The European Medicines Agency (EMA) this week issued a question-and-answer guidance to address sponsors’ questions on its pilot testing the review of raw clinical trial data for marketing authorization applications (MAAs) and post-authorization applications.
EMA issued an updated guidance on the pilot in October. (RELATED: EMA to explore reviewing raw data from clinical trials in applications, Regulatory Focus 12 July 2022)
The purpose of the pilot is to “investigate the benefits of having access to raw data from regulatory submissions to support the scientific assessment of medicinal products and to identify the associated operational, resource and technological needs.”
The guidance addresses general questions, terms for participating, the data package to be submitted and technical questions related to submitting the raw data.
Examples of raw data include records of original observations and measurements of clinical study participants, including clinical laboratory results, imaging data and patient medical charts…
