ICH guidelines are very important ans it is given as per CSVTU & PCI syllabus so it is one of the important topic in point of view of competative exams and here i have highlighted the important short forms with the full forms of phrases it is very important for D. & B. pharma students also students have to make sure to read according to syllabus the slide have prepared by GPAT qualifies teacher

1. RANI KASAR QUALITY ASSURANCE
ASSISTANT PROFESSOR ICH GUIDELINES
GRACIOUS COLLEGE OF PHARMACY B.Pharm 6th
sem
ICH GUIDELINES

2. INTRODUCTION
The actual full form of ICH which is generally referred as International Conference on
Harmonization is International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use. It is a project that involves the representatives
from regulatory authorities and pharmaceutical industries of the European Union (EU), Japan
and USA to discuss scientific. and technical issues related to the registration of pharmaceutical
products, ultimately assuring the safety, efficacy and quality of medicines.
ICH was born in April 1990, in a meeting hosted by the European Federation of Pharmaceutical
Industries and Associations (EFPIA) in Brussels.
to develop guidelines for pharmaceutical industries and regulatory authorities, which should be
used when preparing or reviewing the documents related to drug development and approval
required for its marketing.
Harmonization has several benefits in promoting public health as it helps to avoid or eliminate
the need for unnecessary repetition of clinical trials in humans, minimizes the need for animal
testing without compromising on the safety and efficacy of the new drug, enables in making the
regulatory assessment process for NDA easier, thus reducing the time and resources required for
new drug development.

3. • ICH recommends the necessary measures to achieve increased harmonization in interpreting
and applying the technical guidelines and requirements for registration of a new drug product.
• Purpose of ICH
• , the ICH aims to achieve the following.
• 1.To conduct periodic seminars and meetings to enable dialogue between the industry and
regulatory authorities on any differences between the technical aspects of product registration
in EU, USA, and Japan. This helps to ensure that the new and more effective medicines are
timely produced and easily accessible to the patients.
• 2.To make necessary contributions in the protection of public health from an international
point of view.
• 3. To regularly monitor and update the harmonized technical documents.
• 4. To assist in the replacement of current practices with new or improvised approaches that
allow more economical use of human, animal, and mineral resources.
• 5. To communicate and disseminate information on ICH guidelines and their use and to
encourage the implementation of such guidelines.

4. • Participants of ICH
• ICH comprises of six parties which represent the industry and regulatory bodies in the EU,
Japan and USA Thus, the six co-sponsors of ICH are.
• 1.European commission
• 2. European Federation of Pharmaceutical Industries and Associations (EFPIA)
• 3. Ministry of Health, Labour and Welfare (Japan).
• 4. Japan Pharmaceutical manufacture association (JPMA)
• 5 Food and Drug Administration (FDA)
• . Pharmaceutical Research and Manufacturers of America (PHRMA).
• there are 3 observers which represent the non-ICH regions and countries. The observers are
World Health Organization (WHO), Canada (represented by Health Canada) and European
Free Trade Association (EFTA). Apart from these observers, an additional non-voting member
of the ICH is the International Federation of Pharmaceutical Manufacturers Association
(IFPMA).

5. Process of harmonization
• Depending upon the type of harmonization activity to be undertaken, the ICH
harmonization activities are of 4 types;
• Formal ICH Procedure,
• Q&A Procedure,
• Revision Procedure and
• Maintenance Procedure
• Before initiating any harmonization activity, a Concept Paper is required to be drawn which
gives a short summary of the proposal. If necessary, a Business Plan is also required to be
made, which details the benefits and costs of harmonizing the topic which has been
proposed in the Concept Paper. The harmonization activity initiates only when the Concept
Paper and Business Plan (if any) has been approved by the ICH Steering Committee. The
various steps involved in the ICH Formal Procedure are outlined below.

