International Conference on Harmonisation


Development Safety Update Report; E2F: step 4, Aug 2010 (PDF334KB)
Structure and Content of Clinical Study Reports; E3: Nov 1995 (PDF471KB)
Good Clinical Practice; E6(R1): step 4, Jun 1996 (PDF380KB; including IBtemplate)
General Considerations for Clinical Trials; E8: Jul 1997 (PDF182KB)
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; E2A: step 4, Oct 1994 (PDF145KB)
Statistical Principles for Clinical Trials; E9: Feb 1998 (PDF284KB)
Validation of Analytical Procedures – Text and Methodology; Q2(R1): step 4, Nov 2005 (PDF180KB)
Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products – Chemical Substances; Q6A: Oct 1995 (PDF211KB, Decision Trees PDF46KB)
All documents are in step 5 (implementation state) unless noted otherwise.
World Health Organization

Guidelines for GCP for trials on pharmaceutical products (WHO Technical Report Series No. 850, Annex 3): 1995 (PDF104KB)
Handbook for GCP: 2005 (PDF560KB)
Prequalification Programme
Information for Applicants: Guidelines: Generics
Main text: Guideline on Generics – Pharmaceutical Quality and BE(333KB PDF); selected annex and supplement below.
Annex 7, Presentation of BE Trial Information (BTIF): Jan 2010(DOC440KB, ZIP/DOC245KB), Aug 2005 (DOC424KB, ZIP/DOC244KB)
Supplement 1 (Dissolution testing): Jul 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, Annex 5); Fixed dose combinations: Jun 2005 (PDF974KB)
WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fortieth Report (WHO TRS No. 937): May 2006 (PDF1.9MB); Annexes 7–9 are available in separate documents:
Annex 7: Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (PDF425KB)
Annex 8: Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms (PDF464KB)
Annex 9: Additional guidance for organizations performing in vivobioequivalence studies (PDF371KB)
WHO Expert Committee on Biological Standardization; Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs): Oct 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)
European Union (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: Jan 2009 (PDF102KB)
Guidelines: Clinical Efficacy and Safety HTML, Multidisciplinary HTML
Directive 2001/20/EC (Implementation of GCP in the Conduct of Clinical Trials on Medicinal Products for Human Use): Apr 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): Oct 2003 (PDF115KB)
Directive 2004/9/EC (Inspection and Verification of GLP): Feb 2004 (in many European languages and formats [HTML, PDF, TIFF], e.g., 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): Feb 2004 (in many European languages and formats [HTML, PDF, TIFF], e.g., 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): Apr 2005 (PDF66KB)
Requirements to the Chemical and Pharmaceutical Quality Documentation concerning IMPs in Clinical Trials: Mar 2006 (PDF141KB)
Definition of IMPs and NIMPs: Jul 2006 (PDF51KB)
Additional Information on IMPs: Apr 2007 (PDF41KB)
GMP, Medicinal Products for Human and Veterinary Use, Annex 13, IMPs: Jan 2010 (PDF66B)
Bioavailability / Bioequivalence
Note for Guidance and associated documents
Bioequivalence: Jan 2010 (PDF236KB), Overview of comments Jan2010 (PDF1.5MB) Draft Jul 2008 (PDF436KB) Recommendation on the Need for Revision of NfG on BA/BE: May 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: Apr 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)
Questions & Answers on the BA and BE Guideline: Jul 2006 (PDF118KB PDF)
Bioavailability / Bioequivalence*: Jul 2001 (PDF99KB PDF).
BA/BE for HVDs/HVDPs: Apr 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: May 2007 (PDF43KB)
Reflection paper: Advice to Applicants/Sponsors/CROs of BEStudies: Sep 2008 (PDF104KB)
Modified Release Oral / Transdermals: Jul 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): May 2010 (PDF78KB)
Concept paper on the need for revision of the note for guidance on modified release oral and transdermal dosage forms: Section I (quality): Jul 2010 (PDF95KB)
Pharmacokinetic Studies in Man: Oct 1988 (PDF39KB)
PK Studies in Patients with Renal Impairment: Jun 2004 (PDF213KB)
Evaluation of the PK of Medicinal Products in Patients with Impaired Hepatic Function: Feb 2005 (PDF92KB)
PK in the Development of Medicinal Products in the Paediatric Population: Jun 2006 (PDF115KB)
Reflection paper: Use of Pharmacogenetics in the PK Evaluation of Medicinal Products: May 2007 (PDF61KB)
Concept Paper on the Development of a Guideline on the Use of Pharmacogenomic Methodologies in the PK Evaluation of Medicinal Products: Apr 2009 (PDF53KB)
Reporting Results of Population PK Analyses: Jun 2007 (PDF68KB)
Strategies to Identify and Mitigate Risks for First-In Human Clinical Trials with IMPs: Jul 2007 (PDF83KB)
Statistical Issues
Biostatistical Methodology in Clinical Trials*: Oct 1993 (PDF153KB PDF).
Points to Consider on Multiplicity Issues in Clinical Trials: Sep 2002 (PDF208KB)
Guideline on missing data in confirmatory clinical trials: Jul 2010(PDF142KB) Draft Apr 2009 (PDF99KB) Recommendation for the Revision of the Points to Consider on Missing Data (CPMP/EWP/1776/99): Dec 2007 (PDF35KB) Points to Consider on Missing Data: Nov 2001 (PDF38KB)
Biotechnological and Biological Products, Biosimilars
Development Pharmaceutics for Biotechnological and Biological Products – Annex to Note for Guidance on Development Pharmaceutics: Oct 1999 (PDF36KB)
Clinical Investigation of the PK of Therapeutic Proteins: Jan 2007 (PDF98KB, Draft Jul 2005 (PDF101KB)
Similar Biological Medicinal Product: Oct 2005 (PDF106KB)
Q&A on biosimilar medicines: Oct 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: Feb 2006 (PDF102KB)
Comparability of Biotechnology-Derived Medicinal Products after a change in the Manufacturing Process – Non-Clinical and Clinical Issues: Jul 2007 (PDF118KB) Draft Jan 2007 (PDF171KB) Concept paper Feb 2006 (PDF38KB) Final Dec 2003 (PDF194KB)
Product specific biosimilar guidelines
Recombinant Human Insulin: Feb 2006 (PDF102KB)
Somatropin: Feb 2006 (PDF78KB)
Recombinant Granulocyte-Colony Stimulating Factor: Feb 2006 (PDF89KB)
Recombinant Erythropoietins: Apr 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)
Q&A: Positions on specific questions addressed to the Pharmacokinetics Working Party (PKWP): Jan 2011 (PDF195KB) Jul 2010 ( PDF182KB) Jul2009 (PDF89KB PDF) Jun 2009 (PDF94KB PDF) Jan 2009 ( PDF87KB)
Scientific Advice & Protocol Assistance: Revision 6, May 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: Dec 2008 (PDF52KB)
Validation of Analytical Procedures. Text and Terminology: Nov 1994, Methodology: Dec 1996 (PDF186KB)
Test on Samples of Biological Origin: Jul 1989 (PDF39KB)
Clinical Investigation of Chiral Active Substances: Apr 1994 (PDF52KB)
Topicals: Nov 1995 (PDF43KB)
Fixed Combination Medicinal Products: Feb 2009 (PDF92KB)
Drug Interactions: Dec 1997 (PDF79KB)
Concept Paper/Recommendation on the Need for Revision of NfG on the Investigation of Drug Interactions: Jul 2008 (PDF31KB)
Drug Interactions: Draft Apr 2010 (PDF352KB)
Development Pharmaceutics: Jan 1998 (PDF58KB)

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

to Consider on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP): Feb 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): Jan 2009 (PDF271KB), Draft Oct 2007 (PDF176KB), Appendix 1: Mar 2008 (PDF44KB)
Gender Considerations in the Conduct of Clinical Trials: Jan 2005 (PDF75KB)
Guideline on Pharmaceutical Development of Medicines for Paediatric Usenew: Draft May 2011 (PDF247KB)Consultation 31 Dec 2011
Inspections – Good Clinical Practice: Set of 13 documents, Sep 2007 – May 2008 (e.g., Investigator Site PDF39KB, Sponsor and/or Contract Research Organisations PDF36KB, Phase I Units PDF31KB, Bioanalytical part, Pharmacokinetic and Statistical analyses of BE Trials PDF99KB, …)
Heads of Medicines Agencies / Human Medicines
All pages refer to current documents (PDF).
General Information
Application for Marketing Authorisation (MA)
Generics in MRP and DCP
Applicants response
Renewal Procedure
Variation Procedure
Urgent Safety Restriction

