OBJECTIVES: The implementation act adopted for HTA regulation defined the timelines of scoping, submission and assessment and output of Joint Clinical Assessment (JCA), which will be in parallel with the European Medicines Agency (EMA) timelines. This study aims to understand the variation on company response times and the potential influence from JCA dossier submission, by analyzing the breakdown of the current EMA review cycle time, frequency and variation of clock-stops in the approval process of oncology new active substances (NASs)

METHODS: Data was extracted from EMA reports from oncology NASs approved between 01-Jan-2019 to 31-Dec-2023. Review time is calculated by start of scientific assessment to the outcome letter, clock-stop time was calculated as the timing between the release of outcome letters and the response from sponsors from oncology NASs approved for each cycle of communication.

RESULTS: The first and second clock-stop occurred in 100% (n=83) of the oncology products approved, while only in 11% of these products more than 2 clock-stops were needed. The time for the first scientific assessment for standard reviews showed median of 119 days and a median of 89 days for accelerated reviews. The first clock-stop had a median duration of 77 days, with a variation ranging from 50 days (25th percentile) to 97 days (75th percentile), followed by the second scientific assessment (median 63 days).

CONCLUSIONS: Our analysis showed that all oncology products utilized both the first and second clock-stops, with additional clock-stops being rare. The JCA submission is due 100 days after the initial JCA sub-group request, which follows the JCA scoping expected 10 days post first scientific assessment. Consequently, JCA submission may coincide with or follow the first clock-stop phase. Preparing for JCA might affect the company's response time to EMA queries. This study offers a baseline to assess changes in the regulatory review process post-HTAR implementation.