6. • Step -1
• Formal ICH procedure begins with the appointment of a Rapporteur from the industry
members of the Expert Working Group (EWG). The Rapporteur consults the EWG and
prepares an initial draft of the guideline based on the objectives that have been outlined in the
Concept Paper. The initial draft is circulated within the EWG for any comments. If all the
members of the group have consented to the draft, 1. then a Step 2 Experts Sign-off sheet is
signed and the same is forwarded to the Steering Committee (SC). If a consensus has not been
reached within the specified time frame, then the SC might decide to extend the deadline,
suspend or entirely drop the project
• Step -2
• based on the report submitted by the EWG if the steering committee is satisfied then the draft
guidelines are signed by the SC as step – 2 final document.
• Step - 3
• The draft that has been approved by the SC is published in the three regions (USA, EU and
Japan) by the respective governments to garner any comments. Moreover, comments on the
draft are also welcomed by the companies

7. • authorities and associations located in the non-ICH regions, after the draft has been
circulated to these regions by the WHO and IFPMA. The results obtained from
consultations and discussions are put forward to the same EWG which had taken part in
Step 1. This time a new Rapporteur is appointed from the regulatory industry but preferably
from the same region as the previous Rapporteur. The same procedure as described under
Step 1 is initiated to incorporate the results of consultation into the Step 2 Final Document.
If both the industry and regulatory members of the EWG agree that there has been no
change in the Step 2 Final Documents even after consultation or that any changes made
have been consented, then the regulatory experts of the EWG sign a Step 4 Experts
Document, which is then submitted to the SC.
• Step 4
• Step 4 is reached when the SC is of the opinion that there is sufficient scientific consensus
on the technical issues. If one industry raises an objection to the adoption of the guideline as
it thinks that the revised document differs from the originally consented draft, then the
revised document is again submitted to EWG for further discussion and consultation.
Finally the Step 4 Final Document is certified by the SC and is called an ICH Harmonised
Tripartite Guideline.

8. • Step 5
• The final step in the process is the regulatory implementation of the ICH Harmonized Tripartite
Guideline. Prior to implementation, these guidelines should be incorporated into national or
regional internal procedures.
• STRUCTURE OF ICH GUIDELINES
• The ICH is constituted by the
1) ICH Steering Committee,
2) ICH Coordinators,
3) ICH Secretariat, and
4) ICH Working Groups.
ICH Steering Committee- Each of the six co-sponsors of the ICH has two votes on the ICH Steering
Committee. It is the main governing body of the ICH. Its functions are to outline the procedures and policies
for ICH, to select a topic for harmonization and to determine the progress being made in the harmonization
initiatives. Each observer notices a member who has voting rights to the meetings of the Steering
Committee.

9. • .ICH Coordinators- Every co-sponsor of the ICH nominates an ICH coordinator, who is
essential to ensure the smooth running of the ICH. These coordinators act as a connecting
link with the ICH Secretariat. Their function is to ensure that the ICH documents have been
properly distributed to the correct individuals of their respective party and should also
monitor whether the respective parties are completing their tasks within the set deadlines.
Since there occurs structural differences within the EU, ICH technical coordinators are
appointed from the European Medicines Agency (EMA). Due to the same reason existing in
the Ministry of Health, Labour, and Welfare (MHLW), such coordinators are also appointed
from the Pharmaceuticals and Medical Devices Agency (PMDA). These ICH technical
coordinators are required to support the coordinators, and by using their scientific expertise,
help the members of ICH Steering Committee in accomplishing their task. These ICH
technical coordinators act as a connecting link between the ICH coordinators and the experts
of EMA or MHLW as well as with that of the ICH Secretariat.
• . ICH Secretariat- ICH Secretariat has its headquarters at Geneva, Switzerland. It provides
administrative support to the ICH Steering Committee. Its functions include arranging the
meetings of the ICH Steering Committee, documenting the minutes of the meeting, and
coordinating the preparations for conducting the meeting of working groups and discussion
groups.

