Background

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.

MAH Guide to IDMP team development

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.”[1] 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.

5,910

Full implementation of the PV legislation was estimated to save up to 5,910 lives per year and savings to society between 237 million and 2.4 billion Euros per year. [2]

Could IDMP have changed COVID?

The COVID-19 pandemic highlighted the criticality of structured data. With shortages in the drug supply and a dire need for global information sharing as the world has struggled to beat the virus, we can start to appreciate the value that IDMP will bring.

Imagine the power of a common data repository on adverse drug reactions related to virus treatments and vaccines… or the benefit of being able to analyse the data you are collecting for EMA to better manage the drug supply and avoid the kind of shortages experienced during the pandemic.

IDMP is just one of the structured data initiatives driven by EU Telematics, but the size of the data set and the cross-functional sources spanning regulatory, pharmacovigilance, manufacturing, and drug supply positions it for optimum impact. COVID-19 has proven the catalyst for change. Utilising IDMP to drive structured data governance across the industry will have far reaching benefits, the most important of which is patient safety.

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.

A comprehensive IDMP readiness plan involves multiple components
Figure 1: A comprehensive IDMP readiness plan involves multiple components

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.

Conclusion

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.

REFERENCES

  • [2] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SEC:2008:2671:FIN:en:PDF

The future of Calyx RIM is on Azure

Calyx RIM on Azure combines Calyx’s industry-leading expertise in global regulatory compliance with the power and capabilities of Microsoft’s scalable, flexible, and secure global cloud platform. The alliance ignites Calyx’s ability to lead the digital transformation of the life sciences industry.

As we deliver Calyx RIM updates directly to the cloud, you benefit from:

  • Accelerated return on investment through resource savings
  • Optimized workflows to drive regulatory efficiencies
  • Shortened release cycles
  • Immediate availability of new capabilities
  • The elimination of lengthy and expensive software upgrades

Why Calyx RIM on Azure?

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The explosion of data is rapidly transforming many industries, including healthcare. The cloud computing model enables efficiencies through a shared data platform while addressing the significant privacy, security, and compliance challenges that the pharmaceutical industry faces.

With Calyx RIM on Azure, you leverage the latest Azure-native technologies designed to improve regulatory efficiencies while ensuring patient safety. Through automated components and cutting-edge microservices, rapid upgrades are delivered directly to your environment, ensuring you remain regulatory compliant at all times.

The Calyx and Microsoft Partnership

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Efficiencies just got simpler.

The end-to-end Calyx RIM solution on Azure greatly reduces the burden and cost of maintaining multiple software applications on-premises or dealing with managing multiple vendor solutions, versions, and integrations. With Calyx RIM on Azure, Calyx absorbs up to 80% of our clients’ validation activities.

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Change the way you work.

Through our partnership with Microsoft, we’re integrating existing, powerful Calyx RIM functionality with Azure native technology. We are streamlining the time it takes to do common activities; removing mundane tasks and allowing your experts to focus on improving patients’ lives.

This will change the way you work, drive efficiency, and in many cases, reduce or remove the need for training in the Calyx RIM system, particularly for occasional users.

We are developing innovative approaches to tackle the challenges faced across the pharmaceutical industry with regard to data and the management of regulatory information.

Calyx’s regulatory solutions vision

To develop innovative approaches that tackle the challenges faced across the pharmaceutical industry for the management of regulatory information so that you can focus on improving patients’ lives.

Innovating the future of RIM.

The depth and breadth of Calyx RIM includes decades of regulatory and user experience. Calyx’s track record over the last decade highlights our ability to provide products and services which optimize end-to-end regulatory affairs process throughout the product lifecycle.

With Calyx RIM on Azure, we move beyond simply enhancing versions of existing products to creating entirely new, advanced solutions for the next generation of challenges you face. Our alliance with Microsoft is about so much more than just hosting; we are accelerating innovation and delivering more value to you by embedding Microsoft’s ever-evolving technology into our solutions.

This is why we have come together with Microsoft. The collaboration focuses on delivering patient centric solutions at a predictable cost on a secure cloud platform, leveraging Calyx’s life science expertise and Microsoft’s high velocity, innovation setting precedents to accelerate drug development.

Five Key considerations

As the industry turns toward data-centricity, optimizing the management of your regulatory submissions and product data maintenance becomes ever more critical. Investment in strategic regulatory initiatives and Regulatory Information Management (RIM) capabilities continues to be a priority across the industry.

