ICH (QSEM Guidelines)

BHARAT PHARMACEUTICAL TECHNOLOGY
TOPIC: OVERVIEW OF ICH GUIDELINES
PREPARED BY
Name:- Bishal Bhattacharjee
Stream:- B.Pharm
Year:- 4th year/ Final year
Sem:- 7th sem
CONTENTS
•Introduction
•Objective of ICH
•QSEM guidelines
•Common Technical Document
•Organization & Advantages of Common Technical Document
•Silent benefits & Limitations of Common Technical
Document
•Electronic Common Technical Document
•Benefits & Advantages of Electronic Common Technical
Document
INTRODUCTION
The International Council for Harmonization(ICH) of technical

requirements for pharmaceuticals of human use brings together the
medicines regulatory authorities and pharmaceutical industry
around the world.
ICH is a joint initiative involving both regulators and research

based industry representatives of the European Union, Japan and
the US in scientific and technical discussions of the testing
procedures required assess and ensure safety, quality and efficacy
of medicines.
OBJECTIVE OF ICH
To increase international harmonization of technical
requirements to ensure safe, effective and 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.
QSEM GUIDELINES
Q: Quality guidelines- It includes stability, impurities,

testing and GMP
S: Safety guidelines- It include carcinogenicity,
genotoxicity, reprotoxicity.
E: Efficacy guidelines- It includes clinical pharmacy
genomics.
M: Multidisciplinary guidelines- It includes medical
dictionary or regulatory activities, electric standard on
clinical safety studies, common technical document.
COMMON TECHNICAL DOCUMENT(CTD)
CTD is an internationally agreed “well structured common

format” for the organization of the technical requirements that
is to be submitted to the regulatory authority as an application
for the registration of pharmaceuticals for human use in all
three ICH regions:
1. European Medicines Agency(EMEA, Europe)
2. Food & Drug Administration(FDA, USA)
3. Ministry of health, labor & welfare(MHLW, Japan)
In July 2003, the CTD became the mandatory format for new
drug application in the EU & Japan and the strongly
recommended format of choice for NDAs submitted to the
FDA. It has been adopted by several other countries including
Australia, Canada & Switzerland(2004).
ORGANIZATION OF CTD
It is organized into:
1. Module A: General Information
2. Module B: CTD summaries
3. Module C: Quality
4. Module D: Nonclinical study reports
5. Module E: Clinical study reports
ADVANTAGES OF CTD
1. To save time and resources

2. To facility regulatory review and
communications
3. Appropriate for the data
4. Easy to understand and evaluation of
data
SILENT BENEFITS OF CTD
• More "reviewable” applications
• Complete, well-organized submissions
• More predictable format
• Easier exchange of information
• Easier analysis across applications
LIMITATIONS OF CTD
• CTD is only a format, its not a single dossier with a single
content
• Legal requirements differ in the different regions
• Pharmacopoeias are not harmonized
• Applicant may have regional preferences
• ICH guidelines have not yet harmonized in all requirements
ELECTRONIC COMMON TECHNICAL DOCUMENT
The electronic Common Technical Document(eCTD) is an
interface and international specification for the Pharmaceutical
Industry to agency transfer of regulatory information. The
specification is based on the Common Technical
Document(CTD) format and was developed by the International
Council for harmonisation(ICH).
The eCTD allows submission builders to map to documents

within and across all submissions and applications. This feature
can save time and money, but only if it is set up and handled
effectively from the beginning of the product IND application.
BENEFITS OF eCTD
1. Reusable content
2. Better document management
3. Metadata corrections
4. Better life-cycle capabilities
ADVANTAGE OF eCTD
1. Reviewers are already familiar with the content and
document standards
2. Local affiliates can review updates in real-time
3. Handling, managing & archiving trial and
document essential information is less time-
consuming
4. Documents are easily accessible via search &
tracking
THANK YOU

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BHARAT PHARMACEUTICAL TECHNOLOGY

TOPIC: OVERVIEW OF ICH GUIDELINES

The International Council for Harmonization(ICH) of technical

ICH is a joint initiative involving both regulators and research

Q: Quality guidelines- It includes stability, impurities,

CTD is an internationally agreed “well structured common

1. To save time and resources

The eCTD allows submission builders to map to documents

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