Substance registration - orphan designation

Dear IRIS-Team, fellow IRIS users,

the company I am working for is considering working towards an orphan designation status. The antibody to be used for the planned treatment is currently registered in SMS and as RPI with a company name (Ab*). We were informed by the RPI team that this name is insufficient for the application of e.g. an orphan designation status. The recommended preferred term of choice for this purpose would be a rINN. We are currently in the process for this but it will take a some time (several months) until publication.

Could we follow the guidance of the "EMA substance names best practice" and post a name we would think is correct in SMS? We would then update with the rINN as soon as this is available. Otherwise, applying for an orphan designation in a reasonable amount of time seems to be unlikely.

I would be glad for some advice and how an orphan designation status can be achieved without a rINN.

Thank you in advance.

Best regards
T. Dirksmeyer

It is indeed possible to apply for orphan designation without a rINN, but the preferred term of the substance involved must be sufficiently descriptive, and as such a company code is not sufficient. Please follow the recommendations of the EMA Substance names best practice document, and proceed to request a modification of the substance name in SMS. This will automatically update the name of your RPI in IRIS, which will allow validation of the submission for orphan designation.