Paolo Tomasi EMA

It was made publicly available today. Please use the EMA website link, as the YouTube URL may change again in a few weeks. 

The video has been temporarily set as private, since it required editing, but soon it will be made available as public again. Please try again on Monday, and let us know the outcome. 

The video recording of the System Demo Q4 2023 is available here. Please set resolution to 720p or 1080p for better quality/ The demo of IRIS for Paediatrics (Industry Portal) part starts at 1h08 min and lasts about 12 minutes.

The IRIS system currently does allow holders of Paediatric Regulatory entitlements to add/edit contact data for EMA and for interested parties, for PIP and waivers. However, for technical reason at present most Paediatric Regulatory entitlements are not assigned to the actual holder, but to EMA; therefore, they will not be visible to the holder until data are reconciled to the correct organisation and location ID. The reconciliation is foreseen to be completed by June next year.

There is the intention to create a "Paediatric register" similar to the already existing List of Opinions on Orphan Medicinal Product Designation in the IRIS public website, which would replace the information currently published in the standard EMA website. Until this happens, the standard procedure to amend contact information for interested parties remains unchanged.

The Quarterly Systems Demo on 19 December 2023 will include, among others, a brief preview of the development being done in IRIS for the submission of applications for Paediatric Investigation Plans and their modifications, Product-specific waivers, Compliance Check, Annual Reports on deferred measures, and other procedures managed by the Paediatric Medicines office and the Paediatric Committee. More information is available on the Quarterly System Demo webpage on the EMA website. 

Contact email and phone numbers for interested parties can be edited directly by the owner of the Regulatory Entitlement, in the IRIS Industry Portal under the "Org. Reg. Entitl." tab. The change should be immediately visible in the Orphan Register. The EMA standard website will contain references to the register, and the contacts will be removed from there eventually. There is no need to update both entries, the IRIS entry is sufficient. 

As an Industry Coordinator, you should be able to change the submission contact for a GMP Inspection, and to add Managers/Contributors to it. If this is not the case, please submit a ServiceNow ticket here: IRIS – Report an issue - Employee Center (service-now.com). 

Q&A updated 07 November 2023

Scientific Advice regulatory entitlement (RE) records are different from other REs, in that they do not actually grant a legal entitlement to the holder unlike for example orphan designations, PIP or waiver decisions, or a Marketing Authorisation. Scientific Advice REs have been introduced only to allow appropriate management of requests for follow-up SA or follow-up  Protocol Assistance.

As such, the current list of regulatory entitlements does not include them, and it is not currently possible to filter them or download them in that view. It is possible to check SA/PA RE by creating a new request for follow-up advice, where the step for selection of the RE displays a searchable list of those REs. It is of course also possible, for Industry coordinators, to search and download all submissions for SA/PA in the Submissions tab, with an appropriate filter. If you would like to propose a change to the system, please raise an incident in ServiceNow detailing your requirements. 

The full list of Orphan designations (and amendments) is now available in IRIS, in the public section of the website (no need for a user account). The register is available in the Public registers and lists section of the IRIS website, and is directly accessible at this link: List of Opinions on Orphan Medicinal Product Designation. You can download the list to an Excel file; please note that the column "grounds for opinion" is only visible for individual records and is not downloadable.