Deadline

Status for Consultation

Draft ICH Guidelines

13 July 2025

Closed

M13B

BIOEQUIVALENCE FOR IMMEDIATERELEASE SOLID ORAL DOSAGE FORMS

29 August 2025

Closed

Q1

Stability Testing of Drug Substances and Drug Products

15 September 2025

Closed

E21

Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

15 October 2025

Open

M4Q (R2)

The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

30 November 2025

Open

E20

Adaptive Designs for Clinical Trials

15 December 2025

Open

Q3E

Guideline on Extractables and Leachables

Adoption Date

Document title

ICH Guidelines Topic Code

August 2023

THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY FOR DRUGS INTENDED FOR LONG-TERM TREATMENT OF NON-LIFE-THREATENING CONDITIONS

Efficacy

(E1)

September 2015

CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

E2A

September 2015

PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER)

E2C(R2)

September 2015

POST-APPROVAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

E2D

September 2015

PHARMACOVIGILANCE PLANNING

E2E

July 2015

STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS

E3

August 2023

DOSE-RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION

E4

August 2023

ETHNIC FACTORS IN THE ACCEPTABILITY OF FOREIGN CLINICAL DATA

E5(R1)

August 2023

STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS

E7

August 2023

GENERAL CONSIDERATIONS FOR CLINICAL STUDIES

E8(R1)

August 2023

STATISTICAL PRINCIPLES FOR CLINICAL TRIALS

E9

August 2023

ADDENDUM ON ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS TO THE GUIDELINE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS

E9(R1)

August 2023

CHOICE OF CONTROL GROUP AND RELATED ISSUES IN CLINICAL TRIALS

E10

March 2021

 CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION

E11

August 2023

GENERAL PRINCIPLES FOR PLANNING AND DESIGN OF MULTI-REGIONAL CLINICAL TRIALS

E17

August 2023

A SELECTIVE APPROACH TO SAFETY DATA COLLECTION IN SPECIFIC LATE-STAGE PRE-APPROVAL OR POST-APPROVAL CLINICAL TRIALS

E19

September 2011

VALIDATION OF ANALYTICAL PROCEDURES

Quality

 (Q2(R2))

September 2011

IMPURITIES IN NEW DRUG SUBSTANCES

Q3A(R2)

September 2011

IMPURITIES IN NEW DRUG PRODUCTS

Q3B(R2)

February 2025

IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS

Q3C(R9)

GUIDELINE FOR ELEMENTAL IMPURITIES

Q3D(R2)

September 2011

VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN

Q5A(R1)

September 2011

QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF R-DNA DERIVED PROTEIN PRODUCTS

Q5B

February 2011

QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS

Q5C

September 2011

DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS

Q5D

August 2017

COMPARABILITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS

Q5E

September 2011

SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES

Q6A

September 2011

SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS

Q6B

July 2011

GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS

Q7

July 2011

PHARMACEUTICAL DEVELOPMENT

Q8(R2)

July 2011

QUALITY RISK MANAGEMENT

Q9(R1)

July 2011

PHARMACEUTICAL QUALITY SYSTEM

Q10

July 2011

DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES)

Q11

CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS

Q13

January 2024

GUIDELINE ON NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS

Safety

(S1A)

January 2024

TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS

S1B(R1)

January 2024

DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS

S1C(R2)

January 2024

GUIDANCE ON GENOTOXICITY TESTING AND DATA INTERPRETATION FOR PHARMACEUTICALS INTENDED FOR HUMAN USE

S2(R1)

January 2024

NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES

S3A

January 2024

 GUIDANCE FOR REPEATED DOSE TISSUE DISTRIBUTION STUDIES

S3B

January 2024

DURATION OF CHRONIC TOXICITY TESTING IN ANIMALS (RODENT AND NON RODENT TOXICITY TESTING).

S4

January 2024

DETECTION OF REPRODUCTIVE AND DEVELOPMENTAL TOXICITY FOR HUMAN PHARMACEUTICALS

S5(R3)

March 2021

PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS

S6(R1)

March 2021

SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS

S7A

March 2021

THE NON-CLINICAL EVALUATION OF THE POTENTIAL FOR DELAYED VENTRICULAR REPOLARIZATION (QT INTERVAL PROLONGATION)

BY HUMAN PHARMACEUTICALS

S7B

January 2024

IMMUNOTOXICITY STUDIES

 FOR HUMAN PHARMACEUTICALS

S8

March 2021

NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS

S9

January 2024

NONCLINICAL SAFETY TESTING IN SUPPORT OF DEVELOPMENT OF PAEDIATRIC MEDICINES

S11

January 2024

NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS

S12

March 2021

 GUIDANCE ON NONCLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS AND MARKETING AUTHORIZATION FOR PHARMACEUTICALS

Multidisciplinary

M3(R2)

September 2011

ORGANISATION INCLUDING THE GRANULARITY DOCUMENT THAT PROVIDES GUIDANCE ON DOCUMENT LOCATION AND PAGINATIONS

M4(R4)

September 2011

CTD on Efficacy

M4E(R2)

September 2011

CTD on Safety

M4S(R2)

September 2011

CTD on Quality

M4Q(R1)

ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK

M7(R2)

Status

Guidelines Topic Code

Working group

-

M18 EWG

Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar

-

E23 EWG

Considerations for the use of Real-World Evidence (RWE) to inform regulatory decision making with a focus on effectiveness of medicine

-

-

Cell and Gene Therapies Discussion Group (CGTDG)

-

Q6(R1) EWG

Revision of the Specifications Guidelines

Step 5

E11A EWG

Pediatric Extrapolation

Step 3

E20 EWG

 Adaptive Designs for Clinical Trials

Step 3

E21 EWG

Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

Step 1

E22 EWG

General Considerations for Patient Preference Studies

-

E2B(R3) EWG/IWG

Electronic Transmission of Individual Case Safety Reports

Step 3

M11 EWG

Clinical electronic Structured Harmonized Protocol (CeSHarP)

Step 3

M14 EWG

General Principles on Plan, Design, Analysis and Reporting of Non-Interventional Studies that Utilize Real-World Data for Safety Assessment of Medicines

Step 3

M15 EWG

General principles for Model-Informed Drug Development

Step 3

M4Q(R2) EWG

Revision of M4Q(R1) CTD on Quality Guidance

Step 3

Q1 EWG

Stability Testing of Drug Substances and Drug Products

-

Q2(R2)/Q14 IWG

Training on Validation of Analytical Procedure and Q14: Analytical Procedure Development

-

Q5A(R2)

Training on viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Step 1

M7 Sub-Group

Risk Assessment and Control of Nitrosamine Impurities

-

S13 EWG

Nonclinical Safety Studies for Oligonucleotide-Based Therapeutics