The International Council for Harmonisation (ICH) is a joint initiative between regulators and the pharmaceutical industry to harmonize technical requirements for drug registration. The goal is to streamline development, eliminate redundant testing, and make new medicines available more quickly while maintaining standards of safety and efficacy. ICH involves six regulatory and industry parties working to produce unified guidelines for the European Union, Japan, and United States on quality, safety, and efficacy. This helps facilitate mutual acceptance of clinical data between jurisdictions.

1. ICH is a unique joint initiative involving both regulators and industry as equal partners in the scientific
and technical discussions of the testing procedures which are required to ensure and assess the safety,
quality and efficacy of medicines.
 The purpose is to make recommendations on ways to achieve greater harmonization in
the interpretation
 Application of technical guidelines
 Requirements for product registration in order to reduce or obviate the need to
duplicate the testing carried out during the research and development of new
medicines.
 Aim to produce a single set of technical requirements for the registration of new drug,
drug products to streamline development.
 Reduce or obviate duplicate testing
 More economical use of human, animal and material resources.
 Eliminate unnecessary delays in the availability of new medicines.
 Availability of new medicines whilst maintaining safeguards on quality, safety and
efficacy, and regulatory obligations to protect public health.
 To provide a unified standard for the European Union (EU), Japan & United States to
facilitate mutual acceptance of clinical data by the regulatory authorities in these
jurisdictions
 Members:
Steering committee (SC):
ICH Parties - 6
ICH – Coordinators (One from each party)
Observers - 3 (non-voting)
IFPMA: Secretariat
Expert Working Groups (EWGs) :The SC is advised on technical issues concerned with
harmonization topics by Expert Working Groups. They are nominated from the 6 Co –Sponsors.
 Participants
Six Parties: EU, EFPIA, FDA, MHLW, JPMA, PhRMA,
Three Observers: WHO, EFTA, Canada
 Commission - European Union (EU)

2.  European Federation of Pharmaceutical Industries and Associations (EFPIA)
 US Food and Drug Administration (FDA)
 Pharmaceutical Research and Manufacturers of America (PhRMA)
 Ministry of Health, Labor and Welfare, Japan (MHLW)
 Japan Pharmaceutical Manufacturers Association (JPMA) .
STEERING COMMITTEE:
 Oversees the preparation for ICH and the harmonization initiatives under taken
under the ICH Process.
 2 members from each of the 6 co-sponsors
 Determines policies & procedures
 Selects topics for harmonization
 Monitors progress of harmonization initiatives
 Five-step approach
 Step 1: Consensus building
 Step 2: Confirmation of six-party harmonised and consensus text released
 Step 3: Regulatory Consultation and Discussion outside the ICH
 Step 4: Adoption of an ICH Harmonized Guideline
 Step 5: Implementation
Quality (Q) - chemical & pharmaceutical QA
Q 1(A-F): Stability - Photostability
Q 2: Analytical Validation
Q 3(A-C): Impurities
Q 5(A-E): Biotechnological Quality
Q 6(A,B): Specifications
Q 7: GMP for active pharma ingredients
Q 8: Pharmaceutical development
Q 9: Quality risk management
Q10: Pharmaceutical Quality System

3. Safety (S) -dealing with in vitro & in vivo pre clinical testing
S1: Carcinogenicity studies – Need, Testing, Dose Selection
S2: Genotoxicity – Regulatory, Battery of Tests
S3A: Toxicokinetics
S3B: Pharmacokinetics
S4: Chronic Toxicity Testing
S5A: Toxicity to Reproduction
S5B: Toxicity to Male Fertility
S6: Preclinical Biotech derived drugs
S7A: Safety Pharmacology
S7B: QT interval prolongation
S8: Immunotoxicity for Human Pharmaceuticals
S9 : Nonclinical Evaluation for Anticancer Pharmaceuticals
Efficacy (E) -clinical studies in human beings
E 1: Exposure to assess clinical safety
E 2: Clinical Safety Data Management
E 3: Study Reports
E 4: Dose Response Studies
E 5: Ethnic Factors
E 6: Good Clinical Practice (GCP)
E 7: Special Populations – Geriatrics
E 8: Clinical Trials Design
E 9: Statistical Considerations
E 10: Choice of Control Group
E 11: Special Populations – Children
E 12: Therapeutic categories
E 14: The clinical evaluation of QT/QC interval prolongation & pro arrhythmic potential for non
antiarrhythmic drugs

4. E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data &
Sample Coding Categories
E16: Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification
Submissions
Multidisciplinary (M) -deals with Terminology, Electronic Standards, Common Documents.
M1: Medical Terminology
M2: Electronic Standards for Transfer of Regulatory Information & Data (ESTRI)
M3: Maintenance of ICH guidelines for nonclinical safety studies
M4: Common Technical Document (CTD)
M5: Data Elements and Standards for Drug Dictionaries
FDA Center for Drug Evaluation and Research (CDER)
The mission of FDA's Center for Drug Evaluation and Research is to assure that safe and
effective drugs are available to the American people. The information below provides an
understanding of how CDER works to accomplish this mission as it relates to new drug
development and review.
 New Drug Development Process- An interactive chart that provides an overview
of the new drug development process, with an emphasis on preclinical research
and clinical studies conducted by the drug's sponsor.
 Investigational New Drug (IND) Review Process- An interactive chart that
provides an overview of CDER's investigational new drug application process,
including how CDER determines if the product is suitable for use in clinical trials.
 New Drug Application (NDA) Review Process- An interactive chart that provides
an overview of CDER's new drug application review process, including how
CDER determines the benefit:risk profile of a drug product prior to approval for
marketing.