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Thanks Remco Munnik for sharing this insightful update on the Spanish webinar. It’s truly inspiring to witness the significant progress being made by the Spanish Agency. They are not only paving the way for the successful implementation of IDMP but also demonstrating how National Competent Authorities (NCAs) are preparing for this transformation! Who’s next? #IDMP #SpanishAgency #NCA #DataManagement #RegulatoryExcellence #Innovation #Webinar #Compliance #Pharma #Collaboration #Progress

??Key updates from EMA′s first quarterly system demo in 2025 ??? ?(26 March 2025) ??PMS PUI enrichment: EMA is developing a bulk update function to improve the efficiency of enrichment, and it is expected to be launched by end of Q3 2025. Meanwhile, the deadline for critical medicines enrichment remains set for the end of 2025. For MAHs with products listed at the ULCM, it’s time to start the enrichment of your product data. ??electronic Application Form (eAF): As of February 2025, the optional use of Human variations eAF for non-CAPs started. EMA expects to transition to recommended use in Q2 2025 for streamlining the submission process.?? ? Stay informed for more updates! ???? #EMA #PMS #SPOR #eAF #RegulatoryAffairs #IDMP?

?? EMA has announced the effective date of ICH Good Clinical Practice (GCP) guidelines (Revision 3) --> Get ready for it. ? ??WHAT? A final version of the ICH GCP guidelines Revision has been published in Jan’25. It is essential that organizations stay up to date with these changes and adapt their practices accordingly. ?? WHY? Adherence to ICH GCP is not just a regulatory requirement, it is a cornerstone of successful clinical trials. ?? WHEN? EMA announced that the current version ICH GCP (R2) remains in effect until 22Jul25 while ICH GCP (R3) - Principles & Annex 1 - will be come into effect in July’25 --> It is time to start transitioning to the new version. ?? HOW? Deloitte can guide you through the complexities of GCP compliance, helping your trials meet global standards efficiently (e.g., gap analysis, identify improvements, customized roadmap,…) ? Together, let's embrace these changes that will enhance the efficiency and integrity of clinical trials. Please reach out to us to learn how we can support your organization’s needs. #ICH #GCP R3 #Clinical Trial #Compliance

??PMS PUI write access is coming At the recent SPOR status update webinar and updated PMS roadmap release, European Medicines Agency confirmed the PMS Product User Interface (PUI) write access for non-CAP for MAHs will be available from 31 January, currently limited to pack size and manufacturer data. Here is what you can look forward to in the first half of 2025: January 2025: ??Write PMS API Implementation Guide (IG) was published on 21 January. ??Single updated edit functionality release in the PUI for non-Centrally Authorised Products (non-CAPs) MAHs and updated PUI Navigation guide is expected to be published on?31 January, aligning with the upcoming ESMP full go-live for MAHs reporting. Q2 2025: ??Bulk update edit functionality release in PUI for non-CAPs MAHs & updated PUI Navigation guide – for MAH users only ??Application Programming Interface (API) write access for MAHs (following MAHs UAT with vendors) ??Next actions for you as MAH: ·?From 31 January: Submit structured data for pack sizes, and manufacturers (information required by ESMP) to PMS PUI for all your non-CAPs listed in the “Union list of critical medicines: XEVMPD/PMS entries”. Legal deadline: December 2025. ·?From Q2 2025: Optionally submit data carrier ID for your non-CAPs using Product UI. This information will be used to connect the PMS Medicinal product with the relevant ePI. ·?You can submit pending MRPs/DCPs to XEVMPD if they need to submit a variation using the web-based electronic Application Form (eAF) for a procedure where the product is authorised in the Reference Member State, but the authorisation is under evaluation on the Concern Member State(s). ·?Submit pack sizes in XEVMPD following Chapter 3.II instructions in order to support the ESMP project that will require information at pack size level for products listed in the ULCM. ·?Verify your data submitted to XEVMPD is correctly displayed in PMS – for both CAPs and non-CAPs (either through the PUI or the PMS API) – to make sure the data submitted to XEVMPD is correctly migrated into PMS. Stay tuned for more updates, and let's get ready to embrace these new functionalities for enhanced data management! #PMS #SPOR #EMA #RegulatoryAffairs #IDMP

?? Updates to the xEVMPD user guidance ?? Did you know the European Medicines Agency made updates to chapter 3.ii of the xEVMPD user guidance? The most important changes for MA holders: ?? Add M3 documents as a reference where needed (i.e. when there are discrepancies between substances in M3 vs the SmPC) ?? New process for MA transfer: the first xEVPRM that invalidates the record needs to contain the new MA holder already ?? French MAs: use CIP codes on pack size level (or CIS code at cross-packaging level) instead of the confidential NL code ?? New status ‘valid – pending national phase’ is now available for MRP and DCP to support the load into XEVMPD/PMS before completion of the national phase Make sure you and your vendor follow the new guidance to ensure availability of the right data in PMS! #XEVMPD #EMA #RegulatoryAffairs #IDMP #SPOR

