Quality Guidelines (Q)
1. ICH Q1A-F – Stability Testing (including Q1A: Stability Testing of New Drug Substances
and Products)
2. ICH Q2(R2) – Validation of Analytical Procedures (finalized 2023)
3. ICH Q3A/B/C – Impurities (A: in new drug substances, B: in new drug products, C:
residual solvents)
4. ICH Q4B – Pharmacopoeial Harmonisation
5. ICH Q5A-E – Quality of Biotechnological Products
6. ICH Q6A/B – Specifications (A: chemical, B: biotechnological products)
7. ICH Q7 – Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients
8. ICH Q8(R2) – Pharmaceutical Development
9. ICH Q9(R1) – Quality Risk Management (revised 2023)
10. ICH Q10 – Pharmaceutical Quality System
11. ICH Q11 – Development and Manufacture of Drug Substances
12. ICH Q12 – Lifecycle Management
Safety Guidelines (S)
1. ICH S1 – Carcinogenicity Studies
2. ICH S2 – Genotoxicity Testing
3. ICH S3 – Toxicokinetics and Pharmacokinetics
4. ICH S4 – Dose Selection for Carcinogenicity
5. ICH S5(R3) – Reproductive Toxicity
6. ICH S6 – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
7. ICH S7A/B – Pharmacology Studies (general and safety)
8. ICH S8 – Immunotoxicity
9. ICH S9 – Nonclinical Evaluation for Anticancer Pharmaceuticals
10. ICH S10 – Photosafety Evaluation
Efficacy Guidelines (E)
Focus on clinical study design, conduct, safety reporting, and statistical analysis.
1. ICH E2A-E2E – Pharmacovigilance and Safety Reporting
2. ICH E3 – Clinical Study Reports
3. ICH E4 – Dose-Response Studies
4. ICH E5 – Ethnic Factors in Clinical Trials
5. ICH E6(R2) – Good Clinical Practice (GCP)
6. ICH E7 – Clinical Trials in Geriatric Population
7. ICH E8(R1) – General Considerations for Clinical Studies (revised)
8. ICH E9 – Statistical Principles
9. ICH E10 – Control Groups in Clinical Trials
10. ICH E11 – Pediatric Population
11. ICH E12-E20 – Cover topics like biomarkers, patient-reported outcomes, adaptive
designs, etc.
Multidisciplinary Guidelines (M)
Provide general guidance across domains (Quality, Safety, Efficacy).
1. ICH M1 – MedDRA (Medical Dictionary for Regulatory Activities)
2. ICH M2 – Electronic Standards for Data Submission
3. ICH M3(R2) – Nonclinical Safety Studies for the Conduct of Human Clinical Trials
4. ICH M4 – Common Technical Document (CTD)
5. ICH M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities
6. ICH M8 – eCTD (electronic CTD)
7. ICH M9 – Biopharmaceutics Classification System-based Biowaivers
8. ICH M10 – Bioanalytical Method Validation (finalized 2022)
