EMA Takes Steps To Improve Predictability Of Drug Submissions

25 Jan 2023

The European Medicines Agency says it will become more systematic in seeking explanations from companies who delay or withdraw their planned marketing submissions and in chasing “no-shows.”

LED Display - Airport flight status board (Photo + 3D Rendering) — EMA Has Told Drug Companies That Their Planned Marketing Submissions Will Be Tracked Closely • Source: Shutterstock

The European Medicines Agency has launched an initiative to improve the predictability of new drug applications, given that only around 30-40% of planned marketing authorization applications (MAAs) are submitted for evaluation on time every year, while the rest are either postponed or withdrawn.

While the EMA usually asks companies to provide a rationale when changing their submission dates or withdrawing submissions, the agency...