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April 2024
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Product Lifecycle Management Insights
Developments in EMA digital capabilities to manage the authorisation and lifecycle of medicines
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Product Lifecycle Management
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Introducing Product Lifecycle Management Insights
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Keeping up with the developments in digital capabilities for authorising and managing the lifecycle of medicines can be challenging. Therefore EMA is pleased to announce the launch of Product Lifecycle Management Insights, a newsletter to help pharmaceutical companies and other medicines developers stay up to date with news and actions related to Product Lifecycle Management.
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Electronic Product Information
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Spain completes the ePI pilot
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The Spanish Medicines Agency has published electronic product information, ePI, for all regulatory procedures in scope for a one-year pilot initiative by European Medicines Regulatory Network. The pilot is to create and test ePI in regulatory procedures. This is a step towards providing information for patients and healthcare professionals in an accessible, electronic, format for medicines.
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Product Management Service
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eSubmissions
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Regulatory Procedure Management
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Majority of procedures to move to IRIS Portal in 2024
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In 2024, RPM for Product Lifecycle Management (PLM) is expanding the capabilities to support key regulatory procedures through the IRIS Portal. The aim is to manage the majority of procedures, except Initial Marketing Authorisation and other pre-submissions applications, exclusively in IRIS for all CAPs and by extension for all MAHs with CAPs starting Q4 2024.
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Other news
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A New Look for the PLM Portal
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electronic Product Information (ePI) and the Product Management Service (PMS) Product User Interface will soon join web-based electronic Application Forms on the PLM Portal's landing page. To ensure users can find and easily access these tools, EMA will update the landing page of the Portal in May 2024.
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The Portal will also get a new look and feel. This new look and format is part of ongoing efforts to improve the user experience of the Portal in line with insights gained from UX research done last year. Those that joined the system demo in December 2023 will already have seen the concept for the new page.
The new interface aims to provide more intuitive access release notes, news, knowledge articles and more related to the electronic Application Form (eAF), the Product Management Service (PMS), and the electronic Product Information (ePI).
Consider sharing your feedback on the new landing page in the PLM Portal Forum.
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Paediatric submission onboarding on IRIS from 4 June 2024
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Key paediatric submissions will move to EMA’s IRIS Platform on June 4th. In line with other procedures that have transitioned to IRS, this integration aims to significantly improve transparency and efficiency in the paediatric application process, allowing for secure and faster interaction between applicants and EMA and improved data quality through integration with other EMA systems.
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The following types of paediatric submissions must be conducted via IRIS from 4 June 2024 onwards:
- Initial Paediatric Investigation Plan (PIP)
- Modification of an agreed PIP
- Product-specific waiver
- Compliance check
- Annual report on paediatric deferred measures
- Confirmation of Applicability of a class waiver, or of inclusion of an indication within a condition
- Discontinuation of Paediatric Development
To ensure a smooth transition to using the IRIS platform, EMA strongly encourages applicants to register for access to IRIS in advance of the go-live date. The IRIS guide to registration and RPIs provides step-by-step instructions on registration, while additional information and guidance are available on the IRIS website.
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Two highly requested usability features to be launched on UPD in June
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EMA will implement two highly requested features in the UPD in June.
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First, Marketing Authorisation Holders (MAHs) will be able to save and resume draft VNRA submissions. Currently, it is not possible to do so: once started, users must complete the VNRA submission in one go, otherwise all progress is lost. The new functionality will allow MAHs to draft a VNRA submission and then resume it at a later stage within 30 days from saving the last draft.
Second, Super Users (both MAHs and National Competent Authorities (NCAs)) will be able to set-up email addresses to receive notifications via email concerning product related actions within their portfolio and under their responsibility. It will be possible to set-up different email addresses for each organisation ID, which can also be auto forwarded to other colleagues within the organisation.
In due course, a detailed video tutorial and guidance document will be made available on the UPD webpage to facilitate the use of such new functionalities.
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Two new VNRA codes added to RMS list of Variation Classification
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Two new Variation Not requiring Assessment (VNRA) codes C.10.d and C.10.e have been added to the Annex of Implementing Regulation (EU) 2021/17 and are now available for UPD users.
These codes refer to the replacement of information on the immediate or outer packaging by an abbreviation or pictogram and are available to be selected in the VNRA drop-down lists in UPD.
Further information can be found in Commission Implementing Regulation (EU) 2024/916.
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Events
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Training Webinar - PMS Product UI and API access & navigation
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Viewing capabilities for PMS product data will be launched in May. Marketing Authorisation Holders will be able to view data using the PMS Product User Interface (PUI) or a machine-to-machine interface. This training webinar will show and explain the access and navigation for these two tools. The webinar is for industry and Network stakeholders working on regulatory affairs.
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03/06/2024
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Online, 10:00-11:30 CEST
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Update Webinar - Regulatory Procedure Management Transition to IRIS - for Industry
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EMA will move the management of key regulatory procedures to the IRIS Portal in Q4 2024. Although the procedures themselves will remain unchanged, using IRIS means a different way of working for Marketing Authorisation Holders. This webinar will offer insights into the strategic direction, key milestones, and implementation approach for the coming months.
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date |
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13/06/2024
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Online, 10:00 - 11:30 CEST
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Update Webinar - Regulatory procedure management transition to IRIS - for Network
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EMA will transition key regulatory procedures to EMA’s IRIS Platform in Q4 2024. Although the procedures themselves will remain unchanged, the way information is exchanged with national regulators will change. This webinar offers an update on RPM plans, providing insights into the strategic direction, key milestones and the implementation approach for the coming months.
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date |
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18/06/2024
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Online, 10:00-11:30 CEST
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Livestream - Catch up on latest developments in SPOR
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SPOR RDM services aim to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, enabling increased data quality and interoperability, efficiencies and more effective regulatory action. In this webinar SPOR Team will share achievements and plans for RDM service activities including SMS, XEVMPD/Art.57, OMS, and RMS).
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10/07/2024
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Livestream, 10:00 - 12:30 CEST
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ISSN: 2812-0817
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Catalogue Number: TC-AR-24-001-EN-Q
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