PMU66 TIMEFRAME FOR DRUG MARKETING AUTHORIZATION IN EUROPE

Abstract

The aim of this study was to compare expected vs observed times of drug marketing authorization [MA] by European Commission [EC] for the European Medicines Agency [EMA] centralized evaluation procedure. A literature review was performed using INMEDIATA, a secondary database that contains the registration and follow-up of all centralized marketing authorization applications [MAAs] for human drugs evaluated by the EMA. All drugs that began the evaluation procedure between January 2015 and April 2019 were included for the analysis, except generics and hybrids. For authorized drugs, the median time between submission of the MAA and the EC MA was calculated, depending on standard and accelerated evaluation procedures by the EMA. The expected theoretical duration of MA was considered without clock-stop time, specifically 277 days for standard evaluations and 217 for accelerated procedures. For all MAAs, the European regulatory status was described. In the study 601 MAAs were included. At the time of analysis, 394 (65.6%) were authorized, 58 (9.7%) were withdrawn, 13 (2.2%) were refused and in 136 (22.6%) the decision was still pending. Of all MAAs, 331 (55.1%) were new innovative medicines, 270 (44.9%) extensions of indication, 137 (22.8%) orphan drugs, 59 biosimilar medicines (9.8%), 9 (1.5%) advanced therapy medicinal products and 194 (32.3%) were anti-cancer medicines. For authorized drugs, the median (range) duration for MA was 325 (85-999) days and 224 (91-515) days for the standard and accelerated procedures, respectively. More than 60.9% MA decisions exceeded the expected theoretical duration of the European regulatory assessment. The deviation of expected vs median observed MA time was 48 days for standard procedures and 7 days for accelerated evaluations. Median durations of EC MAs exceeded the theoretical timelines, especially for drugs undergoing the standard procedures with an overall deviation of 48 days.