?? Are you excited about the New Year and New Capabilities? Explore the acceleration of preparing for EMA ESMP Reporting with Deloitte's Generative AI Tool! ?? ? With our cutting-edge Generative AI capabilities, we can streamline manufacturer data collection preparation for the upcoming EMA ESMP mandatory shortage reporting. As highlighted in our previous post, the EMA’s recent webinar on PMS submissions announced the ESMP launch early next year. ? Key deadlines include: ?? February 2025: Mandatory reporting for products on the ULCM, including xEMVPD Pack Size Submissions. ?? December 2025: PMS Submissions need to include Manufacturer, Operation Type, and structured Pack Size data. ?? Optional Reporting will also be available for non-ULCM products. ? Why This Matters: The EMA plays an important role in monitoring and mitigating critical medicine shortages, ensuring a coordinated and effective response. By utilizing detailed manufacturing insights, we help maintain adequate supply and prevent crises. ? Our Case Study: Recently, we completed a project for a top 5 Pharma company, extracting and remediating their full set of manufacturer data. This included extraction from M.3.2.S.2.1 and M.2.P.3.1 documents and mapping to OMS Loc IDs and RMS functions. ? ?? With our GenAI-tool, we significantly reduced the time required for extraction and mapping compared to manual methods. No matter the portfolio size, we can extract, remediate, and transform data into the desired format within weeks. ? #GenerativeAI #Pharma #EMA #ESMP #IDMP #DataTransformation #AI #MedicineShortage #Efficiency #SupplyChainManagement

Dear LinkedIn followers, we wish you a joyful holiday season! ?? For those seeking the perfect read during the festive period, the EMA has got you covered with some exciting new material. ?? Exciting Update! Today, EMA published a new version of its ISO IDMP Implementation Guide – Chapters 2, 3, Annex A to Chapter 5, and Chapter 9. Main updates on version 2.2 of Chapter 2 - Data elements for the electronic submission of information on medicinal products for human use: ?? Introduction of new elements to match the implementation of SPOR services: Introduction of Packaged PMS ID (as section 5.1) Manufacturer references at medicinal product and manufactured item levels as new data elements ?? Introduction of the PMS label in applicable RMS lists for better clarity: Introduction of a “PMS” (RMS ID 200000027036) label in the “IT Application Applicability” RMS section of the applicable term of the lists ?? Updated numbering of Chapter 2 sections: Manufacturer (previously as 1.20) was separated as a new section (section 2) ?? Updated reference to RMS lists: References to newly created RMS lists and updates to existing ones to support PMS data entry ?? Updated technical information: Updates on conformance, data type, value, ISO/FHIR elements name/paths, and FHIR Complementary Information Version 3 of Chapter 3 - Process for the electronic submission of medicinal product information introduces the process of enrichment of missing PMS data and data elements subject to be enriched. Chapter 5 Annex A - Product data elements accessible by stakeholder group was updated with the latest data element list referred to Chapter 2. Version 2 of Chapter 9 - Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas includes the update on the deltas for products authorised in Luxemburg. In December 2024, the grouping criteria for the products authorised in Luxemburg changed to be the same as the products authorised in Belgium. #EMA #ISOIDMP #RegulatoryAffairs #DataSubmission #SPORServices #PMSData https://lnkd.in/dVP6WR4S

EMA has published their electronic Product Information (ePI) pilot report! ? The one-year pilot resulted in the successful creation and publication of ePI in real regulatory procedures at EMA and the NCAs of Spain, Denmark, the Netherlands, and Sweden. Whereas EMA has identified recommendations and improvements to further develop their ePI initiative in 2025, the pilot concludes that stakeholders – including pharmaceutical industry – should incorporate ePI into their planning and preparation activities. ? Through attached poll, we would like to know your opinion on ePI readiness and plans. If you are not sure how to position ePI within your company, feel free to drop us a message. ? Interested in reading the full ePI pilot report? You can find it here: https://lnkd.in/dRU5VMFm #electronicproductinformation #ePI #EMA #ePIpilot #pilot #digitaltransformation

Yesterday in EMA′s quarterly system demo, the recent developments on electronic Product Information (ePI) were presented. Besides the anticipated ePI pilot report (expected to be published next week), EMA improved the ePI versioning, developed PMS linking, and the testing of FHIR import functionality has started. ? With ePI being an established topic on EMA’s list of upcoming digital transformations, it is important to already start asking yourself the below questions. ? Uncertain how ePI impacts your company? Feel free to reach out to us for a chat!? ? #electronicproductinformation #ePI #EMA #systemdemo #digitaltransformation ?

It is amazing to receive such great feedback on the “Decoding electronic Product Information” course for LS Academy we provided last week! We really enjoyed sharing the latest developments on ePI implementation and engaging in discussions with you. ? Missed the session? Find below our three take-aways: 1. Multiple regulators are advancing e-labelling initiatives. With EMA’s investment in digital transformation and the ePI pilot now concluded, next steps are planned for 2025.? 2. Taking control of your PMS data, understanding FHIR, and integrating the use of the PLM Portal in the organization are essential fundamentals for a successful ePI adoption. Our observation with other digital transformation projects? The effort and timelines required to successfully integrate the required changes are often underestimated by industry. 3. With this inevitable ePI change, it’s fascinating to see how new technologies such as Artificial Intelligence bring new opportunities to accelerate the generation of labelling documents.?? ? Do you have questions about ePI and would like to discuss ePI in more depth with us? Remco Munnik and Nadia Goutziers are happy to help. #ePI #DigitalTransformation #eLabelling #PMSDataManagement #FHIR #PLMPortal #AIinPharma #LabelingInnovation #RegulatoryAffairs ?