What Can be Learned from Experience Gained using the Old European Concertation Procedure?

The feasibility of collecting detailed information on the marketing authorization of new medicines in the European Union was investigated by conducting a study to obtain data on the use of the concertation procedure. Ten pharmaceutical companies provided information on 13 biotechnology or high technology products going through the procedure between 1988 and 1993. The main reason for choosing the rapporteur state was for its experience. Discussions with the rapporteur were considered useful, particularly for guidance, facilitating timely responses to questions and forestalling divergence of opinion. The total length of time of the procedure ranged from 272-882 days. The length of time to national marketing authorization following a favorable Committee for Proprietary Medicinal Products (CPMP) opinion ranged from 5-1,374 days. The rapporteur authority tended overall to be the quickest, and conversely, authorities dissenting in the original CPMP opinion were among the slowest to grant national authorization. In general, good harmonization of the summary of product characteristics was achieved. This study provides companies with useful information on the concertation procedure and will also be helpful for designing future studies of the newly established centralized and mutual recognition procedures.