RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2020 > 10 > EMA moves to IRIS for scientific advice questions

EMA moves to IRIS for scientific advice questions

Posted 07 October 2020 | By Kari Oakes 

EMA moves to IRIS for scientific advice questions

The European Medicines Agency (EMA) is transitioning to an online platform for drug developers to use when requesting scientific advice. The change will become effective on 19 October for developers of both human and veterinary medicinal products.
The regulatory and scientific information management platform, known as IRIS, “aims to make the handling of product-related regulatory procedures more efficient and user-friendly and to ensure better data quality through integration with other EMA systems,” including EMA’s substance, product, organization and referential (SPOR) portal, said EMA.
Applicants, who must first register to use IRIS, may then submit requests, documentation and other information to EMA, as well as conducting other communications pertaining to scientific advice procedures.
For human medicine developers, the procedures that are transitioning to IRIS access include initial and followup inquiries regarding scientific advice, protocol assistance and qualification procedures.
EMA’s shift to the IRIS platform for developers seeking scientific advice is part of the agency’s larger digital transformation movement. The platform was launched in mid-2018. Currently, the platform is used to apply for orphan designation, for notification of parallel distribution, to apply for briefing meetings with EMA’s Innovation Task Force, and to request Research Product Identifiers for new medicinal products. (RELATED: EMA expands online portal for parallel distribution submissions, Regulatory Focus 11 February 2019)
To register to use IRIS, developers must first have an active EMA account and register their organizations with the agency’s Organization Management Service; appropriate user access role and affiliation must also be identified.


© 2022 Regulatory Affairs Professionals Society.