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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