đ What is ICH? A Friendly Guide to the International Council for Harmonisation
- Ashutosh Srivastava
- Apr 9
- 2 min read
If youâre a pharmacy student, an industry fresher, or a professional preparing for a GMP audit or regulatory interview, understanding ICHÂ is essential.
But donât worryâweâve got you covered. In this article, weâll break down the International Council for Harmonisation (ICH)Â in the simplest way possible.
What is ICH?
ICHÂ stands for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
It is a unique international organization that brings together regulatory authorities and pharmaceutical industry experts to develop common guidelines that ensure:
Safety
Efficacy
Quality
Why Was ICH Created?
Before ICH, each country had different rules and standards for drug approval, which caused:
Duplication of research work
Delays in drug approval
Increased cost of bringing medicines to market
To solve this, ICH was founded in 1990Â with a simple goal:
âOne guideline, accepted globally.â
đ§© Who Are the Key Members of ICH?
The ICH includes both Regulatory Members (like the FDA, EMA, PMDA) and Industry Members (like PhRMA, EFPIA, JPMA). Some major members are:
đ What Are ICH Guidelines?
ICH Guidelines are categorized into four main areas:
Code | Area Covered |
Q | Quality (e.g., Q8 - Pharmaceutical Development, Q9 - Quality Risk Management) |
S | Safety (e.g., S1 - Carcinogenicity Studies) |
E | Efficacy (e.g., E6 - Good Clinical Practice) |
M | Multidisciplinary (e.g., M4 - Common Technical Document - CTD) |
đ How Does ICH Affect Your Pharma Career?
Whether you're in R&D, QA, Regulatory Affairs, or Production, understanding ICH guidelines is vital for:
Drug development and approval
GMP compliance and audits
Quality documentation
Regulatory submissions (like CTD)
đĄ Quick Summary
ICHÂ harmonizes global pharmaceutical guidelines.
Focuses on Quality, Safety, and Efficacy.
Helps ensure faster, safer drug development worldwide.
Essential for students, freshers, and professionals aiming for long-term success in pharma.
đ Want to Learn ICH in a Quick & Easy Way?

If you want to master ICHÂ without going through hundreds of pages, grab our eBook:
â Perfect for:
Pharmacy students (D.Pharm, B.Pharm, M.Pharm)
Industry freshers preparing for interviews
Professionals working in QA, QC, RA, or R&D
đ Click here to buy the eBook now and strengthen your pharma fundamentals.
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