The European Medical Association (EMA) will launch a new system for orphan drugs on 15 June 2018. The portal will be a single point of information and support for applications to qualify as an orphan drug, to all the advice and documents needed post-designation.
Scientific and Regulatory Evaluation Procedure Support (S-REPS) will come into effect on 15 June, but the EMA will continue to allow applications by the previous system until 15 September 2018. MAP have been told, “the new business process will mandate the use of Organisations Management System (OMS) data as part of the overarching substance, product, organisation and referential (SPOR) master data programme“.
The EMA say:
This change is part of an EMA-wide programme to improve the way it records and manages master data and interacts with external stakeholders. The benefits of the new portal will be:
- a single platform to submit and access all orphan designation data and documents;
- better data quality;
- faster, simpler access to the right information.
It will require a little initial time investment to register as a portal user, but once registered it will be quicker and easier to complete an application and to view its status or receive automatic status updates.
The portal will also work on mobile devices.
To ensure a smooth transition, EMA is working with a group of volunteers from twenty-six organisations to provide feedback on the user interface and guidance and take part in user acceptance testing.
Click here to read the EMA’s advice on the incoming system.