10. • ICH Working Groups- There are different types of ICH working groups such as -Expert
1. Working Groups (EWG),
2. Implementation Working Group (IWG),
3. Informal Working Groups and
4. Discussion Groups.
• Depending upon the type of harmonization activity required, the Steering Committee can
allow the constitution of any one of the Working Groups. Working groups are constituted by
Topic Leaders and generally even Deputy Topic Leaders, who are nominated by each of the
six co-sponsors. ICH also allows the observers, representatives from pharmacopoeial
authorities, and generic and OTC drug industries to participate in the working groups. After a
topic for harmonization is selected, a working group is appointed by the ICH Steering
Committee. This working group is required to review the differences in requirements existing
between the 3 regions (USA, EU, and Japan) and to arrive at a common scientific consensus.

11. • Overview of QSEM
• The guidelines given by ICH are divided into the following 4 categories.
• 1. Quality Guidelines (Q Series)- These guidelines relate to the chemical and quality
assurance aspects of the pharmaceutical industry such as conduct of stability studies,
impurity testing, Good Manufacturing Practices (GMP), risk management etc.
• Q1A-Q1F: Stability Testing
• Q1A (R2) Stability Testing of New Drug Substances and Products
• Q1B: Photostability Testing of New Drug Substances and Products
• Q1C: Stability Testing for New Dosage Forms
• Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances
and Products
• QIE: Evaluation of Stability Data
• QIF: Stability Data Package for Registration Applications in Climatic Zones III and IV.
• Q2 : Validation of Analytical Procedure

12. • Q2 : Validation of Analytical Procedure
• Q3A-Q3D Impurities
• Q3A(R2) Impurities in New Drug Substances
• Q3B (R2) Impurities in New Drug Products
• Q3C (RS): Impurities Guidelines for Residual Solvents
• Q3D : Impurities Guidelines for Metal Impurities
• Q4-Q4B Pharmacopoeias
• Q5A-QSE: Quality of Biotechnological Products
• Q6A-Q6B: Specifications
• Q7 : Good Manufacturing Practice
• Q8 : Pharmaceutical Development
• Q9 : Quality Risk Management
• Q10 Pharmaceutical Quality System
• Q11 : Development and Manufacture of Drug Substances

13. • Q12 Life Cycle Management
• Safety Guidelines (S series)- These guidelines provide guidance on animal and in vitro
testing.
• SIA-SIC: Carcinogenicity Studies
• S2 : Genotoxicity Studies
• S3A-S3B: Toxico-kinetics and Pharmacokinetics
• S4: Toxicity Testing
• S5: Reproductive Toxicology
• S6: Biotechnological Product.
• S7A-S7B: Pharmacological Studies
• S8: Immuno-toxicological Studies
• S9:Non-Clinical Evaluation for Anticancer Pharmaceuticals
• S10 Photo-safety evaluation
• S11 Non-clinical paediatric safety

14. • E1-E2F: Clinical Safety
• E3: Clinical Safety Reports
• E4: Dose-Response Studies
• E5 : Ethnic Factors
• E6: Good Clinical Practice
• E7-E11: Clinical Trials
• E12 : Clinical Evaluation by Therapeutic Category
• E14 : Clinical Evaluation
• E15-E16: Pharmacogenomics
• E17 : Multiregional clinical trials
• E18: Genomic sampling

15. • Multidisciplinary Guidelines (M Series)
• These guidelines are on those extra topics which do not fit into the categories of
quality, safety and efficacy. Examples include Common Technical Documents(CTD),
ICH medical terminology (Med DRA) etc.
• MI Med DRA Technology
• M2 : Electronic Standards for the Transfer of Regulatory Information
• M3 : Non-clinical Safety Studies
• M4 : Common Technical Documents
• M5 : Data Elements and Standards for Drug Dictionaries
• M6 : Gene Therapy
• M7 : Genotoxic Impurities
• M8 : Electronic common technical document
• M9 : Biopharmaceutics classification
• M10 : bioanalytical method analysis