Duration of Time Intervals for Risk Minimization Measure Effectiveness Studies

Area of Science:

• Pharmacovigilance and Drug Safety
• Regulatory Science
• Pharmaceutical Policy

Background:

• Regulatory oversight of medicines requires robust evaluation of risk minimization measures (RMMs) effectiveness.
• Post-authorization safety studies (PASSs) are crucial for assessing RMMs in real-world settings.
• Understanding the timelines for RMM effectiveness studies can identify bottlenecks in the regulatory process.

Purpose of the Study:

• To assess the time intervals between key regulatory milestones for RMM effectiveness studies.
• To identify the most time-consuming phases in the evaluation of RMM effectiveness PASSs.
• To provide insights for optimizing the RMM effectiveness assessment process.

Main Methods:

• Retrospective analysis of completed RMM effectiveness PASSs assessed by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) between 2016 and 2022.
• Extraction of regulatory document dates from EMA databases.
• Calculation of time durations between study request, protocol assessment, study start, and final study report assessment.

Main Results:

• The median duration from study request to final PRAC outcome for RMM effectiveness PASSs was 52 months (over 4 years).
• The period from study request to study start averaged 21 months, representing a significant time lag.
• Protocol assessment for studies with approved protocols took a median of 7 months.

Conclusions:

• The overall timeline for evaluating RMM effectiveness PASSs significantly exceeds four years.
• The pre-study phase (request to study start) is a major contributor to the extended duration.
• Improving guidance and encouraging timely protocol submissions could expedite the evaluation of RMM effectiveness.