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ICH (International Conference on Harmonisation) and its Guidelines:

Clinical Research

ICH (International Conference on Harmonisation) and its Guidelines:

We are quite known to the term ICH-GCP and most of us have an understanding that GCP (Good Clinical Practice) are guidelines that have been proposed by ICH for the Clinical Research arena. Let us now focus on the organisation of ICH, which very few of us have tried to explore.

As we all know that all the guidelines came into existence after realizations that were tragedy driven (for example the Thalidomide Tragedy that occurred in Europe in 1960). During 1960-1980, there was urgent need to rationalize and harmonize regulations, which was overshadowed by multiple concerns like over rising costs of health care with the public demands to have safe and effective drugs in the market in the shortest possible time.

The success was achieved after Europe demonstrated the possibility of a feasible harmonisation. The mutual discussion between Europe, Japan and the US on possibilities for harmonisation resulted in initiation of ICH after the WHO Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989.

Soon after specific plans for action began to materialize and in 1990 in a meeting, hosted by EFPIA in at Brussels, birth of ICH took place. Representatives of member states (EU, US & Japan) along with the regulatory agencies and industry associations met to plan an International Conference. They also discussed about the wider implications and terms of reference of ICH.

Two decades later, the ICH process has gained much success which is attributed not only to a process of scientific community widely represented by industry and regulatory experts, but also to the commitment of the regulatory authorities to implement the ICH Tripartite Harmonised Guidelines with its recommendations.

ICH has proposed guidelines in four areas. Those are Quality, Safety, Efficacy & Multidisciplinary Guidelines. The much famous ICH – GCP guidelines are nothing but the 6th part of Efficacy Guidelines.

Quality Guidelines:
These focus mainly on Quality area, which includes; conduct of stability studies and a flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Safety Guidelines:
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity.

Efficacy Guidelines:
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. (E6: ICH – GCP Guidelines)

Multidisciplinary Guidelines:
Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

1) ICH – International Conference on Harmonisation (2012), Jan 17th 2012,

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