Five Considerations for Adopting RIM

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1. DATA QUALITY SUSTAINABILITY

Data governance, compliant regulatory submissions, extensive data sets for XEVMPD/IDMP compliance.

Use your RIM system for onward sustainability of these to manage your data and publish your structured data submissions.

Aligning with your day-to-day regulatory processes promotes sustainable data.

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2. OPTIMIZED PROCESSES

Optimized business processes are critical for a global regulatory team to operate effectively in today’s fast-evolving environment.

Harmonized processes across corporate and subsidiary operating sites:

  • Optimize resources
  • Reduce cycle time
  • Increase data quality
  • Ensure submission compliance
  • Decrease data entry burden
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3. REALIZED BUSINESS BENEFITS

Drive optimal performance by laying the foundation of your organizational strategy.

Process and system maturity promote trust in your data. Leverage that data to make informed business decisions.

Maximize your business benefits via strong data visualization capabilities in your RIM platform.

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4. ORGANIZATIONAL COMPETENCY

What is the outcome of organizational competency?

  • Harmonization
  • Standardization
  • Collaboration
  • Eliminated waste
  • Reduced costs
  • Accelerated product release

The bottom line? More effective operations drive more competitive advantages in global markets.

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5. CONNECTIVITY

Make the most of your best-of-breed systems throughout the organization.

Establish a source of truth and eliminate the distraction of extensive change management programs. The touch points from your RIM data to the rest of the organization make this paramount.

HOW TOP PERFORMERS ARE CONNECTED

Top-performing organizations are eight times more likely to have established a connection between their RIM system and Safety, and three times more likely to have established a RIM connection with product supply and product change control processes, compared to their counterparts.

What Can You Expect?

A modern and compliant system, Calyx RIM delivers:

  • Harmonized data and compliant, high-quality submissions
  • Expedited time-to-market resulting from improved processes
  • Operational and cost efficiencies
  • More focus on core competencies by regulatory resources
THE ABILITY TO TRACK, MINE AND ANALYZE DATA WITHIN YOUR RIM SYSTEM IS CRITICAL TO REGULATORY COMPLIANCE AND, ULTIMATELY, TO PATIENT SAFETY.

A Trusted Partner

Calyx uniquely combines regulatory cloud technology with the depth and breadth of our regulatory expertise to deliver a scalable and flexible RIM solution that yields predictable year-over-year savings and addresses regulatory complexities, increased workloads, and limited budgets facing the industry.

Calyx RIM for Office 365

Calyx and Microsoft together are delivering exciting new capabilities for our Regulatory Information Management (RIM) system that will change the way you work. It’s more than just a new feature — we have looked at the human factors of everyday regulatory operations tasks and workflows, and are introducing an entirely new way to interact with Calyx RIM.

The power of Calyx RIM, surfaced within Microsoft Office 365, elevates your productivity, utilizing machine learning and automation to simplify everyday tasks and bring RIM functionality into the tools where you already work.

KEY FEATURES

  • Access key Calyx RIM capabilities directly within Microsoft Office
  • Initiate submission workflows
  • Create or update sequences and references
  • Easily attach the target email and related attachments to the workflow
  • Automatically generate email notifications to keep interested parties updated on submission progress
  • Smart AI provides pre-population of data fields based on email content

Making the Complex Simple

Through automation and workflow — getting the right information and documents recorded in the right place — we take the compliance burden off the user to help ensure the process is done the right way every time. This eliminates multiple touchpoints and the back-and-forth emails and phone calls that are often needed to confirm everything is in the right place.

IMPROVE COMPLIANCE

By notifying you when a message from a regulatory authority is received, and facilitating the collection of required information without ever leaving Outlook, we help you adhere to compliance requirements effortlessly.

BETTER USER EXPERIENCE

By surfacing regulatory workflow directly in the tools with which you’re already comfortable, Calyx RIM for Office 365 is a huge leap forward for the casual user who does not live their lives in the RIM system every day.

Our technology partnerships are part of our commitment to, and passion for, innovation.

Calyx RIM for Office 365 is available through our alliance with Microsoft — indicative of Calyx’s longstanding and ongoing drive toward innovation. Built on Microsoft Azure, an open, enterprise-grade, secure cloud computing platform, Calyx RIM for Office 365 brings together Calyx’s global biopharmaceutical expertise with Microsoft, the world’s largest software company. This world-class cloud architecture is designed to deliver cost-effective innovation while safeguarding sensitive information and ensuring that data are properly managed and protected in a dedicated, private environment.

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