Authorisation and Withdrawal of Pharmaceutical Innovations in the European Union and in the United States (1995-2003)

Abstract

This is a comparative study of the average and median approval times for pharmaceutical innovations (new molecular entities -NMES- and new biologics), authorised in the United States (US) and in the European Union (EU) under the centralised procedure, during the period 1995 to 2003. Marketing withdrawals for safety reasons have been monitored, since in both cases the objective is to obtain faster reviews without compromising safety. A total of 346 innovations were authorised during this period in the US (274 NMEs and 72 new biologics) and 169 in the EU. On average for the period under study, the mean approval time for these innovations was 14.7 months in the EU versus 18.2 months in the US (16.2 months if new biologics are excluded). Similar results were obtained from the comparison of median approval times. Nevertheless, in both cases, the approval time for priority NMEs authorised by the FDA was markedly shorter. Despite the differences between both approval procedures, the percentages of withdrawals were very similar: 2.2 % in the US and between 1.6 % and 2.7 % in the EU, depending on the approach used for calculations. Finally, a comparison was also made of approval times of the 117 innovations that were authorised simultaneously in both the US and in the EU during the period under study. The results obtained in this regard differ from the previously stated ones. Although the mean approval time for standard innovations continues to be shorter in the EU, the mean approval time for pharmaceutical innovations as a whole is now shorter in the US (12.5 months versus 14.3 months in the EU). The explanation can be found in the predominance of priority NMEs included in the set of innovations approved for both markets. This outcome reveals one of the main differences between both authorisation procedures: unlike the US, the EU has not established a fast-track review system for therapeutically relevant drugs.