The global standardization of information exchange regarding medicinal products is crucial to ensure consistent regulatory compliance, enhance patient safety, and facilitate seamless collaboration across global markets. The ISO IDMP standards help to achieve this by providing a robust framework to ensure identification of products, enhance interoperability between systems, and facilitate clear communication between all key stakeholders in the pharmaceutical and regulatory landscape across the globe. The 5 standards cover substances; dosage forms, administration routes, presentation units, packaging; units of measurement; regulated pharmaceutical product information; and regulated medicinal product information.
Indeed, the adoption of these standards is also expected to enhance operations pertaining to clinical trials, regulatory submissions to authorities, and pharmacovigilance (PV).
Implementing and Adopting Change: ISO IDMP Standards
The first step of implementing and adopting ISO IDMP Standards is ensuring smooth transition. Leading by example is the European Medicines Agency (EMA) that are implementing Substance, Product, Organization, and Referential (SPOR) for centralized master data to help identify medicinal products. The 4 SPOR services cover Substance Management Service (SMS), Product Management Service (PMS), Organizations Management Service (OMS), and Referentials Management Service (RMS) that facilitate accurate identification, efficient regulations, and improved communication within the pharmaceutical environment.
Implementing SMS and PMS in the EU is an iterative process which starts with a part of ISO IDMP data fields and expands over time to completely adopt the standards. In 2019, the initial rollout of SMS allowed users to manage substance data through the EMA Service Desk with future iterations aiming to synchronize with the EU-SRS database and providing a more dedicated interface to users. PMS plays an important role in supporting all EMA products such as ePI, eAF, IRIS Portal, etc.
Transitioning from XEVMPD to ISO IDMP Standards
The eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) supports PV activities in the EU and provides an updated and comprehensive repository of medicinal products of the EU. This in turn supports the EudraVigilance system’s efficiency in identifying safety signals and assessing time in a timely manner. However, global standardization is still required which is being achieved through ISO IDMP. EMA has moved all its data from XEVMPD to PMS as per ISO IDMP standards, covering nationally and centrally authorized products. Marketing Authorization Holders (MAHs) should review the PMS for their medicinal products and share any missing data that may be required by National Competent Authorities (NCAs). However, another obstacle is that of duplicate information in various systems that may not be entirely integrated into the new systems.
MAHs will soon need to ramp up their efforts in enhancing data for their medicinal products that are national and centrally authorized. They should also review and evaluate their internal processes to find areas for improvement related to efficiency. Data cleansing is the need of the hour for quality, regulatory compliance and most importantly, patient safety.
Conclusion
Global standardization of information pertaining to medicinal products through IDMP Standards is a significant step towards enhancing regulatory compliance, patient safety, and overall operational efficiency within the pharmaceutical industry. EMA being the leader of this transformation beings initiatives, like SPOR and transition to PMS. However, this highlights the efforts required by other stakeholders, like MAHs in contributing towards refining data and scrutinizing internal processes. Not only will this collaborative effort ensure adherence to regulatory expectations, but it will also help meet the objective of improving global healthcare through more efficient and accurate exchange of information.
Reach out to DDReg to explore how we can support your transition to ISO IDMP standards, ensuring compliance, improving data management, and enhancing patient safety. Let’s collaborate to streamline your processes, reduce regulatory complexities, and drive innovation in pharmaceutical product management.
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