ICH · Guidelines
ICH guideline catalogue
A topic catalogue of the ICH guidelines adopted by FDA, EMA, and MFDS alike, organised by the Quality (Q) and Multidisciplinary (M) series. Topics with a current published document link directly to the official PDF; topics with an MFDS Korean translation also link to that translation. Check the ICH catalogue page for each series for the latest Step and revision status.
- Q1A-Q1F Q1A(R2) Stability Testing of New Drug Substances and Products
- Q2 Q2(R2) Validation of Analytical Procedures
- Q3A-Q3E Q3C(R9) Guideline for Residual Solvents
- Q4A-Q4B Q4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in ICH Regions
- Q5A-Q5E Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
- Q6A-Q6B Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Q7 Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- Q8 Q8(R2) Pharmaceutical Development
- Q9 Q9(R1) Quality Risk Management
- Q10 Q10 Pharmaceutical Quality System
- Q11 Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
- Q12 Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
- Q13 Q13 Continuous Manufacturing of Drug Substances and Drug Products
- Q14 Q14 Analytical Procedure Development
- M1 MedDRA Terminology
- M2 Electronic Standards
- M3 M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
- M4 M4(R4) Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
- M5 Data Elements and Standards for Drug Dictionaries
- M6 Gene Therapy
- M7 M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
- M8 Electronic Common Technical Document (eCTD)
- M9 M9 Biopharmaceutics Classification System-Based Biowaivers
- M10 M10 Bioanalytical Method Validation and Study Sample Analysis
- M11 M11 Clinical electronic Structured Harmonised Protocol (CeSHarP)
- M12 M12 Drug Interaction Studies
- M13 M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
- M14 M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
- M15 M15 General Principles for Model-Informed Drug Development
- M16 Structured Product Quality Submissions
- M18 Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs
