History

History

The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing ICH as an international association, a legal entity under Swiss law.

This step built upon a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development as well as their regulation, and a longer standing recognition of the need to harmonise.

The Need to Harmonise

The realisation that it was important to have an independent evaluation of medicinal products before they were allowed on the market was reached at different times in different regions.

However in many cases the realisation was driven by tragedies, such as that with thalidomide in Europe in the 1960s.

For most countries the 1960s and 1970s saw a rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal products.

Industry found it necessary to duplicate many time-consuming and expensive test procedures in order to market new products internationally.

The urgent need to rationalise and harmonise regulation was impelled by concerns over rising costs of health care and the need to meet public expectations.

Initiation of ICH

Harmonisation of regulatory requirements was pioneered by the EC in Europe in the 1980s.

There were discussions between Europe, Japan and the US on possibilities for harmonisation.

At the WHO Conference of Drug Regulatory Authorities (ICDRA) in Paris in 1989 specific plans for action began to materialise.

Soon afterwards authorities approached IFPMA to discuss a joint regulator-industry initiative and ICH was conceived.

The birth of ICH took place at a meeting in April 1990 hosted by EFPIA in Brussels.

Topics selected for harmonisation were divided into Safety, Quality and Efficacy.

The Evolution of ICH

Since ICH’s inception in 1990 the process has gradually evolved.

ICH’s first decade saw progress in Safety, Quality and Efficacy guidelines.

Important multidisciplinary topics included MedDRA and the CTD.

Communication of guidelines with non-ICH regions became a key focus.

Now in its fourth decade ICH is extending harmonisation globally.

A major step in 2015 introduced organisational reforms and established ICH as a legal entity.

The ICH Assembly now serves as the governing body for global harmonisation work.