IDMP is a set of five standards produced by the International Organization for Standardization (ISO) to help with the identification of medicinal...
What the IDMP Ontology is and how it enables patient safety
The IDMP Ontology is essential to building safety for patients and adhering to regulatory compliance. The next step is an IDMP software to resolve the issue.
IDMP Ontology Project
Proper and full implementation of the ISO-IDMP standard is expected by regulatory bodies in the year 2023. It is therefore crucial for pharmaceutical companies to implement a solution that not only solves that issue but is also sustainable.
Various Pharmaceutical companies, the Pistoia Alliance and Accurids have come together to create a. IDMP Ontology.
Having a well-defined ontology that bridges the gap between regional and functional perspectives on common substance-related data items and global and scientifically objective representations is crucial. Our project's purpose is to create an IDMP Ontology that enables deep, semantic interoperability based on FAIR principles to improve and supplement the existing ISO IDMP standards.
Why is the implementation of an IDMP Ontology necessary for pharmacovigilance?
The governance of critical IDMP standards and implementations is not delegated to a single governing body. Diverse IDMP implementations across geographical areas and legal domains are already leading to variations in interpretation between implementing entities.
Given the lack of semantic coherence among regulatory bodies, there is a concern that regulatory compliance requirements may result in high integration and interoperability costs, limiting the benefits of IDMP in medication safety, innovation, and other areas.
Organizations will struggle with data concerns, such as the requirement to map product data across the company and throughout the product lifecycle, rather than focusing on developing new medications.
Today’s IDMP implementations in various organizations are diverse, built-in silos, not fully standardized and have already created inconsistencies of interpretation.
By implementing the IDMP Core Ontology, data can be managed and governed in accordance to the FAIR data principles
As a solution to the mentioned challenges, the IDMP core ontology has been developed by the Pistoia Alliance, in co-operation with various big pharmaceutical companies. The goal is to enable deep, semantic interoperability based on FAIR data principles to augment the existing ISO IDMP standards of the European Medical Agency.
With this IDMP Ontology, corporations can ascend to a decreased risk of compliance issues as well as burdens from a regulatory side, providing a decisive advantage in the overall market situation.
This will ultimately enable entirely new ways of collaboration and enable early adopters to gain a competitive advantage in innovation, drug safety and overall operational efficiency.
How does the IDMP Core Ontology project address the issues your company may face soon
The Pistoia Alliance was chosen to administer this program, which aims to develop a minimum viable product (MVP) ontology that adds value to the ISO IDMP standards for data usability across organizational borders and regulatory countries. For this initiative, the Pistoia Alliance has assembled a core team comprising pharmaceutical players, regulatory authorities, standards organizations, non-profit organizations, and solution suppliers.
Building a custom solution IDMP software poses many hurdles, such as high cost, long time to deployment as well as ongoing costs of maintenance. It is therefore economically as well as functionally smart to implement an IDMP software that is already deployed and that has been developed in accordance with various pharmaceutical companies.
Target benefits in a regulatory context
- ensure wide interoperability across global regulatory and healthcare communities for accurate analysis and unambiguous communication across jurisdictions.
- pharmacovigilance: 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 actions;
- regulatory submissions will use a consistent standard to capture and manage data, allowing information on medicinal products to be shared and re-used across different procedures and among various regulators (subject to confidentiality restrictions);
- clinical trials: stakeholders will access clinical trial data using agreed and well-supported standards, improving the assessment and scientific evaluation of medicines as well as communication and transparency;
- good manufacturing practice: inspections of manufacturing sites will be based on accessible information, which streamlines inspections particularly for urgent situations involving defects. Faster detection of falsified medicines can also be supported as a result of consistent data standards.