IDMP, A Stepwise Approach
These standards cover the following aspects to describe a medicinal product for human use:
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- medicinal product name;
- ingredient substances;
- pharmaceutical product (route of administration, strength);
- marketing authorization;
- clinical particulars;
- packaging;
- manufacturing
EMA is implementing the standards in a phased program based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization, and referential (SPOR) master data. Although ISO IDMP standards relate to human medicinal products, SPOR applies to both human and veterinary domains.
Three-step approach:
♦ Gap assessment:
The transition from xEVMPD to IDMP and remaining IDMP compliant is a complicated process as in addition to having the IDMP knowledge, it requires a thorough gap assessment of the existing data of the life science companies’ product portfolio followed by the data remediation, data cleansing and data enrichment for the life science company to become IDMP ready. Therefore, it is very important for a life science company to understand its own data, know the source of the data if the data is missing or incorrect and develop a road map to achieve excellent data quality in the IDMP format. In addition to IDMP as a requirement, data quality of high standards is basically needed for making data ready for certain objectives such as new system implementation or data migration. If the data is clean and consolidated, it is always easier to proceed with the activities such as data migration.
With Pharma companies in the EU moving in the direction to achieve IDMP compliance, it is only a matter of time before other countries such as the US, UK, and Canada will also start following the same path. Also, irrespective of the HA requirements, it will always be a step in the right direction if the life science companies take an informed decision and start aligning their data or operate the data governance by keeping IDMP as an ultimate goal.
♦ Data management:
With IDMP standards implementation, the pharma companies need to bring in a robust data management strategy to become and remain IDMP compliant. After being released in 2012, the ISO IDMP standards were updated in 2017 to bring clarity to the relationship and the data needed for medicinal products. Implementation of a data management strategy for IDMP readiness is a complex process as whilst the dedicated teams for a MAH are engaged in the data remediation efforts; they generally face the challenges such as:
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- Lack of any checkbox/indicator in the life cycle management activities to identify the IDMP relevance.
- Lack of data alignment between Module 3 documents and SmPC and RIM tool.
- Lack of all IDMP-related data fields
- Lack of regulatory application Identifier (wherever applicable, both to Marketing authorization applications and post-marketing authorization applications) in the RIM tool
- Lack of supply chain-related information such as GTIN numbers and product shortages in the RIM tool
- Lack of details related to medical device parts (wherever applicable) such as device manufacturer, its trade name, and classification.
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Therefore, it is very important for life science organizations to know their data and its complexity so that they are able to look for the resources/repositories at the right time so that the missing data could be procured to avoid problems with the data remediation later on.
Currently, EMA’s DADI project is in progress. The use of web-based eAF is now live for CAPs however, it is not mandatory. The UATs for the CAPs and NAPs are expected to be done during Q2-Q3 2023 followed by a 6-month transition period during which the MAHs would have the option to use old/new variation forms after which the use of web-based application forms will become mandatory from Q4 2023/Q1 2024.
Other than EMA, health authorities (HAs) across the world are still determining how to implement the IDMP standards. Whilst the HAs decide on how to implement the IDMP standards, the pharma/consumer product companies could explore systems and develop processes to ensure compliance and remain ahead in capturing and maintaining the data required to achieve IDMP compliance.
Once the MAHs give their data the required shape as per the IDMP requirements, it becomes critical to decide on the right tool for IDMP submissions which requires a team of experts to assess the right IDMP-compliant tool.
♦ Change management:
This step becomes relevant at the onset as the assessment of change and its impact starts before the change itself, however, managing communication across stakeholders, training, and maintaining compliance to upcoming changes is an ongoing process even beyond implementation. The success of an IDMP-compliant data management system would rely on its agility, ease of use, and compatibility with a wider set of systems within the business.
CONTINUUM could support the manufacturers with all three steps to ensure IDMP implementation and compliance. We have expertise with different RIM systems, testing different systems, gap assessment, and data governance.
