ICH: efficacy

The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

• Clinical safety
• Clinical study reports
• Dose-response studies
• Ethnic factors
• Good clinical practice
• Clinical trials
• Clinical evaluation by therapeutic category
• Clinical evaluation

Clinical safety

• ICH E1 Population exposure: the extent of population exposure to assess clinical safety
• ICH E2A Clinical safety data management: definitions and standards for expedited reporting
• ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide
• ICH E2C (R2) Periodic benefit-risk evaluation report
• ICH E2D Post-approval safety data management
• ICH E2E Pharmacovigilance planning (Pvp)
• ICH E2F Development safety update report
• ICH guideline E19 on optimisation of safety data collection - Step 2b

Clinical study report

• ICH E3 Structure and content of clinical study reports

Dose response studies

• ICH E4 Dose response information to support drug registration

Ethnic factors

• ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data
• ICH E5(R1) Ethnic factors in the acceptability of foreign clinical data - questions and answers

Good clinical practice

• ICH E6 (R2) Good clinical practice

Clinical trials

• ICH E7 Studies in support of special populations: geriatrics - questions and answers
• ICH E8 General considerations for clinical studies
• ICH E9 statistical principles for clinical trials
• ICH E10 Choice of control group in clinical trials
• ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population
• ICH guideline E17 on general principles for planning and design of multi-regional clinical trials
• ICH E18 Guideline on genomic sampling and management of genomic data

Clinical evaluation by therapeutic category

• ICH E12 Principles for clinical evaluation of new antihypertensive drugs

Clinical evaluation

• ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
• ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - questions and answers
• ICH E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories
• ICH E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions