From 19 October 2020, drug developers will have to use the European Medicines Agency’s (EMA) IRIS Regulatory & Scientific Information Management Platform to request scientific advice.
At any stage of a medicine’s development, a drug developer can ask for scientific guidance and direction from EMA on the best methods and study designs to generate robust data on efficacy and safety.
The IRIS platform 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 the substance, product, organisation and referential (SPOR) portal. Currently, IRIS is used to apply for orphan designation, notification of parallel distribution, briefing meetings with EMA’s Innovation Task Force, and to request Research Product Identifiers for new medicinal products. The procedures that are transitioning to IRIS access include initial and follow-up inquiries regarding scientific advice, protocol assistance and qualification procedures.
Applicants must first register to use IRIS. Thereafter they can submit requests, documentation and other information to EMA relating to scientific advice procedures.
EMA’s move to the IRIS platform for scientific advice requests is part of their larger digital transformation movement.
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