London, United Kingdom & Geneva, Switzerland, April 29, 2021and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) are announcing the release of important new maps between global medical terminologies SNOMED CT and MedDRA. This collaborative effort is the first deliverable of a new agreement entered into between SNOMED International and ICH.
ICH is an international non-profit organisation which brings together regulatory authorities and pharmaceutical industry from across the globe to discuss scientific and technical aspects of pharmaceuticals and to develop ICH guidelines. Owned by ICH, MedDRA, the Medical Dictionary for Regulatory Activities, is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans and is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorised for use. SNOMED International is the not-for-profit organization that owns and maintains SNOMED CT, the world's most comprehensive clinical terminology with over 350,000 concepts ranging across diagnosis, signs and symptoms and tens of thousands of surgical, therapeutic and diagnostic procedures.
This joint effort has produced two independent maps (MedDRA to SNOMED CT and SNOMED CT to MedDRA) which have been derived from frequently used and key pharmacovigilance MedDRA terms identified from the European Medicines Agency and the UK's Medicines & Healthcare products Regulatory Agency. In addition, a set of COVID-19 related terms are also included in the first production release of the maps to capture important aspects of the pandemic.
The maps are intended to facilitate the exchange of data between regulatory databases (which use MedDRA) and healthcare databases/electronic health records (which use SNOMED CT). In one use case, key pharmacovigilance concepts coded in SNOMED CT in an electronic health record (EHR) could be converted to MedDRA for the purpose of adverse event reporting to regulatory authorities or for the purposes of epidemiological research. In the opposite direction, these same key terms coded in MedDRA representing adverse events, warnings, and other regulatory information could be converted into SNOMED CT so that the information is available in the patient's record to aid in clinical decision-making.
The two maps were created as part of a project involving SNOMED International and ICH entitled WEB-RADR 2. Funded by the Innovative Medicines Initiative (IMI), a large-scale public-private partnership between the EU and the pharmaceutical industry association, EFPIA, IMI aims to boost biopharmaceutical innovation in Europe and to speed up the development of better and safer medicines for patients. With the creation of the maps from the WEB-RADR 2 project, both SNOMED International and ICH have committed to their ongoing use and maintenance extending past the conclusion of the project.
Mick Foy, Medicines and Healthcare products Regulatory Agency UK and Chair of the ICH MedDRA Management Committee said "This is an exciting development and an important milestone. Developing interoperability between SNOMED CT and MedDRA has been a long-standing ambition and will greatly enhance data collection for regulatory purposes and for drug safety research".
SNOMED International CEO, Don Sweete, welcomes the evolution of the organization's relationship with ICH. "It is exciting to see a long-term alliance borne from a collaborative project created to improve drug safety for patients and citizens. This agreement serves a joint commitment by two organizations dedicated to enabling health systems interoperability across regulatory and clinical continuums."
The Production version of the two maps is being made available to licensed SNOMED CT and MedDRA users on April 30, 2021 and will be based on the January 2021 version of SNOMED CT and the September 2020 version of MedDRA. It is planned that the maps will be released annually in April.
To access the maps:
- Licensed MedDRA users, visit the Downloads (https://www.meddra.org/user/login?page=%2Fsoftware-packages) page on the MedDRA website
- Licensed SNOMED CT users visit SNOMED International (https://www.snomed.org/snomed-ct/Use-SNOMED-CT/maps)
Visit SNOMED International or MedDRA's Maintenance and Support Services Organization (MSSO) for map release documents, including:
- MedDRA-SNOMED CT Mapping Conventions are available here (https://www.snomed.org/snomed-ct/Use-SNOMED-CT/maps) for SNOMED CT users and here (https://www.meddra.org/mapping) for MedDRA users.
- Criteria for accepting requests for additions or changes to SNOMED CT to MedDRA map and MedDRA to SNOMED CT map is available here (https://www.snomed.org/snomed-ct/Use-SNOMED-CT/maps) for SNOMED CT users and here (https://www.meddra.org/mapping) for MedDRA users.
- Map Change Request Tool (https://mapcr.meddra.org/) (Map CR) and Map CR User Guide (https://www.meddra.org/MapCR-User-Guide)
For more information on these maps and resources, please contact MedDRA MSSO) or SNOMED International).
About SNOMED International:
SNOMED International is a not-for-profit organization that owns and develops SNOMED CT, the world's most comprehensive healthcare terminology product. We play an essential role in improving the health of humankind by determining standards for a codified language that represents groups of clinical terms. This enables healthcare information to be exchanged globally for the benefit of patients and other stakeholders. We are committed to the rigorous evolution of our products and services, to deliver continuous innovation for the global healthcare community. SNOMED International is the trading name of the International Health Terminology Standards Development Organisation.
To learn more about SNOMED International and SNOMED CT, visit www.snomed.org.
About the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Useand www.meddra.org.
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