An incompressible 90-day period for scientific evaluation: a minimum guarantee of safety

Contrary to claims from some pharmaceutical industry representatives, the maximum 210-day period allotted for marketing authorisation decisions is necessary to avoid risky fast tracking. However, in exceptional circumstances it is acceptable to shorten this period to 150 days (accelerated procedure) for very promising drugs designed for patients who have no alternative.

In order to guarantee strict and thorough scientific evaluation, and to offer patients minimum safety guarantees, the rapporteur and co-rapporteur must be provided in all cases with an incompressible 90-day period in which to conduct their evaluation. This period, devoted to the analysis of pharmacological, toxicological and clinical data, must be guaranteed, even if the work can be completed more rapidly in some cases. In contrast, the time allotted for administrative procedures may be shortened.

In its analysis of the EU Parliament's vote, the Commission considers that this notion of an incompressible 90-day period is a simple "detail" that can be dealt with through internal procedures. The Medicines in Europe Forum maintains that scientific evaluation of new drugs is not a "detail", and that the time necessary for this work must be laid out in the Regulation.

The need for a 90-day period should be inserted at the end of the first sentence of article 6-3 and at the end of the third sentence of article 13-6.

©La revue Prescrire for the Medicines in Europe Forum 1 March 2003