OBJECTIVES: The aim of this study was to estimate the time taken by the European Medicines Agency (EMA) centralized evaluation procedure of drug approval applications.

METHODS: A literature review of medicinal products that began the initial authorization procedure between 2015 and 2017 was performed using InnMediata, a secondary database that contains the registration and follow-up of all centralized marketing authorizations for human drugs evaluated by the EMA. Withdrawn and post-authorization applications were excluded. Non-orphan, orphan, biosimilar and antineoplastic medicines were analyzed. The median time between submission of the marketing authorization application (MAA) and the EMA Committee for Medicinal Products for Human Use (CHMP) scientific opinion was estimated for the standard and accelerated procedures.

RESULTS: At the time of analysis, 70% of the medicinal products had received a positive or negative opinion, while 30% remain under assessment. The results shown below are focused on MAAs with an opinion, of which 55% were non-orphan, 27% orphan and 18% biosimilar medicines, while nearly 30% were for antineoplastic medicines and around 10% followed the accelerated procedure. The median time from the beginning of the procedure to the CHMP opinion was 337 days (range: 59-807) and 189 days (147-420) for the standard and accelerated procedures, respectively. An evaluation time of < 210 days for standard applications and < 150 days for accelerated applications was achieved in 10% and 5% of applications, respectively. The median clock-stop time ranged from 125 to 190 days for the standard procedure and 30 to 40 days for the accelerated procedure, depending on the category of the drug analyzed.

CONCLUSIONS: Approximately 50% of applications evaluated were orphan or biosimilar drugs, for which a longer clock-stop time was observed compared with non-orphan original drugs in both the standard and accelerated procedures.