List of ICH Guidelines

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.

Quality Guidelines

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Q1A – Q1F Stability
- Q1A(R2) Stability Testing of New Drug Substances and Products
- Q1B Stability Testing : Photostability Testing of New Drug Substances and Products
- Q1C Stability Testing for New Dosage Forms
- Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
- Q1E Evaluation of Stability Data
- Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV
- Q1/Q5C EWG Targeted Revisions of the ICH Stability Guideline Series
Q2 Analytical Validation
Q3A – Q3 E Impurities
Q4A – Q4B Pharmacopoeias
Q5A -Q5E Quality of Biotechnological Products
Q6A – Q6B Specifications
Q7 Good Manufacturing Practice
Q8 Pharmaceutical developement
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System
Q11 Development and manufacture of Drug Substances
Q12 Lifecycle Management
Q13 Continuous Manufacturing of Drug Substances and Drug Products
Q14 Analytical Procedure Development

Safety Guidelines

ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.

S1A – S1C Carcinogenicity Studies
S2 Genotoxicity Studies
S3A – S3B Toxicokinetics and Pharmacokinetics
S4 Toxicity Testing
S5 Reproductive Toxicology
S6 Biotechnological Products
S7A – S7B Pharmacology Studies
S8 Immunotoxicology Studies
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
S10 Photosafety Evaluation
S11 Nonclinical Paediatric Safety
S12 Non-clinical Biodistribution Considerations for Gene Therapy Products

Efficacy Guidelines

The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.

E1 Clinical Safety for Drugs used in Long-Term Treatment
E2A – E2F Pharmacovigilance
E3 Clinical Study Reports
E4 Dose-Response Studies
E5 Ethnic Factors
E6 Good Clinical Practice
E7 Clinical Trials in Geriatic Population
E8 General Considerations for Clinical Trials
E9 Statistical Principles for Clinical Trials
E10 Choice of Control Group in Clinical Trials
E11 E11A Clinical Trials in Pediatric Population
E12 Clinical Evaluation by Therapeutic Category
E13Clinical Evaluation of QT
E15 Definitions in Pharmacogenetics / Pharmacogenomics
E16 Qualification of Genomic Biomarkers
E17 Multi-Regional Clinical Trials
E18 Genomic Sampling
E19 Safety Data Collection
E20 Adaptive Clinical Trials
E21 Inclusion of Pregnant and Breastfeeding Individuals in Clinical

Multidisciplinary Guidelines

Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI)