Submitting annual reports on medicine development
This page provides information on the report that sponsors must submit to the European Medicines Agency (EMA) every year after their medicine receives an orphan designation, until they submit an application for marketing authorisation.
Update: Simplification on annual reports - sponsors are not requested to submit any documents; it is sufficient to complete the requested fields in the IRIS system. Optionally, additional documents can still be uploaded if appropriate.
Sponsors need to use EMA's IRIS system to submit all post-designation activities, including annual reports. EMA will not be able to process any submissions outside of IRIS. For information and guidance on using IRIS, please see Applying for orphan designation.
If a sponsor subsequently withdraws a marketing authorisation application, or the application receives a negative opinion from the Committee for Medicinal Products for Human Use (CHMP), they need to resume submitting annual reports on development.
These annual reports on development provide information on the status of the development of the medicine, including:
- a review of ongoing clinical studies;
- a description of the investigation plan for the coming year;
- any anticipated or current problems in the process, difficulties in testing and potential changes that may have an impact on the medicine's orphan designation.
If the sponsor wishes to inform about Changing the name or address of a sponsor or Transferring an orphan designation, this should not be done in the annual report. For this purpose it is necessary to undergo the procedure outlined in section G of the Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designation form one sponsor to another(ENTR/6283/00).