International cooperation between regulatory bodies for the conformance of regulatory requirements is key to support the effective development of medicines and ensuring sufficient safety oversight. ICH E2B R3 format poses an opportunity to gain greater insights into case reports and the benefit-risk profile of medicines due to the improved granularity of the data and thereby the quality of ICSRs. The revision, however, also introduces the industry to technical challenges requiring detailed preparation and lengthy planning to maintain regulatory compliance, as increasing countries come onboard. Other regions will need to follow suit.
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It is an international Standards Development Organisation SDO that exists to promote the harmonisation of requirements for the registration and and on-going regulation of pharmaceuticals across the major global regions EU Japan and USA.
ICH brings together regulators and Industry professionals from the global regions to participate in scientific debate on pharmacovigilance methodologies and procedures to be used to monitor and ensure the safety, quality and efficacy of medicines intended to treat humans.
The rationale behind its formation was the growing understanding within scientific communities that the goals of pharmacovigilance services would be better met if there existed a greater degree of uniformity regarding testing and safety regulations across the different regions. Below are the ICH guidelines for pharmacovigilance: E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions Description: This document gives recommendations on the numbers of patients and duration of exposure for the safety evaluation of drugs intended for the long-term treatment of non-life-threatening conditions.
It also gives guidance on mechanisms for handling expedited rapid reporting of adverse drug reactions in the investigational phase of drug development. The ICH Steering Committee had taken a key decision that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations SDOs to enable wider inter-operability across the regulatory and healthcare communities.
Following minor editorial updates an updated version of the IG was published in July Minor updates were made in some documents included in the IG package in November v1. Download Link: Click here E2C R2 : Periodic Benefit-Risk Evaluation Report Description: This document gives guidance on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed.
The Guideline is intended to ensure that the worldwide safety experience is provided to authorities at defined times after marketing with maximum efficiency and avoiding duplication of effort. Download Link: Click here E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting Description: This document provides a standardised procedure for post-approval safety data management including expedited reporting to relevant authority.
The definitions of the terms and concept specific to post-approval phase are also provided. E2A definitions in clinical safety data management was maintained in this document as post-approval safety data management, such as seriousness definition.
The practices of the data management were standardised in such cases obtained from consumers, literatures, internets which are all specific to post-approval data management. Good case management practice was focused and recommended for expedited reporting with clear definitions. Download Link: Click here E2E: Pharmacovigilance Planning Description: This Guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug in this Guideline, the term "drug" denotes chemical entities, biotechnology-derived products, and vaccines.
The main focus of this Guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of licence application. Download Link: Click here E2F: Development Safety Update Report Description: The main focus of the DSUR is data from interventional clinical trials referred to in this document as "clinical trials" of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors.
It should be noted that these documents are only examples and therefore did not go through the formal ICH Step Process. Download Link: Click here These documents provide a high degree of detail about the expected manner, method, timing, frequency and circumstances in which pharmaceutical companies and other relevant parties need to report suspected adverse reactions and other vital clinical data to the regulatory authorities.
As well as the clinical safety guidelines above, the ICH also focuses on other distinct areas. It has contributed a tremendous volume of guidelines for medicinal product Efficacy, and Quality. These include the widely used M1 guideline, which in fact is the MedDRA medical terminology Medical Dictionary for Regulatory Activities and the M2 guideline, which specifies the technical framework used for the electronic transmission of safety information, as well as guidelines setting standards for other key elements of pharmaceutical regulatory activities, such as data elements for drugs dictionaries and the Common Technical Document comprising the registration dossier for new medicines.
U.S. Food and Drug Administration
Clinical Safety Data Management - ICH E2B (R3)