The Need to Harmonise

The realisation that it was important to have an independent evaluation of medicinal products before they are 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, whether or not they had initiated product registration controls earlier, 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. The industry, at the time, was becoming more international and seeking new global markets, however the divergence in technical requirements from country to country was such that 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, escalation of the cost of R&D and the need to meet the public expectation that there should be a minimum of delay in making safe and efficacious new treatments available to patients in need.

Initiation of ICH

Harmonisation of regulatory requirements was pioneered by the European Community (EC), in the 1980s, as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonisation was feasible. At the same time there were bilateral discussions between Europe, Japan and the US on possibilities for harmonisation. It was, however, at the WHO Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989, that specific plans for action began to materialise. Soon afterwards, the authorities approached IFPMA to discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived.

The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH.

At the first ICH Steering Committee (SC) meeting of ICH the Terms of Reference were agreed and it was decided that the Topics selected for harmonisation would be divided into Safety, Quality and Efficacy to reflect the three criteria which are the basis for approving and authorising new medicinal products.

The Evolution of ICH

For two decades the ICH process has achieved much success. This success is attributed not only to a process of scientific consensus developed between industry and regulatory experts, but also to the commitment of the regulatory parties to implement the ICH Tripartite Harmonised Guidelines and recommendations.

Since ICH's inception in 1990, the ICH process has gradually evolved. ICH's first decade saw significant progress in the development of Tripartite ICH Guidelines on Safety, Quality and Efficacy topics. Work was also undertaken on a number of important multidisciplinary topics, which included MedDRA (Medical Dictionary for Regulatory Activities) and the CTD (Common Technical Document). As ICH started into a new millennium, the need to expand communication and dissemination of information on ICH Guidelines with non-ICH regions became a key focus. Attention was also directed towards facilitating the implementation of ICH Guidelines in ICH's own regions.

Throughout the second decade the development of ICH Guidelines continued, but with more attention given to the need to maintain already existing Guidelines as science and technology continued to evolve. The need to leverage with other organisations was also acknowledged, particularly for the development of electronic standards. The SC recognised the benefits afforded by collaboration with Standards Development Organisations, not only from the perspective of having a larger available pool of technical expertise, but also the opportunity to progress ICH standards as global standards.

Entering into its third decade of activity, ICH's attention is directed towards extending the benefits of harmonisation beyond the ICH regions. Training, as well as active participation of non-ICH regions in guideline development, are seen as key in this effort.

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"If everyone is moving forward together, then success takes care of itself."

Henry Ford