Guidance Documents:

• Annex 9: Tablet Friability General Chapter (PDF - 86KB) 
• Polyacrylamide Gel Electrophoresis General Chapter (PDF - 92KB) 
• E16 Genomic Biomarkers Related to Drug Response:Context, Structure, and Format of Qualification Submissions (PDF - 135KB) 
• Q8(R2) Pharmaceutical Development (PDF - 402KB) 
• 02/13/2009 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions - Annex 6: Uniformity of Dosage Units General Chapter (PDF - 87KB) 
• 02/13/2009 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions - Annex 7; Dissolution Test General Chapter (PDF - 92KB) 
• 02/13/2009 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions - Annex 8; Sterility Test General Chapter (PDF - 169KB) 
• 01/09/2009 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter (PDF - 79KB) 
• 01/09/2009 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter (PDF - 1205KB) 
• 08/07/2008 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter (PDF - 70KB) 
• 08/07/2008 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter (PDF - 66KB) 
• 08/07/2008 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter (PDF - 65KB) 
• 08/07/2008 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 5: Disintegration Test General Chapter (PDF - 264KB) 
• 06/05/2008 Q3A Impurities in New Drug Substances 
• 02/21/2008 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions 
• 02/21/2008 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 1: Residue on Ignition/Sulphated Ash General Chapter 
• 01/10/2008 Q8(R1) Pharmaceutical Development Revision 1 
• 05/19/2006 Q8 Pharmaceutical Development 
• 07/12/2007 Q10 Pharmaceutical Quality System 
• 07/31/2006 Q3B(R2) Impurities in New Drug Products 
• 03/01/1995 Q2A Text on Validation of Analytical Procedures (PDF - 28KB) 
• 05/19/1997 Q2B Validation of Analytical Procedures: Methodology (PDF - 36KB) 
• 06/01/2006 Q9 Quality Risk Management 
• 06/29/2005 Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 
• 06/07/2004 Q1E Evaluation of Stability Data 
• 11/20/2003 Q1A(R2) Stability Testing of New Drug Substances and Products 
• 11/12/2003 Q3C - Tables and List 
• 12/24/1997 Q3C Impurities: Residual Solvents 
• 01/15/2003 Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products 
• 09/25/2001 Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (PDF - 115KB) 
• 12/29/2000 Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (PDF - 393KB) 
• 08/18/1999 Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (PDF - 60KB) 
• 09/24/1998 Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (PDF - 90KB) 
• 09/21/1998 Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products (PDF - 47KB) 
• 05/16/1997 Guidelines for the Photostability Testing of New Drug Substances and Products (PDF - 59KB) 
• 11/01/1996 Q1C Stability Testing for New Dosage Forms (PDF - 101KB) 
• 07/10/1996 Stability Testing of Biotechnological/Biological Products (PDF - 26KB) 
• 02/13/2009 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 58KB) 
• 09/17/2008 S1C(R2) Dose Selection for Carcinogenicity Studies (PDF - 134KB) 
• 03/25/2008 S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use 
• 04/12/2006 S8 Immunotoxicity Studies for Human Pharmaceuticals 
• 10/19/2005 S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals 
• 07/12/2001 S7A Safety Pharmacology Studies for Human Pharmaceuticals 
• 06/25/1999 S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) (PDF - 23KB) 
• 07/01/1997 S1B Testing for Carcinogenicity of Pharmaceuticals (PDF - 146KB) 
• 04/01/1996 S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility (PDF - 100KB) 
• 03/01/1995 S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (PDF - 48KB) 
• 03/01/1995 S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies (PDF - 17KB) 
• 09/01/1994 S5A Detection of Toxicity to Reproduction for Medicinal Products (PDF - 87KB) 
• 08/05/2008 E2F Development Safety Update Report (PDF - 119KB) 
• 04/07/2008 E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories 
• 09/28/2006 E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data - Questions and Answers 
• 10/19/2005 E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs 
• 09/30/2005 E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports 
• 03/31/2005 E2E Pharmacovigilance Planning 
• 03/09/2005 E2B(M): Data Elements for Transmission of Individual Case Safety Reports: Questions and Answers (Revision 2) 
• 04/01/2002 E2BM Data Elements for Transmission of Individual Case Safety Reports (PDF - 73KB) 
• 02/04/2004 Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs 
• 11/01/1996 E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (PDF - 36KB) 
• 07/01/1996 E3 - Structure and Content of Clinical Study Reports (PDF - 221KB) 
• 09/12/2003 E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting 
• 05/11/2001 E10 Choice of Control Group and Related Issues in Clinical Trials 
• 08/01/2000 E12A Principles for Clinical Evaluation of New Antihypertensive Drugs 
• 12/15/2000 E11 Clinical Investigation of Medicinal Products in the Pediatric Population 
• 09/16/1998 E9 Statistical Principles for Clinical Trials (PDF - 109KB) 
• 06/10/1998 E5 Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 91KB) 
• 01/15/1998 E2B Guidance on Data Elements for Transmission of Individual Case Safety Reports (PDF - 71KB) 
• 12/01/1997 E8 General Considerations for Clinical Trials (PDF - 69KB) 
• 07/01/1996 E4 Dose-Response Information to Support Drug Registration (PDF - 52KB) 
• 04/01/1996 E6 Good Clinical Practice: Consolidated Guideline (PDF - 260KB) 
• 03/01/1995 E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (PDF - 20KB) 
• 03/01/1995 E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (PDF - 51KB) 
• 08/01/1994 E7 Studies in Support of Special Populations: Geriatrics (PDF - 28KB) 
• 09/04/2008 M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 
• 10/18/2005 Granularity Document Annex to M4: Organization of the CTD 
• 09/02/2005 M5 Data Elements and Standards for Drug Dictionaries 
• 03/11/2005 M2: eCTD Specification; Questions & Answers and Change Requests 
• 04/01/2003 M2 eCTD: Electronic Common Technical Document Specification (PDF - 982KB) 
• 12/22/2004 M4 CTD - Efficacy: Questions and Answers (Revision 3) 
• 12/22/2004 M4 The CTD - General: Questions and Answers (Revision 3) 
• 06/08/2004 M4 The CTD - Quality: Questions and Answers/Location Issues 
• 02/03/2003 M4 The CTD - Safety: Questions and Answers 
• 09/05/2001 Submitting Marketing Applications According to the ICH-CTD Format - General Considerations 
• 02/10/2000 M4 Common Technical Document: Modules IIA, IIB Nonclinical; Module III, Quality; Modules IV, Nonclinical; Module V, Efficacy (PDF - 363KB) 
• 08/01/2001 M4: Organization of the CTD 
• 08/01/2001 M4E: The CTD - Efficacy 
• 08/01/2001 M4Q: The CTD - Quality 
• 08/01/2001 M4S: The CTD - Safety 
• 08/01/2001 M4E: The CTD - Safety Appendices 
• 07/01/1997 S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF - 137KB)