ICH - International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. It was created in 1990. ICH established in 1990 as a joint initiative involving both regulators and research-based industry representatives of the European Union, Japan and the USA in scientific and technical discussion of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.

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INTERNATIONAL CONFERENCE OF HARMONISATION [ICH]
INTRODUCTION
ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
industry representatives of the European Union, Japan and the USA in scientific and technical
discussion of the testing procedures required to assess and ensure the safety, quality and
efficacy of medicines.
HISTORY OF ICH
INITIATION OF ICH
The birth of ICH took place at meeting April1990 hosted by European federation of
pharmaceutical industries Association (EFPIA), in Brussels
THE EARLY MEETINGS
At the first SC meeting of ICH it was decided that the topics selected for harmonization would
be divided in to safety, quality and efficacy set up of six-party Expert Working groups (EWGs).
COMMITMENT & PROCESS
The commitment to ICH was set out in a Steering Committee statement from the meeting in
Tokyo, October 1990.
Process statement deals with the
 Clinical trials with animals and humans.
 Recognizing the substantial progress.
 To look on existing issues as well as past topics and it’s relation with future aspects.
PURPOSE
 More economical use of human, animal and material resources.
 Reduce duplicate testing.
 Eliminate unnecessary delays in the availability of new medicines.

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 Aim to produce a single set of technical requirements for the registration of new drug
product.
GOALS
 To promote international harmonization.
 To make information available on ICH, ICH activities and ICH guidelines to any
country or company.
 To strengthen the capacity of drug regulatory authorities and industry to utilize them.
MEMBERS
ICH is comprised of representatives from six parties that represent the regulatory bodies and
research-based industry in the European Union, Japan and the USA.
 Additional members include Observers from the World Health Organization (WHO),
European Free Trade Association ( EFTA ) , and Canada.
 The Observers represent non-ICH countries and regions.
ICH
PARTIES
JAPAN EUROPE USA
• The Ministry of
Health, Labour
& Welfare
(MHLW)
• Japan
Pharmaceutical
Manufacturers
Association
(JPMA)
 The European
 Commission (EC)
European
Federation of
Pharmaceutical
Industries and
Associations
(EFPIA)
• The Food & Drug
Administration
(FDA)
• The
Pharmaceutical
Research and
Manufacturers of
America (PHRMA)

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 The International Federation of Pharmaceutical Manufacturers & Associations
(IFPMA) has been closely involved with ICH since its inception and participates as a
non-voting member.
ICH STRUCTURE
 ICH Steering Committee,
 ICH Coordinators,
 ICH Secretariat and ICH Working Groups
 ICH MedDRA Management Board
ICH HARMONIZATION PROCESS
1. Overview.
2. Initiation of Harmonization action.
3. Full ICH process for major Harmonization topics.
4. Abbreviated process for maintenance of ICH agreement.
5. Maintenance Procedure.
INITIATION OF HARMONIZATION ACTION:
 Proposals for Harmonization action
 Preparation of concept paper
 Selection of procedure
STEPS
The formal ICH procedure consists of 5 Steps:
Step 1: Consensus Building.
Step 2: Confirmation of six-party consensus.
Step 3: Regulatory Consultation and Discussion.
Step 4: Adoption of an ICH Harmonized Tripartite Guideline.
Step 5: Implementation.

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ABBREVIATED PROCESS FOR MAINTENANCE OF ICH AGREEMENT
REVISION PROCEDURE
 This procedure is almost identical to the formal ICH i.e. 5 ICH steps.
 The revision of a guideline is designated by the letter R1 after the usual denomination
of the guideline.
 When guideline is revised more than once, the document will be named R2,R3,R4 etc
at each new revision.
MAINTENANCE PROCEDURE
 This procedure is currently applicable to the Q3C Guideline on residual solvents and
M2 recommendations
TYPES OF ICH
Q - "Quality" Topics, i.e., those relating to chemical and pharmaceutical Quality Assurance.
S - "Safety" Topics, i.e., those relating to in vitro and in vivo studies.
E - "Efficacy" Topics, i.e., those relating to clinical studies in human subject.
M - "Multidisciplinary" Topics, i.e., cross-cutting Topics which do not fit uniquely into one of
the above categories.
QUALITY GUIDELINES
Q1A - Q1F Stability
Q2 Analytical Validation
Q3A - Q3D Impurities
Q4 - Q4B Pharmacopoeias
Q5A - Q5E Quality of Biotechnological Products
Q6A- Q6B Specifications
Q7 Good Manufacturing Practice
Q8 Pharmaceutical Development
Q9 Quality Risk Management
Q10 Pharmaceutical Quality System

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Q11 Development and Manufacture of Drug Substances
SAFETY GUIDELINES
EFFICACY GUIDELINES
E1-E2F Clinical Safety
E3 Clinical Study Reports
E4 Dose Response Studies
E5 Ethnic Factors
E6 Good Clinical Practice
E7-E11 Clinical Trials
E12 Guidelines for Clinical Evaluation by Therapeutic Category
E14 Clinical Evaluation
E15-E16 Pharmacogenomics
S1A Need for carcinogenicity study
S1B Testing for carcinogenicity of pharmaceutical product
S2A Guidance on specific aspects of regulatory genotoxicity test for pharmaceutical
product
S3 Note for guidance on toxicokinetics
S4 Duration of chronic toxicity testing in animal
S5 Detection of toxicity to reproduction
S6 Preclinical safety evaluation

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MULTIDISCIPLINARY GUIDELINES
M1 MedDRA (medical dictionary for regulatory activities)
M2 ESTRI(Electronic Standards for transfer of Regulatory Information)
M3(R2) Non clinical Safety Studies for the conduct of Human clinical Trials and
Marketing Authorization for Pharmaceuticals
M4 CTD(The Common Technical Document)
M5 Data Element and Standards for Drug Dictionaries
REFERENCE
 Kuchekar B.S., Khadatare A.M.,Forensic Pharmacy, Nirali Publication, page no. 17.16-
17.25.
 Itkar S., “Pharmaceutical Management”, Nirali Prakashan , First edition, page
no.18.10.
 www.ich.org
 www.fda.gov/regulatoryinformation/guidances.
 www.ipstherapeutique.com
SAGAR KISHOR SAVALE
avengersagar16@Gmail.Com