October 2021: EU Update-Good Lay Summary Practice Guidance

European Commission uploaded Good Lay Summary Practice Guidance documentĀ on October 04, 2021:

According to the Regulation (EU) No. 536/2014, Article 371 “EU CTR”, submission of lay summary that is understandable to lay persons is mandatory for each and every pharmaceutical clinical trial that goes into EU database.

This guidance document proffers detailed recommendations for pre-eminent practices of planning, preparation, translation, and dissemination of high-quality lay language summaries of clinical trial results with medicinal products. It is divided into two parts, Part 1-GLSP Quick Guide and Part 2-GLSP handbook, respectively. The GLSP Quick Guide provides an abstract that contains the key aspects of the recommendations provided in the Handbook.

For more information, please click here.