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The Fourth International Conference on Harmonisation, ICH 4, held at the Brussels International Conference 16-18 July 1997, was attended by over 1,600 participants.  The Plenary Programme for the Conference included discussions on the Research Issues, the Impact and Use of the ICH Guidelines, the Benefits of Harmonisation and the Way Forward.

In five Parallel Technical Workshops, the experts from the pharmaceutical industry and regulatory agencies in the three ICH regions discussed the integration of the ICH Guidelines, with pre-existing guidelines, into the drug development and registration process.  These five Workshops addressed: Quality Assurance, the special requirements for Biotechnological Products, Non-clinical Safety Testing, Clinical Studies and the on-going Safety Monitoring and Information Exchange that continues throughout the life of a medicinal product.

Participants at the Conference were mainly from pharmaceutical industry and regulatory agencies from Europe, Japan and the USA, but also including a large number of countries outside the ICH regions.

New Guidelines and Recommendations

The ICH Steering Committee met on 15 and 16 July 1997, and Expert Working Groups were also in Session, earlier in the week, with a result that many of the last remaining guidelines were finalised by the time the Conference began.  A total of ten guidelines, which had been released for regulatory consultation over the last year were finalised and adopted as ICH tripartite harmonised guidelines.  Consensus was reached on the final two of the guidelines which were at the consensus building stage and these were released for regulatory consultation.  Details are given below and ICH Topics has a full listing of ICH Guidelines and their Status.

In addition, the Steering Committee announced the publication of Version 2.0 of the Medical Dictionary for Regulatory Activities which will provide a common terminology which will facilitate communications, particularly on safety issues.

Progress on Guidelines at ICH 4

Step 4: Finalised Guidelines

Step 2: Guidelines Released for Consultation

Common Technical Document

Another important announcement from the Steering Committee was agreement that work should commence on harmonising the format and content of the application documents for new product applications.

This is seen as the next logical step having achieved agreement on technical guidelines for generating the data.

Expert Working Groups will be set up to review the Quality, Safety and Efficacy sections of the application.  In view of the nature of the Topics the composition of the Working Groups will be extended.  In addition to members from the six ICH Parties, the Observers to ICH and representatives of the generics industry and the manufacturers of products for self-medication have been invited to nominate Experts to the relevant Groups in which they have a specific interest.  These Groups will meet for the first time in January 1998, prior to the next meeting of the ICH Steering Committee.

It has been estimated that it will take about two years, from that time, to achieve the objective of reaching consensus on a Common Technical Document for submitting applications, in all regions.

See ICH Topics for a full listing of ICH Guidelines and their Status.

Copyright© 1998 International Federation of Pharmaceutical Manufacturers Associations