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IDMP Compliance – What Pharmaceutical Companies Need to Know

In today’s pharmaceutical landscape, compliance is not just a regulatory obligation but a strategic imperative, especially with evolving global standards like IDMP (Identification of Medicinal Products), making it paramount for pharmaceutical organizations to stay compliant. But what exactly is IDMP, and how can companies ensure compliance?

Let’s delve into the essentials, deadlines, technological solutions, and the role of experienced partners like Celegence in navigating this complex terrain.

Overview of IDMP Standards

The ISO IDMP standards consist of five international standards that provide a framework for uniquely identifying and describing medicinal products using several identifiers such as MPID, PhPID, SubID, BaID, and UoM. These standards aim to enhance patient safety by ensuring the clear identification of medicinal products, thereby improving communication of product information across international borders and healthcare systems.

The EMA is leading the implementation of IDMP standards, supported by its SPOR data management services of which Substance, Organisation and Referential are already operational. EMA is developing a Product Management Service, user interface (UI), and API to ensure accessible IDMP data for all stakeholders. Additionally, a web-based application form has been developed to align with IDMP standards and support the Product Management Service (PMS).

Pharmaceutical companies need to adhere to stringent deadlines for IDMP compliance. While the initial deadlines have been extended, the importance of proactive compliance measures cannot be overstated. Missing deadlines can lead to regulatory repercussions and market access challenges, underscoring the critical need for preparation.

Adhering to EMA’s recommendations will not only ensure compliance but also streamline the data migration process, avoiding potential delays and impacts on product management and distribution. Therefore, it’s crucial for MAHs (Marketing Authorization Holders) to prepare for the upcoming changes, leveraging resources and expertise to meet the evolving regulatory requirements effectively.

  • Read PMS API and product Ul is available to industry where they can review the PMS data by end of May-2024
  • Industry to make sure correct level of access is raised for the individuals
  • CAPs and NAPs data will be available in PMS API and Product Ul by end of Q3 2024
  • Industry to check the data in PMS and make modifications accordingly through XEVMPD
  • Industries can monitor and review 3rd Acks received from EMA in the real time Companies should enrich Manufacturer data as per Module 3 documents for NAPs by December 2025
  • Companies should submit Structured pack size data for NAPs before December 2025
  • Companies should start submitting separate xEVMPD submissions for each authorisation provided at pack level if only one submission is made for all pack sizes
RIMS/Internal systems:
  • Industries can proactively manage comparison of xEVMPD data within their internal systems and EMA database
  • Companies can start collecting the data which won’t be coming from either XEVMPD or SIAMED II (75 fields in total)

IDMP and AI – What the Future Holds?

The convergence of IDMP and AI heralds a new era of regulatory compliance. AI-driven solutions can automate data extraction, classification, and validation, enhancing data accuracy and accelerating the compliance process. As regulatory requirements evolve, embracing AI is imperative for staying ahead of the curve.

AI not only streamlines the IDMP compliance process but also offers predictive analytics capabilities, enabling companies to anticipate regulatory changes and proactively address compliance gaps. By leveraging AI-driven insights, pharmaceutical organizations can optimize their regulatory strategies, minimize risks, and seize new opportunities in the global market.

IDMP Software That Can Help with Compliance – Dossplorer™

Navigating the complexities of information gathering to make the product portfolio in compliance with EU requirements is no small feat. Celegence offers cutting-edge IDMP software powered by AI and advanced technology. Our platform streamlines the laborious process of data management, ensuring accuracy and efficiency. With Celegence, pharmaceutical organizations can significantly reduce compliance costs and streamline regulatory operations.

Celegence uniquely combines operational and strategic expertise with our exclusive cloud-based dossier management solution, Dossplorer™, to streamline your IDMP management process, as an end-to-end service. Create a flexible and forward looking IDMP data process using our advanced technology.

Our AI enabled software is designed to simplify the IDMP compliance journey, offering features such as automated data extraction, classification, and validation. By harnessing the power of AI, we enable companies to overcome the challenges of data standardization and integration, ensuring seamless compliance with IDMP requirements. Moreover, our platform is scalable and customizable, allowing organizations to adapt to evolving regulatory mandates and business needs.

Challenges of IDMP implementation

The implementation of the IDMP standards presents several challenges for the pharmaceutical industry:

  • Data Quality across documents (Labelling, Module 3, Application Form & Internal systems)
  • Data Extraction from different sources
  • Data Cleansing and Validation
  • Data Governance
  • System Upgrades and Integration (Data Migration)
  • Process Re-engineering
  • Change Management

IDMP Compliance Solution: Experience and a dedicated team, leveraging in-house AI, ensure accuracy from the outset.

At Celegence, we understand the challenges of IDMP compliance firsthand. Our experienced team combines domain expertise with groundbreaking AI technology to deliver unparalleled solutions.

Our IDMP Package Services:

  • Business Process Definition and Training ​
  • Data entry and data submission for XEVMPD, IDMP, SPL, and other formats as needed ​
  • Data acquisition and management — capture data from legacy repositories, data correction, audit of previously submitted data ​
  • Ensure all new mandatory and conditional elements are implemented correctly ​
  • Ensure a simple data transfer in either a one-time or phased approach ​
  • Monitor developments in global and regional standards and assess the impact on your business processes and technology

With Celegence’s end-to-end IDMP compliance consulting services & solutions, pharmaceutical organizations can achieve:

  • Cutting IDMP and Data Management costs in half
  • Groundbreaking AI/technology streamlining laborious processes
  • 50%-time savings on IDMP processes compared to competitors and manual methods
  • 99% first-time acceptance of data and documentation
  • Pricing >20% lower than competitors
  • Leveraging AI and technology to halve laborious IDMP time

We believe that experience and expertise are key to ensuring IDMP compliance success. Our team works closely with clients to understand their unique challenges and develop tailored solutions that meet their specific needs. With Celegence, companies can navigate the complexities of IDMP compliance with confidence, knowing that they have a trusted partner by their side.

Key Findings from the RAPS Survey

  • A recent RAPS survey underscores the industry’s readiness and investment in IDMP compliance.
  • 59% of organizations are in pre-implementation stages, indicating a proactive approach to compliance.
  • 52% of organizations plan to invest further in tech for IDMP in the next year, and 55% in the next two years.
  • Over half of the surveyed organizations plan further tech investments in the next two years, reflecting a commitment to leveraging technology for compliance.
  • The survey highlights knowledge of the changing global regulatory landscape as the top skill for regulatory affairs professionals.
  • This underscores the demand for expertise in navigating regulatory complexities like IDMP, emphasizing the importance of staying informed and adaptable in the ever-evolving regulatory environment.

In conclusion, IDMP compliance is not just a regulatory box to tick; it’s a strategic imperative for pharmaceutical organizations. By leveraging advanced technology, experienced partners like Celegence, and staying abreast of regulatory developments, pharmaceutical companies can navigate the complexities of IDMP compliance with confidence, ensuring both regulatory adherence and competitive advantage in the global market.

Connect with Celegence, led by Sonia Veluchamy, to address any IDMP regulatory concerns and discover how our team of experienced IDMP regulatory affairs consultants can assist you in achieving successful regulatory outcomes for your product.

Seamlessly ensure IDMP compliance with global regulatory experts and groundbreaking software from Celegence. Discover how our IDMP services can revolutionize your regulatory operations for efficiency, accuracy, and compliance. Reach out to us at to learn more.