The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Organization Overview and Authority Membership

About ICH :

The International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) is a unique harmonization organization involving regulators and the pharmaceutical industry. Harmonisation is achieved through the development of ICH Guidelines that are implemented by regulatory authorities to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.

The ICH aims to achieve greater harmonization in the interpretation and application of the developed technical guidelines for the assessment and market authorization of medicinal products for human use, thereby minimizing duplication during development and the authorization process.

SFDA’s Membership in ICH

The Saudi Food and Drug Authority (SFDA) joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as a Regulatory Member in June 2021. Following that, as the first organization in the Middle East, SFDA became a member of the ICH Management Committee in June 2024, a step that corresponds to the objectives of the Kingdom’s Vision 2030 in enhancing the Kingdom’s position at the international level and achieving leadership in all fields.

In addition, SFDA was elected as a member of the MedDRA Steering Committee in May 2025, reflecting its growing role in global pharmacovigilance and safety terminology governance.

SFDA experts also take an active part in various ICH Expert Working Groups dealing with the quality and safety of medicines, preclinical and clinical requirements, and requirements regarding the content of authorization dossiers.

Draft ICH Guidelines for comments

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

Stakeholders can provide their comments by e-mailing Drug.comments@sfda.gov.sa. For this purpose please make sure to use the ICH Template in Excel format.

List of ICH Guidelines Adopted by SFDA

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)

List of ICH Working Groups with SFDA Representatives

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