Art. 61.3 Procedure
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: Jan 2006 (HTML36KB en, HTML42KB da)
Netherlands (GBG-MEB)
Legislation & Guidelines en Wet – en regelgeving nl
Exemptions from BE-testing (positive list): for strict national registration only
(Jan 2008: HTML29KB en, Oct 2007: HTML31KB nl)
CDER Guidances
OGD Homepage
Legislation (excerpts from Code of Federal Regulations, CFR)
Title 21, Vol. 1, Ch. I, Part 11 [21CFR11]): Electronic records; electronic signatures (Overview containing links to Subparts/Sections)
Title 21, Vol. 1, Ch. I, Part 50 (21CFR50): Protection of human subjects (Overview+links)
Title 21, Vol. 1, Ch. I, Part 56 (21CFR56): Institutional review boards (Overview+links)
Title 21, Vol. 1, Ch. I, Part 58 (21CFR58): GLP for Nonclinical Laboratory Studies (Overview+links)

Title 21, Vol. 5, Ch. I, Part 312 (21CFR312): Investigational NDA(Overview+links)
Title 21, Vol. 5, Ch. I, Part 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: Dec 2000 (PDF19KB)
Review of BE Study Protocols: Jul 2006 (PDF26KB)
Review of BE Studies with Clinical Endpoints in ANDAs: Dec 2006 (PDF25KB)
Bioavailability / Bioequivalence
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: Jul 1992 (PDF1.4MB)
Statistical Approaches Establishing BE: Jan 2001 (PDF130KB)
BA/BE—General Considerations: Revision 1, Mar 2003 (PDF268KB)
Food-Effect BA / Fed BE: Dec 2002 (PDF166KB)
ER / in vitro/in vivo Correlations: Sep 1997 (PDF170KB)
Biowaivers / BCS: Aug 2000 (PDF54KB)
BA/BE for Nasal Aerosols / Sprays for Local Action: Draft Apr 2003 (PDF519KB; Statistical Information PDF185KB)
SUPAC [IR]: Nov 1995 (PDF60KB, 1997 Questions and Answers HTML16KB)
SUPAC [MR]: Sep 1997 (PDF215KB)
SUPAC [SS]: May 1997 (PDF118KB)

