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.
Spain completes the ePI pilot (29/04/2024)
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.
PMS Info Day helps drive Product Data readiness (29/04/2024)
EMA, NCAs and representatives of industry gathered in Amsterdam on 16 April 2024 to review what industry and regulators must do to ensure complete and correct product data in EMA’s new medicinal product database, PMS. EMA is currently developing the Product User Interface hosted on the PLM Portal, as well as an system to system interface to enable companies to enhance their data.
PMS Data Viewing capability to go live in May 2024 & 2024 roadmap (29/04/2024)
The PMS Product User Interface and Application Programming Interface will be launched on 31 May 2024 in read-only mode. marketing Authorisation Holders will be able to view Centrally Authorised Product - CAP- data in the user interface, while the system-to system interface offers the possibility to view CAPs and Nationally Authorised Products.
Updated CAPs data now available in web-based eAF (29/04/2024)
Updated CAPS data has been loaded to the web-based eAF, where users will be able to see this data in their forms. This step is part of European Medicines Regulatory Network’s transition from interactive PDF-based applications forms to web-based forms. Due to ongoing data checks, EMA recommends not to use the web-based form pending final data testing. Please use the interactive PDF eAF instead.
Vendor workshop lays groundwork for forthcoming eCTD v4.0 pilot (29/04/2024)
The European Medicines Regulatory Network aims to start a technical pilot for eCTD v4.0 later this year. For the pilot to succeed, it is pivotal to create an ecosystem to support it – including eCTD compiling capabilities. This is why EMA hosted an electronic Common Technical Document tool workshop on 27 March 2024 for vendors interested in the changes to the EU regional eCTD Specification.
Majority of procedures to move to IRIS Portal in 2024 (29/04/2024)
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.
A New Look for the PLM Portal (29/04/2024)
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.
Two highly requested usability features to be launched on UPD in June (29/04/2024)
EMA will implement two highly requested features in the UPD in June.
Two new VNRA codes added to RMS list of Variation Classification (29/04/2024)
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.
Training Webinar - PMS Product UI and API access & navigation (03/06/2024)
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.
Update Webinar - Regulatory Procedure Management Transition to IRIS - for Industry (13/06/2024)
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.
Update Webinar - Regulatory procedure management transition to IRIS - for Network (18/06/2024)
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.
Livestream - Catch up on latest developments in SPOR (10/07/2024)
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).
