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What do you know about ICH E8 (R2) Guidelines


When ICH initiated the guidelines on Clinical studies and Clinical Trials, a set of principles and practices were laid out to ensure that the design and structure of conducting clinical trials.

History of ICH Guidelines.


During the year of the 1960s when the evolution of medicine paved its way to global markets. It was very evident that a detailed evaluation was needed to be conducted on medical products before they were made available on the market.

But one major drawback that was faced is that these evaluations took various times to be delivered and processed differing from countries and regions. As the medical law for this didn't have a proper structure, and the regulations and guidelines for approving the products went under a process of ensuring data, safety, quality and most importantly efficiency of these products made the process very time consuming. Also the need to conduct many test procedures, marketing those internationally was very expensive. 

ICH took place when Europe single handedly took over the market of pharmaceuticals, by which it laid the foundation to rationalize & harmonize  regulations in regards to medical safety, medical cost escalation and minimum delay in making new treatments available for the public. When the topic of ICH was discussed at WHO conference, Drug Regulatory Authorities (ICDRA), in Paris that set of plans needed to be initiated.



In April 1990 the Regulatory Agencies and Medical Industry Association from Japan, Europe and United States gathered at the EPIFA event at Brussels and initiated the ICH guidelines which would harmonize Safety, Quality and the criteria for approving and authorizing new medical products and practices. Later which became a major success in the field of pharma where later the were able to focus on non ICH regions to adapt these set of guidelines that aimed to focus global pharmaceutical regulatory under one place for Harmonisation

What are the ICH guidelines

The ICH after initiating the ICH organization with the aid of Europe,Japan and US certain set of rules were needed to be reverted as per each regional and global procedure, This paved its way to the structuring of ICH guidelines.

These guidelines were set to ensure the safety, effectiveness and high quality of medicine were developed and registered for public use which were accepted globally.

Branches of ICH Guidelines

Quality Guidelines

These set of rules were catered to harmonization in the quality field of medicine, For conducting testings and researches on the stability. Also the approach takes a deep approach being so flexible to quality of GMP (Good Manufacturing Practice) in Pharma and having a risk free approach towards the whole process


Safety Guidelines

ICH  holds a major responsibility in these guidelines as it deals with safety of people, As a result a detailed structured set of guidelines were initiated to eradicate potential risk in pharma like carcinogenicity,genotoxicity and reprotoxicity . which has been a major outbreak in initiating these strategies for Quality testing which deals with liability to drug withdrawals

Efficacy Guidelines

The main motive on these guidelines was to have a methodical process when it comes to Work carried By ICH concerning designs, Conducts and safety on the conducting clinical trials. The various processes of production when it comes to biotechnological processes and techniques in production of better medicine.

Multidisciplinary Guidelines.

These sets of Guidelines were established to include the development of Electronic data standards and transfer regulatory information for ICH medical Terminology. As a result these guidelines have an impact on cross cutting topics which would not fit uniquely into one specific area of work.



Branches of Efficiency Guidelines

Efficiency Guidelines play a major role when it comes to ICH guidelines, where it deals with clinical trials that involve humans and modern day technology involved in productions.

As it is primarily categorized under 20 different segments, which is stated as ICH E1 and goes  ICH  E20, each segmentation plays a major breakthrough in laying the foundation when it comes to efficiency in pharma


ALL About  ICH E8


When ICH initiated the guidelines on Clinical studies and Clinical Trials, a set of principles and practices were laid out to ensure that the design and structure of conducting clinical trials meet the demands of data protection, regulatory authorities and meeting the studies across the product


The main focus on ICH E8 is to give out an detailed structure on clinical Trials which ensure the protection of study subjects, to maintain integrate data and ability to meet the objectives


All You need to know on The ICH E8(R1)


With the modernization towards global medicine and Clinical trials a set of detailed guidelines was established on October 2021 which laid the foundation on conducting clinical trials

As a result of it a detailed step by step process was initiated under ICH on general conduct Clinical trials. Which made a major impact on what basic scientific approach that needs to be catered when it comes to design and conduct, analysis, recognition and the safety of the prospect subject needs to be measured when it comes to the research teams in conducting human clinical trials.



On October 6 2021, ICH took a new step in renovating the ICH E8(R1) Process under 4 steps which was a major breakthrough for Clinical Studies. The main focus was to have a detailed process on effective access to improve the safe and meaningful trials conducted on the patients.

This mainly led to an modernisation in the guideline of ICH E8  of renovation of good Clinical Practice in clinical Trials.


What's New,


The new norms of bringing in technology has brought in a major change to ICH E8 guidelines structure which mainly will be focusing on the QUALITY BY DESIGN. As quality play a vital role when it comes to clinical trials, The new ICH E8(R1) focuses on critical quality factors to protect subjects & to generate reliable data

The legendary strategist Peter Drucker said the “Culture Eats Strategy for Breakfast” where he suggested that to attain Quality by design we should embrace the quality culture that will influence the methods of conducting clinical trials



The fondation which was laid 20 years ago by ICH wich brough in Euprope, Japan, United states and other pharmacetical authorities from diffrent regions to have a strutred way of evaluatinfg and monitoring the standards in technical and scientific aspects of production in regards to pharma



Do you want to understand more about ICH E8 (R1)? Join us at the ICH E8(R1) -US Edition MasterClass on 03rd 04th November, 2022


By Nafhan Naseem, Jr. Social Media Executive & IT Support, GLC Europe, Colombo Office, Sri Lanka. 

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