A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU

Abstract

The aim of this study was to assess the effect of expedited regulatory approval programs used by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), type of product (small molecule or biotechnology-derived product) and consulting scientific advisory committees on the regulatory review time of the marketing authorization applications (MAAs) for new anticancer drugs. A dataset composed of 76 new anticancer drugs was constructed. The date of submission of the MAAs in the United States and the European Union were comparable. The typical review time of MAAs was 136 days shorter in the United States (201 days [median]) than in the European Union (337 days [median]). The type of product did not have a high impact on the review time. The review time of the MAAs for drugs undergoing priority review in the United States or accelerated assessment in the European Union at the stage of review of MAA was generally shorter than that for drugs following the standard regulatory pathway. The regulatory pathway using at least one expedited regulatory program at the stages of drug development, review of MAA, and approval of drug in the United States (172 days [median]), and that at the stages of review of MAA and approval of drug in the European Union (183 days [median]) enabled the shortest review time of MAAs. Referral to advisory committee meeting increased the review time of MAAs for drugs undergoing one or more expedited regulatory approval programs in the United States and the European Union close to that for drugs undergoing the standard regulatory approval pathway.

FIGURE 1

Review time of MAA for new anticancer drugs (small molecules and biotechnology‐derived products) by the FDA and the EMA. Data are presented as median ± standard error of the median (SE). Small molecules (n = 49) and biotechnology‐derived products (n = 27). EMA, European Medicines Agency; FDA, US Food and Drug Administration; MAA, marketing authorization application.

FIGURE 2

Review time of MAA for new anticancer drugs by the FDA and EMA following different regulatory pathways. (a) Review time by the FDA. (b) Review time by the EMA. (c) Review time by the FDA and the EMA undergoing at least one expedited regulatory program and advisory committee meetings. Data are presented as median ± SE. EMA, European Medicines Agency; FDA, US Food and Drug Administration; IC‐SAG, Inter‐Committee Scientific Advisory Group on Oncology; MAA, marketing authorization application; ODAC, Oncologic Drugs Advisory Committee.