)
GCP良好的临床实践(s)
GLP Good Laboratory Practice(s)
GIF Graphics Interchange Format
GMP Good Manufacturing Practice(s)
HPFB Health Products and Food Branch (of Health Canada)
HSA Health Sciences Authority (新加坡)
HVD Highly Variable Drug
HVDP Highly Variable Drug Product
ICH International Conference on Harmonisation (of Technical Requirements for the Registration of Pharmaceuticals for Human Use)
IMP Investigational Medicinal Product
IND Investigational New Drug
IR Immediate Release
IRB Institutional Review Board
JPEG Joint Photographic Experts Group (graphics format)
JFDA Jordan Food and Drug Administration
KB Kilobyte = 1024 Bytes (filesize)
KFDA (South) Korea Food & Drug Administration
MA Marketing Authorisation (in the ? 欧盟)
MB Megabyte = 1024KB = 1048576 Bytes (filesize)
MCC Medicines Control Council (南非)
MoH Ministry of Health
MR Modified Release
MRP Mutual Recognition Procedure (in the ? 欧盟)
NDA National Drug Authority (乌干达)
NfG Note for Guidance (的 ? EMA)
NIHS National Institute for Health Sciences (日本)
NIMP Non Investigational Medicinal Product
OECD Organisation for Economic Co-operation and Development
OGD Office of Generic Drugs (的 ? FDA)
PAHO Pan American Health Organization
PDF Adobe’s Portable Document Format
PIC/S Pharmaceutical Inspection Co-operation Scheme
PK Pharmacokinetics
Q Quality (Topic of ? 我)
Q&A Questions and Answers
RTF Rich Text Format
SFDA Saudi Food & Drug Authority (Saudia Arabia)
SFDA State Food & Drug Administration (中国)
SS Semisolid
SUPAC Scale-Up and Post-Approval Changes (according to ? FDA)
TGA Therapeutic Goods Administration (澳大利亚)
TIFF Tagged Image File Format
TPD Therapeutic Products Directorate (的 ? HPFB)
WHO World Health Organization
ZIP Compressed file (format)