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Contact us- Clinical trials are the most complex, costly and time consuming aspect of any drug development program.
- Repeat clinical trials have been necessary if a company wishes to market a drug in more than one country.
- A recent survey by the International Conference on Harmonisation (ICH) shows a common set of guidelines has reduced research duplication.
Position
During the past biennium, the IFPMA Secretariat was consulted on more than fifty scientific, regulatory and health policy issues. It is also anticipated that IFPMA will continue to be asked to provide experts to participate in a large number of WHO consultations ranging from broad policy issues to highly specialized topics. During the last biennium, over 120 such requests were received and IFPMA nominated industry experts for most of the invitations received.
The collection of comments on WHO consultative documents and the process of nomination of industry experts provide a substantial workload. Members of IFPMA can provide important guidance on this activity, which is technical but loaded with significant policy implications in some cases and sometimes IFPMA must field the expertise as companies are not permitted to participate.
The International Conference on Harmonisation (ICH)
Central to any discussions on regulatory harmonization is the work of the International Conference on Harmonisation (ICH) with which IFPMA has been closely associated from the start (1990) by providing the ICH Secretariat.
The industry partners in ICH strongly support these harmonization efforts and IFPMA will continue to provide the ICH Secretariat whose activities are funded by the three industry ICH parties (EFPIA, JPMA and PhRMA) and by surplus coming from the ICH Conferences. The ICH Secretariat's role is primarily to provide technical and administrative support for the ICH Steering Committee (2-3 meetings a year), ICH Expert Working Groups (2-3 meetings a year), and the MedDRA Management Board (3-6 meetings a year). IFPMA is also involved in the organization of the program and documentation for the major ICH Conferences now held every three years (ICH6 took place in Osaka, Japan, in November 2003).
Today, companies invest in global clinical development programs involving the development and testing of medicines in the emerging newly industrialising countries. The globalisation of the R&D industry poses a particular challenge and we need to find ways to avoid duplication of testing and reporting by ensuring that the benefits of harmonisation extend beyond the three-region boundaries of the US, EU and Japan.