1. ICH GUIDLINES
Prepared By
Arihant Prakash Jain
M. Pharma 1st sem
Guidance By
Prof. Preeti k Suresh Mam
Director Of U.i.o.p Raipur

2. FLOW OF PRESENTATION
• What is ICH
• Object of ICH
• History
• Organization of ICH
• STEPS IN ICH PROCESS
• GUIDELINES
• BENEFIT OF ICH
• Conclusion

3. What is ICH ?
 International Council for Harmonizsation
 ICH is a joint initiative involving both regulator
& research- based industry of the EU, Japan and
the US in scientific and technical discussion of
the testing procedures which are required to
ensure and assess the safety, quality & efficacy of
medicines.

4. Objective of ICH
• To increase international harmonization of technical
requirements to ensure that safe , effective, high
quality medicines are developed.
• To harmonize technical requirements for registration
or marketing approval.
• To promote public health.
• To prevent unnecessary duplication of clinical trials
on humans.
• To minimize the use of animal testing without
compromising safety and effectiveness of drug.

5. History
 Need to harmonize ?
 Industry becoming global
Duplicate test procedure
• Time consuming
• Expensive
Increasing R & D costs
Meeting public demand

6. History cnontd …
• Initiation of ICH
 1980 :- European community
 1989 :- WHO conference on Drug Rehulatory
Authorities, Paris
 1990 :- Birth of ICH, meeting in Brussels
• Europe
• Japan
• US
Topics for harmonization divided into :
safety,efficacy and quality.

7. Evolution of ICH
• 1990:- ICH
• 1999 :- GCG
• 2004 :- RHI
• 2008 :- Expanded GCG
• Note : - In 2015 International Conference on
Harmonization changed its name to the International
Council for Harmonization while becoming a legal entity
in Switzerland.
• On 23 October 2015 ICH conducted the initial meeting
of their new assembly.

9. The Steering Committee
• The Steering Committee, made of six ICH Parties, governs the
ICH, determining the policies and procedures, selecting topics
for harmonization and monitoring progress of harmonization
initiatives. The ICH consists of:
I. European Commission
II. European Federation of Pharmaceutical Industries and
Associations (EFPIA)
III. Ministry of Health, Labour and Welfare (Japan) (MHLW)
IV. Japan Pharmaceutical Manufacturers Association (JPMA)
V. Food and Drug Administration (FDA)
VI. Pharmaceutical Research and Manufacturers of
America (PhRMA)

10. ICH Coordinators
• The coordinators are fundamental to the smooth running of the
ICH and are nominated by each of the six parties
• An ICH Coordinator act as the main contact point with the ICH
Secretariat
ICH Secretariat
The secretariat is primarily concerned with preparations for, and
documentation of ,meetings of the Steering committee as well as
coordination of, preparation for working group and discussion Group
meetings. Information on ICH Guidelines and the general ICH process
can be obtained from the ICH Secretariat

11. ICH Working Group
• Depending on the type of harmonization activity
needed, the steering committee will endorse the
establishment of one of three types of working
group i.e. Expert working group,
Implementation working group, informal
working group

12. Step in the ICH Process
• Step 1 : Drafts are prepared and circulated through
many revision until a “final harmonised draft ” is
completed.
• Step 2 : this draft is signed by the EWG as the agreed
upon draft and forwarded to the steering committee
for signing which signifies acceptance for
consultation by each of the six co-sponsors.
• Step 3 : the three regulatory sponsors initiate their
normal consultation process to receive comment.

13. step 4 : is reached when the steering committee
agrees that there is sufficient scientific consensus on
the technical issues. this endorsement is based on
the signatures from the three regulatory parties to
ICH affirming that the guideline is recommended for
adoption by the regulatory bodies of three regions.
step 5 : The process is complete when the guidelines
are incorporated into national or regional internal
procedure.

14. Guidelines
QUALITY SAFETY EFFICACY MULTIDISLINARY

15. Quality Guidlines
• QUALITY : - those relating to chemical and
pharmaceutical quality assurance(stability testing,
impurity testing etc)

16. Q1A-Q1F STABILITY TESTING
• Q1A :- Stability testing of new drug substance and product.
• Q1B :- Photostability testing of new drug substance
and product.
• Q1C :- Stabilty testing for new dosage forms
• Q1D :- Bracketing and matrixing design for stability
test of new drug
• Q1E :- Evaluation of stability data
• Q1F :- Stability data package for registration and
application in climate zone 3rd & 4th

17. Safety Guidelines
• Those relating to in vitro and in vivo pre clinical
studies(carcinogenicity test , Genotoxicity test)
• S1 – Carcinogenicity studies
• S2 – Genotoxicity studies
• S3- toxicokinetics and pharmacokinetics
• S4-toxicity testing
• S5-reproductive toxicology
• S6-biotechnological product
• S7-pharmacology studies
• S8-immunotoxicology studies
• S9-nonclinical evaluation for anticancer pharmaceuticals
• S10-photosafety evaluation

18. Efficacy Guidelines
• Those relating to clinical studies in human subject
(Dose Response studies , good clinical practices)
• E1 & E2-Clinical safety
• E3-Clinical study report
• E4-Dose response studies
• E5- Ethnic Factor
• E6-good clinical practice
• E7,E8,E9,E10&E11-Clinical Trials
• E12-Guidelines for clinical Evaluation by
therapeutic category
• E14-Clinical Evaluation
• E15&E16-Pharmacogenomics

19. Multidisciplinary Guidelines
• cross-cutting which do not fit uniquely into one of
the above categories
M1-MedDRA Terminolgy
M2-Electronic standards
M3-Non-clinical safety studies
M4-CTD
M5-Data elements & standards for drug dictonaries
M6-Gene theraphy
M7-Genotoxic imourities
M8-eCTD

20. Benefits of ICH
• Streamline R&D Process
• Rapid access to new medicine
• Reference and education material for non ICH
Members
• Implication in developing countries
• Benefits for regulator
• More then 50 harmonized guidelines

21. conclusion
• Ich launched 20 years ago
• Ich bring togeather the drug regulatory authrities of
europe, japan and the US, along with the
pharmacutical trade associations from these three
regions, to discuss scientific and technical aspects of
product registration.
• It is ICH’s mission to achieve greater harmonization
in the interpretation and application of technical
guidelines and requirement for product registration ,
thereby reducing duplication of testing and reporting
carried out during the research and development of
any medicines.