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: From 19 September 2018, sponsors need to use EMA's IRIS system to submit all post-designation activies. 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.

A template for the report is available below, together with a guideline providing advice on the preparation of these reports.

Single report with United States Food and Drug Administration

Sponsors of medicines with orphan designation both in the European Union and the United States (US) can submit a single report using the template below to the EMA and to the US Food and Drug Administration (FDA) at opdar@fda.hhs.gov.

The submission of a single report to the two agencies is voluntary. The two agencies carry out independent reviews and assessments of the report's contents.

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