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

Computerized Systems Used in Clinical Investigations: May 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: Feb 2001 (PDF117KB, HTML7KB)
Final Rule: Dec 1978 (PDF6.4MB)
Proposed Rule: Oct 1984 (PDF1.7MB, HTML20KB)
Final Rule: Sep 1987 (PDF3.0MB, HTML34KB)
Questions and Answers: Jun 1981, Dec 1999, Jul 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).
Sponsors, Contract Research Organizations and Monitors: Feb 2001 (PDF80KB,HTML3KB)
Clinical Investigators: Dec 2008 (PDF240KB, HTML3KB)
Computerized Systems Used In Clinical Trials: Apr 1999 (PDF46KB, HTML12KB); for the current version (May 2007) see CDER’s document linked in the previous section.
Guideline for the Monitoring of Clinical Investigations: Jan 1988 (HTML9KB)
Institutional Review Boards: Oct 1994 (PDF293KB)
Canada (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]: Nov 1996 (PDF594KB, HTML396KB)
BA / BE – Part C [IR, complicated or highly variable PK]: Dec 1992 (PDF40KB,HTML52KB)
Inclusion of Women in Clinical Trials: Apr 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: May 2006 (PDF137KB, HTML75KB)
Draft Policy: BE Requirements: Drugs Exhibiting Non-linear Pharmacokinetics, Jun 2003 (HTML13KB)
BE of HVDs/HVDPs: Discussion Paper, Jun 2003 (PDF61KB, HTML42KB)
Removal of Requirement for 15% Random Replicate Samples: Notice, Sep 2003 (PDF13KB, HTML21KB)
BE of Combination Drug Products: Notice, Jun 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: Jun 2005 (PDF25KB, HTML30KB)
BE for Long Half-life Drugs: Notice, Jun 2005 (PDF13KB, HTML21KB)
BE for Rapid Onset Drugs: Notice, Jun 2005 (PDF15KB, HTML22KB)
BE for Critical Dose Drugs: May 2006 (PDF45KB, HTML42KB)
Critical Dose Drugs are: cyclosporine, digoxin, flecainide, lithium, phenytoin, sirolimus, tacrolimus, theophylline, and warfarin.
Japan (NIHS)
Division of Drugs Guidances en ???????????? ja
Clinical Pharmacokinetic Studies of Pharmaceuticals: Jun 2001 (PDF502KB)
Bioequivalence of Generic Drugs: Dec 1997 (PDF60KB, HTML109KB)
BE for Different Strenghts: Feb 2000 (PDF33KB, HTML19KB)
Formulation Changes: Feb 2000 (PDF34KB)
Topicals: Jul 2003 (PDF68KB)
Oral Prolonged Release Dosage Forms: Mar 1988 (PDF53KB)
Following guidelines were revised with 24 Nov 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 Nov 2006 (Guideline236KB ja, Q&A43KB ja)
South Africa (MCC)
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, Dec 2003 (ZIP/DOC28KB)
Pharmaceutical and Analytical Guideline*: Jul 2007 (ZIP/DOC76KB)
Biostudies: Jul 2007 (ZIP/DOC66KB)
Dissolution: Jul 2007, except section 4.1 (Jul 2008, ZIP/DOC47KB)
Australia (TGA)
BA and BE: Apr 2002 (PDF212KB)
Summary of a BA or BE Study: Dec 2002 (PDF107KB)
Australian Regulatory Guidelines for Prescription Medicines, Appendix 15: Biopharmaceutic Studies: Jun 2004 (PDF178KB)
Clinical Guidelines of the European Union adopted in Australia: current (HTML)
New Zealand (Medsafe)
Guidance notes for applicants for consent to distribute new and changed medicines and related products (including BA/BE): Final, Oct 2001 (DOC5.0MB)
Biostudy Reference Products: Jul 2006 (HTML5KB)
India (CDSCO)
Central Drugs Standard Control Organization
Bioavailability / Bioequivalence: 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, Jun 2005 (PDF8.7MB, HTML681KB)
Documents to be submitted for grant of permission to conduct Bioequivalence studies for export purpose: Aug 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 June 2011(PDF69KB)
Clarification & Amendments in guidance for industry with respect to Post Approval Changes in Biologicals Products: Aug 2010 (PDF147KB)
Ethical Guidelines for Biomedical Research on Human Participants (published by the Indian Council of Medical Research): Oct 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)

    Pan American Health Organization

    Working Group on Bioequivalence
    Good Clinical Practices – 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)
    Brazil (ANVISA)
    Legislation en Legisla??o pt

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

    Bioanalytical Method Validation: May 2003 (PDF56KB en, HTML104KB pt, Mar 2002 HTML46KB pt)
    Explanation of the Implementation of Re No. 899/2003 – Validation of Bioanalytical Methods: Jun 2008 (PDF34KB pt)
    National Registry of Volunteers in BE Studies: Jun 2008 (HTML26KB pt)
    Statistics for BA/BE Studies: May 2003 (PDF48KB en, HTML49KB pt, Mar 2002HTML24KB pt)
    Protocol of BE Studies: May 2003 (HTML32KB en, HTML16KB pt, Mar 2002HTML28KB pt)
    Report of BE Studies: May 2003 (HTML63KB en, HTML55KB pt)
    List of Reference Products: Current (PDF265KB pt)
    Rules / Technical Regulations for CROs: May 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 May 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: Jun 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
    Volume 1 (clinics, analytics, statistics): 2002 (ZIP/PDF6.1MB en,ZIP/PDF4.3MB pt)
    Volume 2 (micropipets, water for analysis, instrumentation): 2002 (ZIP/PDF6.2MB en, ZIP/PDF4.7MB pt)
    Secretar?a de Salud es
    BA / BE: Final, May 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

    ANMAT es

    GCP Guideline for studies in human subjects: Nov 2007 (PDF201KB es)
    GCP in Clinical Studies: 1997, amended 2005 (PDF143KB es)
    Good Practices in Clinical Pharmacology Research: Nov 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: Feb 2009 (PDF97KB es)
    Post approval changes: Feb 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)
    Jordan Food and Drug Administration en ??????? ?????? ?????? ??????? ar
    Law of clinical studies: 2003 (DOC55KB ar), 2001 (DOC59KB en)
    Egyptian Drug Authority
    BE Studies Guidelines: Jan 2010 (PDF1.0MB)
    BE Requirements: Mar 2009 (DOC111KB ar)
    BE Report: Oct 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: Feb 2008 (PDF37KB)
    BE, Q&A: Version 2, May 2009 (PDF67KB); Version 1, Jul 2008 (PDF16KB)
    Malaysia (BPFK
    Conduct of BA and BE Studies: Final, Sep 2000 (PDF89KB, DOC191KB)
    GCP: Second Edition, Jan 2004 (PDF646KB)
    GLP: Draft Jul 2006 (PDF1.7MB)

    GLP: Jun 2009 (OECD’s adopted; see PDF368KB)
    Guidance Document and Guidelines for Registration of Biosimilars: Aug 2008 (PDF166KB)
    Thailand (FDA)
    BA / BE: Mar 2009 (PDF224KB)
    BA / BE: Current? (HTML146KB th)
    BA / BE: Aug 2004(?), adopted 2005 (DOC171KB)
    Instruction for the In Vivo BE Study Protocol Development: Oct 2006 (PDF1.4MB th)
    BE Study Protocol / Report: 2003 (PDF52KB th)
    Singapore (HSA)
    Drug Registration Information and Guidelines
    Guidance on Medicinal Product Registration in Singapore: Feb 2007 (complete document PDF3.7MB)
    Product Interchangeability and Biowaiver Request for chemical Generic Drug Applications: Feb 2007 (Appendix 15 PDF47KB)
    ASEAN Common Technical Requirements (ACTR)
    BA / BE: Final Draft Jul 2004 (PDF127KB)
    Validation of Analytical Procedures: Final(?), Jan 2005 (PDF123KB)
    (South) Korea
    Guidance Document for BE Study: Dec 2008 (PDF604KB)
    Minimum Requirements for BE Test: Dec 2005 (PDF493KB)
    CDE ??????????? zh
    Regulations ?????????zh
    BA / BE: Dec 2006 (PDF171KB zh, HTML47KB zh)
    GCP: Jan 2005 (PDF248KB zh, HTML230KB zh)
    Pediatric PK: Jul 2002 (PDF195KB zh, HTML158KB zh)

    Ethnic Factors in the Acceptability of Foreign Clinical Data: May 2002 (PDF323KB zh)
    GLP: Mar 2006 (PDF200KB zh, HTML197KB zh)
    Nonclinical Pharmacology/Toxicology: Jun 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+ Errors! 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: Jan 2000 (PDF223KB zh, HTML172KB zh)
    SFDA en ??????????? zh
    Center for Drug Evaluation ?????? zh
    Drug Administration Law: Dec 2001 (HTML64KB)
    Regulations for Implementation of the Drug Administration Law: Sep 2002 (HTML63KB)
    Good Clinical Practice: Aug 2003 (HTML46KB zh)
    Statistical Guidelines for Clinical Trials of Drugs and Biologics: Mar 2005 (PDF324KB zh)
    Pharmacokinetics: 2005 (PDF300KB zh)
    Bioequivalence: 2005 (PDF328KB zh)
    Hong Kong; GCP for Proprietary Chinese Medicines: Feb 2004 (PDF242KB en,PDF669KB zh)
    Swissmedic en
    Instructions for Generics: Dec 2002 (PDF704KB de/fr)
    Reference Formulations for BE / CTDs for Generics: Apr 2004 (PDF659KB de/fr)
    Biosimilars: Feb 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: May 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: Dec 2007 (PDF344KB)
    Ministry of Health en MoH tr
    Good Laboratory Practice Principles: Jun 2002 (HTML55KB tr)
    Licensing Regulation for Pharmaceutical Products: 2003 (PDF147KB)
    Submission of BA/BE Dossiers: Jan 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.
    Ministry of Health en ???? ??????? he
    Drug Registration Section he
    Guidelines for Clinical Trials in Human Subjects: Jan 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)
    National Drug Authority
    Drug Registration
    Guidelines on the Registration of Pharmaceuticals for Human use: Jul 2006 (PDF154KB)
    Variations: Oct 2009 (PDF1.5MB)
    Environment Directorate
    OECD Environmental Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring

