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Role of regulatory agencies in translating pharmacogenetics to the clinics.

Overall, the regulators (here the term is used in the broad sense including competent authorities, the national departments of health and the European commission) have a significant role in translating pharmacogenomics into clinical practice. The first objective is to establish the role of the genomic information that is available, and this should be data driven. Conduct of robust clinical trials that are sound both scientifically and from a regulatory perspective should be encouraged. Significant interaction between Academia, Pharma industry and the regulator is essential with the overall aim of improving public health. Conceptually, this would involve the triumvirate (Academia, industry and regulators) as an orchestra with the regulators perhaps taking the role of the conductor while the significant players would be those that generate data (Academia and industry). The regulators also need to ensure that clear guidance is available for use of the information and the tests with a significant level of uniformity between the ICH regions. The commercial availability of the test will have considerable impact on the use of pharmacogenomics, but this is currently beyond the scope of this paper.