As a continuation of the current xEVMPD mandate (Article 57), the European Medicines Agency (EMA) is in the process of defining and implementing new standards based on the ISO standard for the identification of medicinal products (ISO IDMP). While primarily a regulatory obligation to improve patient safety, the new standard also provides the life sciences industry with a unique opportunity to standardize product data, drive operational efficiency and compliance throughout the organization.
The challenge for the industry however is more than the evolution of xEVMPD. The data captured in the ISO IDMP standard is much greater and would require the involvement from not only the regulatory department but also others such as manufacturing, label management and clinical amongst others. Companies are beginning to understand that the diverse information which exists in their organization to support the ISO IDMP standard is only available on paper or non-structured formats like PDF. As such, the solution required is not only about regulatory compliant submissions but also of data standardization and consolidation within their organization.
Although the deadlines for the compliance mandate are not yet finalized, it is clear that with the size of the challenge at hand companies need to start working on this now.
LifeSphere IDMP™ provides companies with a complete IDMP solution which addresses the technical, business and compliance challenges that companies will confront on the road towards addressing the IDMP regulations coming from the EMA and other regulators.
Using its flexible interface layer, companies can collect information from different sources, consolidate, map and transform information before filing it into a central repository that conforms to the complete ISO IDMP model for managing product information. Users can then review, enrich and verify the data before submission to the regulatory authorities. The enrichment and cleaning of data is key to ensure completeness of information, especially considering that much of the IDMP information is only available in unstructured or paper format. The LifeSphere IDMP™ workflow component also ensures that a suitable review process is in place before final submission.
For the submission process, LifeSphere IDMP™ relies on the proven technology used for safety (E2B) and xEVMPD submissions. With an integrated submissions gateway LifeSphere IDMP™ will manage the submission, including MDMs and Acknowledgements provided by the authorities, as well as the management of the IDMP IDs which is critical to ensure the global use of the IDMP standard.
Adopting IDMP also provides opportunities to enhance compliance within the organization. To address this, LifeSphere IDMP™ also allows for exchange of information with other systems which can be either direct or leverage the integration layer used in the data collection process.
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- Beyond Compliance Using IDMP to Improve Efficiencies Within Your Organization
- IDMP 101 – An overview of IDMP
- Regulatory Beyond IDMP Benefits of Regulatory Information Management Systems
- Preparing for ISO IDMP Implementation : Latest updates from ISO and the EU Task Force