On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific applications, for industry and individual applicants" which included details on Registration of an MAH i-SPOC on supply and availability.
IRIS:
(The Iris, or “Blue Flag”, is a plant used in healing and medicine since ancient times. In Greek mythology, Iris was a messenger to the Gods who carried the “Caduceus”, or staff, now found at the centre of the international symbol for medicine).
The IRIS platform facilitates the exchange of regulatory and scientific information between EMA and organisations developing medicinal research products for potential use in the European Union.
A secure online https://www.ema.europa.eu/documents/other/iris-guide-applicants-how-create-submit-scientific-applications-industry-individual-applicants_en.pdfplatform for handling product-related scientific and regulatory procedures with EMA.
This guide has been produced to show applicants how to use the IRIS platform to prepare and submit an application and/or data for a scientific procedure (orphan designation application, scientific advice, ITF briefing meeting requests, marketing status reports, inspections and veterinary signal management) and related activities.
If you want to know more details on how to create, draft & submit new submissions and more in detail on types of submissions, etc, click this LINK.
Accelerating Clinical Trials in the EU: Publication of 2022-2026 Workplan:
Also on the same day, The European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) published the 2022-2026 work plan of the initiative Accelerating Clinical Trials in the EU (ACT EU).
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