Rapporteur

Rapporteur is one of the two members of a committee or working party who takes the lead in evaluating an application. The term “rapporteur” is commonly used in the European Union (EU) regulatory framework, particularly within the European Medicines Agency (EMA) and its committees.

When a regulatory application, such as a marketing authorization application for medicine, is submitted for evaluation, it is assigned to a committee or working party composed of experts in relevant scientific and medical fields. This committee or working party is responsible for conducting a thorough assessment of the application and providing recommendations or decisions based on their evaluation.

The role of the rapporteur is to lead and coordinate the evaluation process within the committee or working party. The rapporteur is typically an experienced expert in the specific therapeutic area or scientific discipline relevant to the application under review. They are responsible for organizing and overseeing the evaluation activities, including the review of scientific data, clinical trial results, quality documentation, and other relevant information provided in the application.

The rapporteur works closely with the other committee or working party members, including the co-rapporteur, who shares the responsibility for the evaluation. Together, they assess the application and engage in discussions and deliberations to reach a consensus or recommendation on the outcome of the evaluation.

During the evaluation process, the rapporteur interacts with the applicant, often seeking clarification or additional information regarding the application. They may also engage in discussions with other stakeholders, such as regulatory authorities from other countries or relevant experts, to gather additional perspectives or insights.