EMA Launches Data Standards Implementation Guide: The Time to Act is Now

The EU IDMP Implementation Guide version 2.0 (EU IG), for the submission of data on medicinal products, sets out the implementation requirements of the ISO IDMP standards in the EU and triggers the countdown to the implementation of IDMP in Europe. With the clock ticking, life sciences companies doing business in the EU need to start getting their data in order and processes in place. In addition to the data requirements of ISO IDMP, the new Target Operating Model (TOM) implies that existing processes within life sciences companies need to be amended to collect more data and at an earlier point in the current process.

In parallel with the launch of the EU IG version 2 on February 22, the sector’s response to the pandemic has further highlighted the pressing need for data standards — so that data may be shared to report on supply chain issues, which vaccines are administered to which patients, adverse events and for patient information.

IDMP data standards provide the opportunity to link the regulatory world with the supply chain world. Until now, the supply chain, regulatory, pharmacovigilance, and clinical functions might all use different names for the same products and active substance(s). Now these different worlds will be able to speak the same language, sharing data and terminology that will simplify manufacturing, supply chain and patient information data sharing.

Compelling use cases

Remco Munnik

There are compelling use cases for IDMP structured data exchange across life science organizations. Structured data exchange will support quality assurance by providing the ability to compare registrations across regions using common data standards.

First of all, regulatory departments will find it more straightforward to generate forms and documents from data. IDMP structured data exchange will help enhance pharmacovigilance processes, for improved signal detection of adverse events reported at a global level. And it will support the ability to generate electronic product information for patients and healthcare professionals.

The supply chain will gain the possibility to optimize the batch release process and reporting and mitigation of shortages of medicines. IDMP would make it easier to compare products across countries and regions (comparing product X in country 1 with product Y in country B).

Finally, the exchange of structured data can also enable the acceleration of regulatory processes relating to acquisition and disinvestment of parts of the product portfolio.

SPOR and TOM foundation

EMA’s Master Data Management (SPOR) and Target Operating Model (TOM) will become foundational building blocks for IDMP compliance and optimization opportunities, such as improving patient information. In order to implement ISO IDMP standards, EMA developed four domains of master data in pharmaceutical regulatory processes: substance, product, organization and referential (SPOR) data. Life sciences companies will, in many cases, need to speed up their preparations towards SPOR-readiness. Cross-functional reporting capabilities will allow different departments and systems to share SPOR data.

Practical steps

There are a number of practical steps companies may take in response to the implementation guide. The implementation of ISO IDMP and the target operating model on which companies must submit data and documents, affects process, organization, technology and information:

1. Process. The implementation of EU IG version 2 and the target operating model of submitting the data together with documents very much changes the processes pharmaceutical companies have followed for the past decades.

Traditionally, regulatory departments created and submitted documents, not data, to the regulator. In 2012, the industry began submitting some data for marketing authorization applications, but only after the regulatory assessment (xEVMPD). Now, companies need to get ready to submit data at the start of the regulatory activity relating to a new medicine or variation. And that data requirement is not limited to regulatory data only — it may include data from other sources too.

2. Organization. Awareness of the IDMP changes is likely to vary across departments. Some regulatory departments are well prepared for the implementation requirements. Others are barely aware that change is coming. Management may simply see this as another tiresome and costly compliance overhead.

Raising awareness of the challenges and opportunities is key. Providing training may be appropriate for some people. For others, it may be a matter of creating awareness and gaining buy-in to the potential business benefits and opportunities for innovation and efficiencies.

IDMP implementation is not only a regulatory change. It is tempting for regulatory departments to take ownership of collecting the data. But beyond the first iteration, a company-wide approach is best to achieve effective data governance and consistent data throughout the supply chain. For example, the composition of a medicine or vaccine may be recorded differently in systems used by regulatory department and manufacturing as presented in the final patient information leaflet. As an example, if water is being used in the manufacturing process, it may be recorded in the composition by the manufacturer but not in the final patient information leaflet, as the water dissolves during the manufacturing process. Regulatory needs to make a decision on how to handle and track these kinds of inconsistencies as they may lead to issues with the regulator.

3. Technology. Many life sciences companies have regulatory information management (RIM) systems but continue to use manual data entry. Now, RIM systems need to be able to send data direct to the EMA. Companies need to collect more data, at an earlier time, with new technology. Yet, implementation of new technology within a short time frame is challenging as pharma companies must carry out validation of any new technology to guarantee that it really works as expected. However, it is realistic to believe that in a year’s time there will be tools out there that are validated, implemented and ready.

4. Information. Data and information that companies will be required to produce and share may well be distributed across organizations in many different formats. Bringing centralized RIM data into the IDMP fold is one thing. Locating, extracting and sharing data that is buried in documents across the organization is a much bigger task. Some companies might have 50 centralized procedures, but they might have 1500 non centralized procedures that are not addressed by current technology solutions. Manual data collection is not an option at this scale. Technology can help by changing your documents into data and many pharma companies are implementing technology solutions first for centralized procedures and then turning their attention to non-centralized procedures.

Reducing delay

There are a number of challenges and opportunities that come with the EU IG. Compliance with ISO IDMP is more than just a mandatory regulatory exercise. Standardized data has potential to drive more efficient processes. Beyond that, it will support new opportunities for sharing data and automation across the regulatory and supply chain divide to speed regulatory approval and time to market. In the past, the pharma industry accepted delay created by poor data sharing as inevitable. As the world watches the roll-out of the coronavirus vaccine, unnecessary delay is no longer acceptable.

Increasingly, the industry focus is patient-first, getting drugs to patients in a much more timely manner and giving patients better and more accessible information about their medicines. There is no doubt that IDMP compliance will drive better patient outcomes. The clock is ticking. For pharma business, especially those with large complex big portfolios, the time to act is now.

Remco Munnik is Associate Director at Iperion.