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Orphan drug

New IRIS portal will be mandatory for Orphan Drug Designations process

EMA expects the portal to reduce the time needed to prepare and submit applications

EMA expects the portal to reduce the time needed to prepare and submit applications
July 11, 2018
On 19 June 2018, EMA launched a new secure online portal through which orphan designation for a medicine can be applied to the European Medicines Agency (EMA).
The portal is called IRIS and as of 19 September will be the mandatory submission process for Orphan Drug Designations (ODD) applications. It can be used to manage all important ODD activities including the submission of applications for orphan designation and the management of post-designation activities. Users can check the status of their applications from any device and receive automatic notifications when the status changes.
EMA has shared a “Sponsor’s guide to an orphan drug designation” with the flowchart for the ODD process. You can download it here:
All details about ODDs and the new portal can be found on the EMA website expounded in three main guidances:
Of particular note, the IRIS portal will already be using some elements of EMA’s Master Data concept. Master Data concept is based on the ISO IDMP standard (Identification of Medicinal Products) and that a key part are the SPOR services. As stated in the guideline “IRIS Quick guide to registration”, the new IRIS portal for ODDs will already make use of parts of SPOR, namely Organisations (e.g. the pharmaceutical company) and the Substances master data.
If you are planning to apply for an EMA ODD and you need support with IRIS portal, do not hesitate to contact us. Asphalion has wide experience in ODD applications, with +20 ODD, and can support you throughout all the process: dossier preparation, pre-submission meeting, submission of the application via IRIS portal, support for the list of issues responses, meeting attendance, and  post-designation activities through IRIS.
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