EMA to open secure portal for orphan drug designations

The European Medicines Agency (EMA) is launching an online portal for orphan drug designations. The EMA wants sponsors to start using the portal from 19th June 2018, in anticipation of it becoming mandatory in three months’ time.

Once the portal is live, it will provide sponsors with a new way to file for orphan drug status and manage their existing designations. The EMA hopes that creating a single platform for the submission of, and access to, orphan drug designation data and documents will result in easier access to information and improve data quality. Also, sponsors will receive automatic status updates.

After sponsors have reviewed a guidance document, which will be released next week, the EMA hopes that sponsors will be able to navigate the system. However, sponsors will first need to register as portal users.

Sponsors can continue to apply for orphan drug designations via the existing processes, as the EMA phases in the use of the portal over the next three months. To help ensure that the portal is ready for the September transition, the EMA is collecting feedback from 26 organisations through a user acceptance testing program.

The EMA stated that the portal is part of an EMA-wide program to improve its interaction with the industry and management of master data, the reusable, non-transactional information that is key to the operation of business.

To read more about the online portal, and how to apply for orphan designation, please click here.