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EMA’s digital transformation: new Orphan Drug Designation application system


As of June 15th, the European Medicines Agency (EMA) starts the voluntary use of its Scientific and Regulatory Evaluation Procedure Support (S-REPS) for Orphan Drug Designation applications. From September 15th onwards, S-REPS will become mandatory for these applications, replacing the current PDF and Word form-based submission.

Application through S-REPS

S-REPS is a cloud-based end-to-end submission system. It is important to timely arrange for submission through this platform. Companies applying through S-REPS need to establish a User Account and Access Management. They should pre-register themselves through the organisations management services (OMS) in the substance, product, organisation and referential  (SPOR) web-portal. In addition, their substance should be pre-registered via the EU Telematics Controlled Terms (EUTCT) list. Finally, the company needs to request a Research Product Identifier before they can draft and submit applications. To support applicants in this new process, EMA currently develops a guidebook and training videos.

S-REPS extension to PRIME and Business Pipeline Meetings

Although June 15th marks the launch of S-REPS for Orphan Drug Designations applications, EMA acknowledges that this project is the first step in the EMA’s wider digital transformation strategy. Therefore, over time, S-REPS use may be extended to other scientific regulatory processes. The next procedures in line are PRIME and Business Pipeline Meetings.