EU: Improved way to apply for and manage orphan designations


EU: Improved way to apply for and manage orphan designations

(Source: EMA 2018-06-19)

On 19 June 2018, EMA will launch a new secure online portal for sponsors to submit applications for orphan designation and to manage post-designation activities.

EMA strongly encourages sponsors to start using the new portal from 19 June onwards, although it will continue to accept applications via existing processes until 19 September 2018.

On 19 June, EMA will provide a link and simple guidance on how to use the portal. In the meantime, sponsors do not need to take any action.

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.

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