ICH guidelines are a set of guidances to ensure safe, effective and high-quality medicines are developed and registered efficiently. These guidelines have been adopted by regulatory authorities throughout the world.

1. AN INTRODUCTION TO ICH
(International Council for
Harmonisation)
Manimegalai.G
M.Pharm
Department of Pharmaceutical chemistry
5/17/2023 Department of Pharmaceutical chemistry 1

2. ICH
International council for Harmonisation of technical requirements for
registration of pharmaceuticals for human use.
It is an agreement between the European Union(EU), Japan and the
United States(US).
Joint initiative between government regulators and industry
manufacturers.
It is a harmonize regulatory requirements for the testing, application
and approval process of pharmaceutical medications.
5/17/2023 Department of Pharmaceutical chemistry 2

3. HISTORICAL OVERVIEW
First attempt by the European Commission(EC) member nations
during the 1980’s.
EC began bilateral discussions with both Japan and the united states.
Specific plan began to materialize at the World Health Organisation
(WHO) conference on Drug Regulatory Authorities in Paris in 1989
ICH was created in April 1990 at a meeting in Brussels.
5/17/2023 Department of Pharmaceutical chemistry 3

4. NEED FOR HARMONISATION
• Rapid increase in laws, regulations and gudelines for testing safety ,
quality and efficacy of new products.
• Different technical requirements by regulatory agencies , although
fundamental guiding principles same.
• Industry becoming global.
• Duplication of time consuming and expensive testing.
5/17/2023 Department of Pharmaceutical chemistry 4

5. GOALS
Decrease country -to-country differences in guidelines.
Decrease differences between regulatory authorities.
TARGET
Streamline drug development and regulatory process
Increase efficiency and enforcement of GMP, GLP and GCP
guidelines.
5/17/2023 Department of Pharmaceutical chemistry 5

6. ICH GUIDELINES (OVERVIEW OF QSEM)
5/17/2023 Department of Pharmaceutical chemistry 6

7. Q- QUALITY GUIDELINES
 Q1- Stability
 Q2-Analytical validation
 Q3-Impurities
 Q4-Pharmacopeia
 Q5-Quality of Biotechnology Products
 Q6- Specifications
 Q7- Good Manufacturing Guide for Active Pharmaceutical
Ingredients
 Q8- Pharmaceutical development
5/17/2023 Department of Pharmaceutical chemistry 7

8.  Q9- Quality Risk management
 Q10- Pharmaceutical quality system
 Q11- Development and Manufacture of drug substances (Chemical
Entities Biotechnological / Biological Entities)
 Q12- Life Cycle Management
5/17/2023 Department of Pharmaceutical chemistry 8

9. S-SAFETY GUIDELINES
 S1A-S1C – Carcinogenicity studies
 S2 – Genotoxicity Studies
 S3A-S3B- Toxicokinetics ad pharmacokinetics
 S4- Toxicity testing
 S5- Reproductive toxicology
 S6- Biotechnological products
 S7A-S7B- Pharmacology studies
 S8-Immunotoxicology studies
5/17/2023 Department of Pharmaceutical chemistry 9

10.  S9- Nonclinical evaluation for anticancer pharmaceuticals
 S10- Photo safety evaluation
 S11- Nonclinical paediatric safety
5/17/2023 Department of Pharmaceutical chemistry 10

11. E-EFFICACY GUIDELINES
E1- Clinical safety for drugs used in long term treatment
E2A-E2F- Pharmacovigilance
E3- Clinical study reports
E4- Dose – Response studies
E5- Ethnic Factors code
E6- Good clinical practice
E7- Clinical trials in geriatric population
E8- General considerations for clinical trials
5/17/2023 Department of Pharmaceutical chemistry 11

12.  E9- Statisticsl principles for clinical trials
 E10- Choice of control group in clinical trials
 E11- Clinical trials in Paediatric population
 E12- Clinical evaluation by therapeutic category
 E14- Clinical evaluation of QT
 E15- Definition of pharmacogenetics
 E16- Qualification of genomic biomarkers
 E17- Multiregional clinical trials
 E18- Genomic sampling
 E19- Safety data collection
5/17/2023 Department of Pharmaceutical chemistry 12

13. M- MULTIDISCIPLINARY GUIDELINES
 M1- MedDRA terminology
 M2- Electronic standards
 M3- Non clinical safety studies
 M4- Common technical document
 M5- Data elements and standards for drud dictionaries
 M6- Gene therapy
 M7- Genotoxic impurities
 M8- Electron common technical document(eCTD)
5/17/2023 Department of Pharmaceutical chemistry 13

14.  M9- Biopharaceutics classification system based Biowaivers
 M10- Bioanalytical method validation
5/17/2023 Department of Pharmaceutical chemistry 14