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

    Quality Assurance and GLP: Dec 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: Dec 1999 (PDFsen, fr, de, es).
    The Role and Responsibility of the Study Director in GLP Studies: Oct 1999 (PDFs en, fr, de).
    Guidance for the Preparation of GLP Inspection Reports: Oct 1999 (PDFs en,fr, en/fr).
    The Application of the Principles of GLP to Computerised Systems: Oct 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: Jun 2002 (PDFs en, fr, de).
    The Application of the Principles of GLP to in vitro Studies: Nov 2004 (PDFsen, fr).
    Establishment and Control of Archives that Operate in Compliance with the Principles of GLP: Jun 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).
    Guides Recommendations

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

    Quality Assurance Activities Guidelines
    Validation of Analytical Procedures: Jun 2005 (PDF605KB)
    Uncertainty of Measurements
    Part I (compliance testing): Dec 2007 (PDF703KB)
    Part II (other than compliance testing): Dec 2007 (PDF1.0MB)
    Qualification of Equipment (core document): Sep 2008 (PDF1.0MB)
    Annex 1: Qualification of HPLC Equipment: Feb 2007 (PDF1.4MB)
    Annex 2: Qualification of GC Equipment: Oct 2006 (PDF897KB)

    ACCSQ Consultative Committee for Standards and Quality (? ASEAN)
    AGIT Arbeitsgruppe Informationstechnologie (Working Group on Information Technology, Switzerland)
    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, Argentina)
    ANVISA Ag?ncia Nacional de Vigil?ncia Sanit?ria (National Agency for Sanitary Monitoring, Brazil)
    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, Malaysia)
    CDE Center For Drug Evaluation (Taiwan)
    CDER Center for Drug Evaluation and Research (of the ? FDA)
    CDSCO Central Drugs Standard Control Organization (India)
    CHMP Committee for Medicinal Products for Human Use (of the ? EMA)
    CRO Contract Research Organization
    CTA Clinical Trial Application
    CTD Common Technical Document (according to ? ICH)
    DCD Drug Control Division (Thailand)
    DCP Decentralised Procedure (in the ? EU)
    DGDA Directorate General of Drug Administration (Bangladesh)
    DOC Micro$oft’s Word Format
    DKMA Danish Medicines Agency
    E Efficacy (Topic of ? ICH)
    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 (of the ? EMA)
    FDA Food and Drug Administration (United States)
    FIM First-In-Man (Clinical Study)
    GCP Good Clinical Practice(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 (Singapore)
    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 ? EU)
    MB Megabyte = 1024KB = 1048576 Bytes (filesize)
    MCC Medicines Control Council (South Africa)
    MoH Ministry of Health
    MR Modified Release
    MRP Mutual Recognition Procedure (in the ? EU)
    NDA National Drug Authority (Uganda)
    NfG Note for Guidance (of the ? EMA)
    NIHS National Institute for Health Sciences (Japan)
    NIMP Non Investigational Medicinal Product
    OECD Organisation for Economic Co-operation and Development
    OGD Office of Generic Drugs (of the ? 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 ? ICH)
    Q&A Questions and Answers
    RTF Rich Text Format
    SFDA Saudi Food & Drug Authority (Saudia Arabia)
    SFDA State Food & Drug Administration (China)
    SS Semisolid
    SUPAC Scale-Up and Post-Approval Changes (according to ? FDA)
    TGA Therapeutic Goods Administration (Australia)
    TIFF Tagged Image File Format
    TPD Therapeutic Products Directorate (of ? HPFB)
    WHO World Health Organization
    ZIP Compressed file (format)

    Categories: Bioequivalence


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