The document summarizes the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH is a joint initiative between regulators and industry to establish and harmonize technical standards for pharmaceutical drug development and regulation. The ICH has guidelines on quality, safety, efficacy, and multidisciplinary topics. Some key achievements and guidelines discussed include standards for stability studies, impurities testing, risk-based pharmaceutical quality management, medical terminology standardization (MedDRA), common technical document format (CTD), and electronic data standards. Dates of finalization are provided for numerous ICH guidelines.

1. By SGS

2.  ICH is a 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,
efficacy, and multidisciplinary of medicines.

3.  ICH guidelines and topics
 Quality (Q)
 Safety (S)
 Efficacy (E)
 Multidisciplinary (M)

4. ICH TOPICS
QUALITY
(Q)
SAFETY
(S)
EFFICACY
(E)
MULTI
DISCIPLINARY
(M)

6. Harmonization Achievements
In the quality area include
Pivotal milestones
such as the conduct
of stability studies. defining
relevant thresholds for
impurities testing
and a more flexible approach
to
pharmaceutical quality
based on
good manufacturing
practice(GMP) risk
management

10. This guide line has been finalised on 2nd
feb,2002

16. This guide line has been finalised on4th
july, 1997

17. This guide line has been finalised on
march, 2008

18. EFFICACY GUIDELINES

20. This guide line has been finalized on
4th Oct 1994

21. This guide line has been finalized on
Oct 1994

23. This guide line has been finalized on
Nov 1996

24. E2D Post Approval safety Data Management :
Definitions and Standards for Expedited Reporting
This guide line has been finalized on Nov
2003
It provides a standardized procedure for
Post Approval safety Data Management :
Definitions and standards for Expedited
Reporting To relevant authority

25. E2E Pharmacovigilance planning
This guide line has been finalized
on Nov 2004
It is intended to aid in planning
pharmacovigilance activities,
especially in preparation for the early
post marketing period of a new drug

26. MULTIDISCIPLINARY
GUIDELINES

27. MULTIDISCIPLINARY
GUIDELINES
It includes the ICH medical terminology,
the Common Technical Document (CTD)
and the development of Electronic
Standards for the Transfer of Regulatory
Information(ESTRI)

28. MedDRA Terminology M1
MedDRA Medical Dictionary for
Regulatory Activities
MedDRA was approved on 1997
and Terminology was launched on
1999

29. Electronic Standards M2
ESTRI: Electronic Standards for the Transfer
of Regulatory Information
It was approved by the committee in1994
Objective of facilitating international
electronic communication by evaluating and
recommending for the requirements of the
pharmaceutical companies and regulatory
authorities

30. Nonclinical safety studiesM3
Guidance on nonclinical safety studies for
the conduct of human clinical trials and
marketing authorization for
pharmaceuticals
It was approved on June 2009
It represents the consensus that exists
regarding the type and duration of non
clinical safety studies and their timing to
support the conduct of human clinical
trials and marketing authorisation for
pharmaceuticals

31. Common Technical Document M4
It was approved on Nov 2000
Data Elements and Standards for Drug Dictionaries
M5
It was approved on 2004

32. Gene Therapy M6
It was approved on 2009
Virus and Gene therapy vector shedding and
Transmission
It provides recommendations to industry and
Regulators on non clinical and clinical studies and
guidance on use of analytical assays for the
detection and characterization of shed virus

33. Genetoxic Impurities M7
Assessment and control of DNA Reactive
impurities in pharmaceuticals to limit
potential carcinogenic Risk
It was approved in June 2010
It was proposed to offer guidance on analysis of
structure activity relationships for genotoxicity