Ambitious IDMP Standards Leave Little Breathing Space

Commentary Contributed by Paul Attridge, Veeva 

July 19, 2024 | Sponsors can accelerate regulatory transformation by focusing on data, processes, and organizational models. The EMA’s Identification of Medicinal Products (IDMP) standards continues to require significant effort from biopharmas trying to keep up. IDMP was developed to ensure the exchange of reliable medicinal information by providing standard definitions for how companies define and describe products. The standards cover the entire product development lifecycle for human medicines and outline specific elements and structures for biopharmas to adopt. So far, the industry focus has been on developing a common language, ensuring data preparedness, and adopting technology to support IDMP.  

IDMP will provide benefits across the product lifecycle, including clinical stakeholders who can access trial data based on standards for better evaluation of medicines and patient safety, where harmonized datasets will allow for faster signal detection and communication. Ultimately, IDMP standards will enable greater agility and responsiveness to the patient community by regulating data intake, processing, and reuse.  

Many of the recent changes have been well received by the industry, including transforming electronic application forms (eAFs) to web-based forms and integrating them with the product database on the product lifecycle management (PLM) portal. This will reduce the burden on companies to create custom data packages for IDMP. 

The EMA’s approach to IDMP delivery—and sponsor engagement—is also now more flexible. “Big bang” implementation, which would have meant getting everything right on day one, has evolved to pilot, learn, and adapt. This benefits sponsors, particularly as the structured product data scope expands this year from 15 structured data fields to the whole “iteration 1” scope, as defined in the latest implementation guide. 

Still, there is limited breathing space. The U.S. Food and Drug Administration and Swissmedic are working to find common ground with EMA, which means IDMP will soon become the global data standard for crucial product information. This requires a scalable approach to data, processes, and governance across a company’s global footprint. 

Building A Baseline For Continuous Transformation 

Once the new web-based eAFs become mandatory for post-approval variations, a key initial activity will be to assess the accuracy of EMA’s current product data for both centrally and nationally authorized products. Companies will be asked to correct or enrich their datasets using Product User Interface (currently in development by EMA and available to the industry in 2024). 

Subsequently, other types of procedures will be enabled by the eAFs. EMA will use PMS product data for projects such as the European Shortages Monitoring Platform (ESMP) and Antimicrobial Sales & Use (ASU). In Q4, the focus will shift to updating and enriching manufacturer and packaging data via these processes. The “critical medicines” category will be prioritized to pre-empt drug shortages during crises. Such use cases were unforeseen several years ago when the main objective was pharmacovigilance. 

Companies that have not started preparing will soon encounter difficulties with data readiness, data management processes, and organization. In regulatory terms, the end of the year is just around the corner, and these initiatives can take between 12 and 24 months to embed correctly. Regulatory teams that started early are experiencing tangible benefits, including viewing data earlier because they have stronger connections with the right stakeholders. 

Journey To Better Data Control 

With an estimated increase of up to 60% more data involved than in xEVMPD, IDMP poses many challenges to data control and ownership. Over the last 12 months, sponsors tracking their progress with PLM have gradually implemented changes. Identifying and validating all relevant internal data for IDMP has been challenging since not all data are stored in databases, which means regulatory teams must search for data across spreadsheets and paper documents. 

Once found, these data must be tracked at the first point of capture and stored securely in the correct format and place. Legacy RIM repositories are not well-suited to be a single source of truth, leaving some companies to manually patch up their data before it can be sent to EMA. This involves significant cross-functional coordination, given the genesis of much regulatory information from outside regulatory (for example, in clinical, product supply, or pharmacovigilance). In other instances, it’s been time-consuming to create structured formats from information that used to be copied and pasted when shared between departments. 

Leading companies are focusing on establishing a solid data governance strategy, which includes aligning data management processes with IDMP expectations, assigning data owners and stewards, establishing clear expectations, roles, and responsibilities, and defining unambiguous data standards.  

Choosing The Right Strategy 

Identifying the right technology approach can be complex because organizations cannot see around corners to anticipate regulation changes. Approaching each new regulation with a point software solution isn’t viable, given the volume of data, documents, and content covered by the rules and evolving requirements for authorizations at different levels. For instance, treating IDMP as an add-on to the core RIM system would incur additional resourcing, costs, and technology footprint to account for local submissions in all countries. 

A unified RIM foundation is more effective than point solutions, including during the transition period between xEVMPD and IDMP. Despite key differences between the two regulations and the datasets underpinning them, the core information is the same, and it’s straightforward to set up a single data governance model. 

When all core data for IDMP can be sourced from the same system being used for regulatory submissions, teams can share responsibilities without blurring accountability (for example, when sending data to the regulator). Better accountability drives higher-quality metrics. Over time, the single data governance model will be adaptable to more decentralized datasets, like the FDA’s upcoming PQ/CMC. 

A Prize Worth Pursuing 

Instituting a structure where previously there was none, IDMP will streamline the health information exchange between EMA and the FDA. Regulatory authorities can gain more valuable insights than possible through documents alone for improved safety, drug supply management, and public health. 

Biopharma companies are attempting to solve a complex regulatory jigsaw puzzle, piecing together data, documents, technology, and processes to meet the new global standard. Without a doubt, it’s a multi-phased challenge. Yet, a life sciences sector that delivers better patient health outcomes is a prize worth pursuing. 

Paul Attridge is a senior technologist and business development professional whose experience spans more than 25 years dedicated to the life sciences industry. Paul leads Veeva's regulatory strategy in Europe. In his career, Paul has held roles in business development, product management, product architecture, software development, and professional services. He can be reached at paul.attridge@veeva.com.