The EMEA is the European Agency in charge of the evaluation of data submitted by applicants in support of Marketing Authorisations, through the Centralised Procedure. This evaluation is done through its scientific committees in conjunction with experts from the national competent authorities. It is based on the assessment of data on the quality, safety and efficacy of a medicinal product and results in the provision of a scientific opinion to the European Commission on the application for a Marketing Authorisation.

  The Agency does not have the remit of approving clinical trials and is not involved in the collection of genetic information. Therefore, no specific contribution can be made to your questions relevant to the collection of genetic information and generation of DNA profile databases, namely questions 1, 2, 3, 4 and 6.

  However, the EMEA has an interest in the developments in the area of pharmacogenetics and pharmacogenomics, because of the future implications of genetic information in the evaluation of data in relationship to medicinal products. It is recognised that the differences in the genetic make up of patients may explain why there are differences in the benefit/risk ratio among patient populations. Pharmacogenetics aims to unravel the impact of these genetic differences on therapeutic use. It is an area of intense research.

  In June 2000, an information gathering seminar on pharmacogenetics in relationship to medicinal products was held at the EMEA. It looked at the use of pharmacogenetics in the drug development process and the need for common terminology. A copy of the report is attached [not printed].

3 October 2000