ICHINTERNATIONAL

CONFERENCE ON

HARMONIZATIONBy

TEJASWINI4th Year B.Pharmacy

WHAT IS ICH? 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.

FORMAT OF APPLICATION ICH guidelines and topics

Quality (Q)Safety (S)Efficacy (E)Multidisciplinary (M)

STABILITY CARCINOGENICITY DOSE RESPONSE MEDDRA TESTING TESTING STUDIES ESTRI IMPURITY GENOTOXICITY GOOD CLINICAL

CTD TESTING TESTING PRACTICES

ICH TOPICS

QUALITY(Q)

SAFETY(S)

EFFICACY(E)

MULTI DISCIPLINAR

Y(M)

QQUALITY GUIDELINES

Quality Guidelines

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

QAQA(R2) stability testing of new drug substances and

products

This guide lies has been revised

In second time in february 2003

The guidelines provides recommendations on stability testing protocols including temperature,

humidity and trial climatic zone

QBQB Stability Testing : Photo stability testing of

new drug substances and products

This guide line has been finalised on 4th nov, 1996

This guide line gives guidance on the

basic testing protocol required to evaluate the sensibility and stability of new drugs and

products

QCQC Stability testing for New Dosage Forms

This guide line has been finalised on 4th nov, 1996

This guideline gives guidance for new formulations of already approved medicines

Defines the circumstances under which reduced stability data can be accepted

QDQD Bracketing and Matrixing Designs for

Stability testing of New Drug Substances and

ProductsThis guide line has been finalised on 2nd feb,2002

This guide line describes general principles for reduced stability testing and provides

examples of bracketing and matrixing designs

QEQE Evaluation of Stability Data

This guide line has been finalised on 4th feb, 2003

Explaining possible situations where extrapolation of retest periods

beyond the real time data may be appropriate.

It provides examples of statistical approaches

tostability data analysis

QF

Stability Data Package for Registration Applications in Climatic Zones

The ICH Steering committee endorsed the with drawl of this

guide line at its meeting in Yokohama June 2006

QF

SAFETY GUIDELINES

S

Safety GuidelinesThe ICH has produced a

comprehensive set of safety guidelines to uncover

potential risks like carcinogenicity and reprotoxicity

S A S A need for Carcinogenicity studies of

Pharmaceuticals

This guide line has been finalised on nov, 1995

This provides a consistent definition of the circumstances under which it is necessary to undertake carcinogenicity studies on new drugs

These recommendations take in to account to know the risk factors as well as the

intended indications and duration of exposure

S BSB Testing for carcinogenicity of Pharmaceuticals

This guide line has been finalised on4th july, 1997

Provides guidance on the need to carry outcarcinogenicity studies in both mice and rats

Guidance is also given on alternate testing procedures which may be applied

without jeopardizing safety

S CS C Dose selection for carcinogenicity studies of

Pharmaceuticals

This guide line has been finalised on march, 2008

Addresses the criteria for the selection of the high dose to be used incarcinogenicity studies

on new therapeutic agents to harmonise current practices and improve the design of studies

EFFICACY GUIDELINES

E

EFFICACY GUIDELINES

The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of

clinical trials. It also covers novel types of medicines

derived from biotechnological processes and the useof pharmacogenetics / pharmacogenomics

techniques to produce better targeted medicines.

E 1E 1 The extent of population exposure to assess

clinical safety for drugsintended for long term treatment of non life

threatening conditions

This guide line has been finalized on 4th Oct 1994

It gives the recommendations in the number of patients and duration Exposure for the

safety evaluation of drugs intended for the long term treatment of non life threatening conditions

E2AE2A Clinical Safety Data Management: definitions

and standards for Expedited Reporting

This guide line has been finalized on Oct 1994

It gives standard definitions and terminology for key aspects of clinical safety reporting

It also gives guidance on mechanisms for handling expedited(rapid)reporting of adverse

drug reactions in the investigational phase of drug development

E2BE2B Maintenance of the Clinical

Safety DataManagement including Data Elements for Transmission of Individual

Case Safety Reports

This guideline has been finalized on Feb 2001

E2CE2C Clinical Safety Data Management:

Periodic Safety Update reports for Marketed Drugs

This guide line has been finalized on Nov 1996

It gives guidance on the format and content of safety updates, which need to be provided at

intervals to regulatory authorities after product have been marketed

E2DE2D 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

E2EE2E 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

MULTIDISCIPLINARY GUIDELINES

M

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)

MedDRA Terminology M1

MedDRA Medical Dictionary for Regulatory Activities

MedDRA was approved on 1997 and Terminology was

launched on 1999

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

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

Common Technical Document M4

It was approved on Nov 2000

Data Elements and Standards for Drug Dictionaries M5

It was approved on 2004

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

Genetoxic Impurities M7Assessment 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

ANY QUESTIONS ?

THANK YOU