A modified implementation plan for IDMP
Since the publication of the EU Pharmacovigilance Regulation in 2012, MAHs have been required to provide specific registered, labeled and, more recently, information for all medicines approved in the EU. The EU Implementation of Identification of Medicinal Products (IDMP) is designed to further increase patient safety by supporting the exchange of clear and accurate product information between the regulatory and healthcare communities .
Throughout 2021, the European Medicines Agency (EMA) and many stakeholders from industry, suppliers and National Competent Authorities (NCAs) continued to work on finalizing data and drug requirements. process for submission of ISO-compliant data for all medicines approved in the EU. .
At the end of October 2021, the EMA communicated a change in the implementation strategy of the IDMP having adopted a more agile and data-centric approach, with a focus for 2022 on the replacement of electronic application forms by forms that will integrate and be partially populated by product data from Product Management Services PMS.
Previously, the priority for 2022 was the transition of EU centrally approved product information from the Article 57 database to the PMS with the requirement to enrich the data and then submit changes futures as a Fast Healthcare Interoperability Resources (FHIR) message located in the eCTD working folder or directly via the API.
The modified diet
Following an EMA webinar on Data Access and Interoperability (DADI) in mid-January 2022, additional information is now available
Section 57 “XEVMPD” submissions will continue to be required for the foreseeable future for all EU-approved products.
EMA’s revised strategy for 2022 will be to digitize the submission process under the DADI project. The goals are to 1) rely more on structured data to support evidence-based medicine regulation, 2) create a modern interface and streamlined end-user experience, and 3) gain efficiency.
The current electronic application form will be replaced by a new DADI form. The plan for the initial phase is to replace the current iteration of the variation form by Q3 2022. The DADI form will be populated with structured and ISO-compliant data derived from the PMS; powered with migrated Article 57 XEVMPD data for all products and data from the EMA Siamed database for centrally approved products.
Once the DADI form is completed, it will be downloaded in PDF and FHIR format and submitted with the electronic Common Technical Document (eCTD). The DADI form will capture SPOR structured data as part of the PMS modification as well as provide the narrative required for the request form. The DADI form will be completed via a portal, during initial go-live scheduled for Q3 2022, a largely manual data entry process will be implemented; there will be no direct machine-to-machine integration. It is hoped that over time relevant data stored in Regulatory Information Management (RIM) systems will be leveraged in a way that DADI form completion can be supported and therefore reduce duplication of effort and risk of data misalignment.
What to expect in 2022
The coming year will be a busy one for both MA holders and EU regulators. To maintain momentum and ensure readiness for each stage of implementation, companies will:
- Continue to submit XEVMPD data to Section 57 as before.
- Perform the UAT of the data migration from XEVMPD and SIAMED to the PMS to ensure that the data is transferred correctly.
- Develop ISO compliant data correction and enrichment processes within the PMS; whether data from RIM systems will be used to directly update the PMS via FHIR remains to be confirmed.
- Watch for updated/additional information on IDMP progress, especially in the form of an updated EMA Project Roadmap and IDMP v2.2 Implementation Guide .
- Attend future EMA webinars to learn about implementation plans as they evolve
- Engage users to understand the data and process changes that will be required.
Karen HarryDirector, Regulatory Information Management, Calyx