The fact that the EU will soon be implementing standards developed by the International Organization for Standardization (ISO) for the Identification of Medicinal Products (IDMP) is hardly breaking news. The life sciences industry has known about the impending adoption of IDMP for nearly a decade. However, the implementation timeline has been a moving target and for many companies this has meant that preparations for IDMP, originally begun in earnest, have understandably been deprioritized.
Publication of version 2 (and the very recent publication of v2.1) of the IDMP implementation guide by the EMA earlier this year makes it highly likely that in 2022 companies will be able to begin their IDMP iteration 1 submissions, with this becoming mandatory for centrally approved products (CAPs) in 2023.
Providing and maintaining standardized IDMP data will have a far-reaching impact across life science companies for those with products approved in the EU.
With the deadline finally on the horizon, life sciences companies need to regroup and ensure their data is ready for submission. Amidst numerous delays which have occurred over the last decade, extensive data quality assessments and revisions, and project scoping and budget requests, it is easy to forget what the original intention and purpose of IDMP was.
IDMP vs. XEVMPD
IDMP represents a substantial evolution of existing pharmacovigilance reporting requirements in the EU. In addition to the data points required by the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), the following will be required:
- Manufacturing functions, processes, and registered sites for the active ingredient(s), intermediates, and finished product
- Details on the administrable dose forms and strengths for each medicinal product
- The manufactured item describing the authorised pharmaceutical form of the product and, where applicable, before transformation into the administrable pharmaceutical form
- Packaging details including the packaged item container, quantity, and material for the inner and outer packs
- Marketing status at the pack level, identifying which products/packs are on the market across the EU
- Legal status of supply (Rx or OTC) at the product level where the same status applies across all packs; at the pack level where the status differs
- Details on medicinal product composition including the origin of the ingredient, the composition grouping description and requirements to submit details for products subject to TSE, ASMF, CEP, VAMF & PMF certification
How IDMP will Make a Difference
The suite of five standards that compose IDMP have been developed in response to pharmacovigilance legislation enacted in the EU in 2012 (EU No 520/2012, articles 25 and 26). The legislation represented the biggest change to the legal framework for human medicines in a generation. The pharmaceutical industry and regulatory authorities went into the implementation planning fully aware that this would take years to deliver.
Under the legislation, all life sciences companies are required to submit detailed product data for all medicinal products approved or submitted for approval in the EU so that descriptors are common across jurisdictions. The standardized identifiers will eventually as the iterations progress provide a complete picture of every aspect of every product on the market – the indications approved, the marketing statuses, all product ingredients and manufacturers involved, down to the batch IDs.
The standards are designed to support the exchange of unambiguous and accurate product information across global regulatory and healthcare communities. The overarching goal and driving force behind IDMP is to improve patient safety through stronger pharmacovigilance and risk management. “Adverse event reports will be based on a harmonized set of product definitions, improving the quality of data used for signal management and speeding up communication, decision-making and regulatory action.” The whole system will be built on a data-centric approach using structured content so that trends in safety issues will be easier to spot and sources traced more rapidly. Safety alerts will be easier to disseminate.
Key Aspects of Compliance
The EMA has published several guidance documents explaining what will be required. The fundamentals are that:
— The EMA will create and maintain a Product Management Service (PMS), and information already residing in XEVMPD for marketed products will be migrated into the PMS. The product information will need to be qc’d and enriched via API submission to PMS to comply with IDMP requirements prior to any submission.
— When an application for marketing approval and subsequent lifecycle variations are submitted to regulators via the EU Centralized procedure, the IDMP data elements must be submitted as a Fast Healthcare Interoperability Resources (FHIR) message in the working documents folder of the electronic Common Technical Document (eCTD). This means that submitting the IDMP information is on a product’s critical path to regulatory approval.
— Having to provide the structured data at the time of submission is a significant shift from submitting XEVMPD data following receipt of approval as we do today. What this means in practice is that the regulatory authorities will have additional structured data to support their review of dossiers. Thus, Marketing Authorisation Holders (MAHs) need to ensure their Regulatory Information Management (RIM) system is up to date at all times and reflects data pending approval in addition to approved details. Aligning dossiers and data will be critical to companies moving forward.
The Time to Prepare is upon Us
In February 2021, EMA published the second version of the IDMP implementation guide, which makes it highly likely that compliance for CAPs will be mandatory in 2023 (the option to start transitioning will begin no earlier than February 22, 2022). The first step of the Targeted Operating Model (TOM) is currently being finalized and will cover CAPs only. The second step of the TOM will encompass non-CAPs.
Life sciences companies that have grown jaded over the subject of IDMP or that have put off preparations should dust off their plans and recommit to readying their organization.
Developing a comprehensive readiness plan will entail:
- Engaging with the company’s RIM system vendor to ensure that the system will be capable of accommodating IDMP requirements over a product’s life cycle. Specifically, the RIM system will need to:
> Capture all the required Iteration 1 IDMP information, in logically presented fields
> Integrate automatically with source systems, according to their Application Programming Interface (API) needs
> Cross-reference data points so that information can be entered once and populated elsewhere as needed
> Create the IDMP data elements as an FHIR message and include them in the working document folder in the eCTD for submission to the agency and where appropriate, support direct submission to PMS
- Determining the company’s priorities for enriching the data that already exists in XEVMPD on products in their portfolio (there will be at least a one-year transition period for centrally approved products). Which products and data elements should be addressed first?
- In advance of updating RIM systems, MAHs can identify complex CAPs and map these to the IDMP requirements. This will be a valuable exercise to help ensure data owners across the organization are identified
- Developing and implementing an organizational change management program with cross-functional representation, to encompass:
> Agreeing on data ownership and responsibilities
> Assessing significant changes to business processes
> Assessing the impact on outsourced work and external partners
> Delivering focused stakeholder education (to include third parties as needed)
Investing in the RIM team’s skill sets so that team members are equipped to serve as the company’s lynchpins in complying with the regulation. They will need to work across the organization to ensure that all stakeholders are aware of their responsibilities. The RIM team must also be capable of coordinating an effective quality control process, engaging with those planning submissions and preparing dossiers, and providing input into the evolving support model.
Picking up the adoption of IDMP standards will be a significant undertaking requiring careful planning and coordination across many internal functions and external partners. The objective of IDMP – to save patient lives – bears repeating, especially given the years that have elapsed since its conception: IDMP will make it easier to mine product data to safeguard patients. With that goal – and a looming compliance deadline – in mind, it is time for life sciences companies to resume their preparations accordingly.
-  EMA website accessed at: (https://www.ema.europa.eu/en/human-regulatory/overview/data-medicines-iso-idmp-standards-overview)
-  http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2008:2671:FIN:en:PDF