Deadlines for Submission of Applications for Orphan Medicinal Product Designation to the EMA

The European Medicines Agency (EMA) has outlined critical deadlines for submitting applications for orphan medicinal product designation. This designation is essential for medicines intended to diagnose, prevent, or treat conditions that affect fewer than 5 in 10,000 individuals in the European Union (EU). The purpose of the orphan designation is to encourage the development of treatments for rare diseases, thus providing incentives such as reduced fees and market exclusivity.

COMP Timetable for Valid Applications (2024-2025)

As part of the regulatory framework, the Committee for Orphan Medicinal Products (COMP) has established a timetable for evaluating valid applications. The following is the deadline schedule for submitting requests during the years 2024 and 2025:

• Submission Deadline: January 31, 2024 – COMP Meeting: March 2024
• Submission Deadline: April 30, 2024 – COMP Meeting: June 2024
• Submission Deadline: July 31, 2024 – COMP Meeting: September 2024
• Submission Deadline: October 31, 2024 – COMP Meeting: December 2024
• Submission Deadline: January 31, 2025 – COMP Meeting: March 2025
• Submission Deadline: April 30, 2025 – COMP Meeting: June 2025
• Submission Deadline: July 31, 2025 – COMP Meeting: September 2025
• Submission Deadline: October 31, 2025 – COMP Meeting: December 2025

These deadlines are crucial for stakeholders engaged in developing orphan drugs, as timely submission can lead to faster access to the incentives provided by the orphan designation status. Organizations are encouraged to prepare their applications well in advance to ensure that they meet these critical timelines.

Conclusion

Adhering to the submission deadlines and understanding the corresponding COMP meeting schedules is vital for the advancement of therapies aimed at treating rare diseases. For those involved in this sector, being aware of these dates can significantly impact the success of their projects.