This document provides a summary of ICH (International Conference on Harmonisation) guidelines. It discusses the purpose of ICH in harmonizing technical requirements for pharmaceutical registration across regions to ensure safety and efficacy. ICH guidelines cover topics like nonclinical safety studies, clinical safety data, stability testing, and electronic submission of safety reports. The document outlines the structure of ICH including its steering committee and working groups and describes how guidelines are developed and can be used by regulators and industry globally.

1. Chapter 09
ICH GUIDELINES and qbd
By
Mr.Prashant Jorapur M.pharm
Asst.professor
Dept. of pharma technology

2. INTRODUCTION
 The realisation that it was important to have an
independent evaluation of medicinal products before they
are allowed on the market was reached at different times
in different regions.
 In the United States a tragic mistake in the formulation of
a children's syrup in the 1930s was the trigger for setting
up the product authorisation system under FDA.
 In the 1960s and 1970s saw a rapid increase in laws,
regulations and guidelines for reporting and evaluating
the data on safety, quality and efficacy of new medicinal
products.

3. ICH is the "International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for
Human Use".
It is a joint initiative involving both regulators and research-
based industry representatives of European, Japan and the
USA.
scientific and technical discussions were made for testing
procedures required to assess and ensure the safety, quality and
efficacy of medicines.

4. PURPOSE
 The objective of ICH is to ensure that safe, effective, and
high quality medicines are developed and registered in the
most efficient and cost-effective manner.
 These activities have been undertaken to promote public
health, prevent unnecessary duplication of clinical trials in
humans, and minimize the use of animal testing without
compromising safety and effectiveness.
 The goal of ICH is to promote international harmonisation by
bringing together representatives from the three ICH regions
(EU, Japan and USA) to discuss and establish common
guidelines.

5. Another goal of ICH is to make information available on
ICH, ICH activities and ICH guidelines to any country or
company that requests the information.
Location
ICH does not have "offices" as such because it is a voluntary
cooperative effort of cosponsors from the three regions. The
ICH Secretariat is in Geneva.
The biennial meetings and conferences of the ICH Steering
Committee rotate between the EU, Japan, and the USA.

6. Members
 In Japan, the members are the Ministry of Health, Labour and
Welfare (MHLW), and the Japan Pharmaceutical Manufacturers
Association (JPMA).
 In Europe, the members are the European Union (EU), and the
European Federation of Pharmaceutical Industries and Associations
(EFPIA).
 In the USA, the members are the (FDA), and the Pharmaceutical
Research and Manufacturers of America (PhRMA).
 Additional members include Observers from the (WHO), European
Free Trade Association (EFTA), and Canada.

7. STRUCTURE OF ICH
The ICH structure consists of the ICH Steering Committee, ICH
Coordinators, ICH Secretariat and ICH Working Groups.
The Steering Committee is the body that governs the ICH,
determines the policies and procedures for ICH, selects topics for
harmonisation and monitors the progress of harmonisation
initiatives.
The ICH Secretariat operates from the offices in Geneva,
Switzerland, and provides support to the ICH Steering
Committee.
Information on ICH Guidelines and the general ICH process can
be obtained from the ICH Secretariat.

8. EFFICACY GUIDELINES:
 The objective of this guideline is to present an accepted set of
principles for the safety evaluation of drugs intended for the long-
term treatment (chronic or repeated intermittent use for longer than 6
months) of non-life-threatening diseases.
 The safety evaluation during clinical drug development is expected
to characterise and quantify the safety profile of a drug over a
reasonable duration of time consistent with the intended long-term
use of the drug.
 Thus, duration of drug exposure and its relationship to both time and
magnitude of occurrence of adverse events are important
considerations in determining the size of the data base necessary to
achieve such goals.

9.  For the purpose of this guideline, it is useful to distinguish between
clinical data on adverse drug events (ADEs) derived from studies of
shorter duration of exposure and data from studies of longer duration,
which frequently are non-concurrently controlled studies.
 It is expected that short-term event rates will be well characterised.
 Events where the rate of occurrence changes over a longer period of
time may need to be characterised depending on their severity and
importance to the risk-benefit assessment of the drug.
 The safety evaluation during clinical drug development is not
expected to characterise rare adverse events, for example, those
occurring in less than 1 in 1000 patients.

10.  The design of the clinical studies can significantly influence the
ability to make causality judgements about the relationships
between the drug and adverse events.
SAFETY GUIDELINES:
Objectives of the Guideline
The purpose of this document is to recommend international
standards for, and promote harmonisation of the nonclinical safety
studies recommended to support human clinical trials of a given
scope and duration as well as marketing authorization for
pharmaceuticals.

11.  This document applies to the situations usually encountered
during the development of pharmaceuticals and should be
viewed as general guidance for drug development.
 Nonclinical safety studies and human clinical trials should be
planned and designed to represent an approach that is
scientifically and ethically appropriate.
 This guidtlines should facilitate the timely conduct of clinical
trials, reduce the use of animals in accordance with the 3R
(reduce/refine/replace) principles and reduce the use of other
drug development resources.

12. - Although not discussed in this guidelines, consideration should be
given to use of new in vitro alternative methods for safety
evaluation.
- These methods, if validated and accepted by all ICH regulatory
authorities, can be used to replace current standard methods.
- This promotes safe, ethical development and availability of new
pharmaceuticals.

13. STABILITY TESTING OF
NEW DRUG SUBSTANCES AND PRODUCTS
• The guideline addresses the information to be submitted in
registration applications for new molecular entities and
associated drug products.
• Specific details of the sampling and testing for particular dosage
forms in their proposed container closures are not covered in
this guideline.
• The purpose of stability testing is to provide evidence on how
the quality of a drug substance or drug product varies with time
under the influence of a variety of environmental factors such as
temperature, humidity and to establish a re-test period for the
drug substance or a shelf life for the drug product and
recommended storage conditions.

14. Representation of the Electronic ICSR
The ICH community agreed that the ICSRs, including pre-
marketing and post-marketing adverse drug reactions and adverse
drug events, should be gathered, managed, and distributed
electronically, but there was a need to find consensus on how this
should be done.
The objective was to represent the document in a way that would
make possible transfer of its contents from one database to
another.
In addition, the representation should use an international
standard that is platform, application and vendor independent.

15. GUIDELINES USE:
Industry and governments in ICH and non-ICH countries can use the
ICH guidelines to address technical issues during the product
development process.
In addition to providing state-of-the-art guidance, the guidelines may
well also serve as teaching tools.
Harmonised ICH guidelines can reduce duplication in meeting
technical requirements, thereby saving financial and material
resources.

16. THANK U…