By TEJASWINI 4th Year B.

Pharmacy

 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.

 ICH

guidelines and topics

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

ICH TOPICS
QUALITY (Q) SAFETY (S) EFFICACY (E) MULTI DISCIPLINARY (M)

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

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

This guide line has been finalised on4th july, 1997

This guide line has been finalised on march, 2008

EFFICACY GUIDELINES

This guide line has been finalized on 4th Oct 1994

This guide line has been finalized on Oct 1994

This guide line has been finalized on Nov 1996

E2D 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

E2E 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

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 Virus and Gene therapy vector shedding and Transmission It was approved on 2009

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 M7
Assessment 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