ICH announces new data exchange with SNOMED to promote drug safety

Regulatory NewsRegulatory News | 30 April 2021 |  By 

The International Council for Harmonization (ICH) announced on 29 April the release of its first set of data maps with SNOMED International that facilitates the exchange of adverse event reports and other important epidemiologic information between regulators and researchers.
This release of the maps is the first deliverable of an agreement between SNOMED International and ICH that aims to promote drug safety.

The ICH Medical Dictionary for Regulatory Activities (MedDRA) database is a standardized medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products. MedDRA is used for registration and safety monitoring of medical products before and after they are placed on the market.
SNOMED CT, owned and maintained by the nonprofit SNOMED, is a library of clinical terminology with over 350,000 concepts ranging across diagnoses and symptoms as well as lists of surgical, therapeutic and diagnostic procedures. ICH announced that the joint effort produced two independent maps, MedDRA to SNOMED CT and SNOMED CT to MedDRA. 
The MedDRA terms included in the maps include “frequently used and key pharmacovigilance MeDRA terms” derived from the European Medicines Agency and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA), according to the ICH announcement of the new data maps.
Pharmacovigilance terms coded in SNOMED CT in an electronic health record (EHR) are converted to MedDRA, facilitating adverse event reporting to regulatory authorities and for the purposes of conducting epidemiological research.
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.”
ICH said that the maps also contain a set of COVID-19 related terms to “capture important aspects of the pandemic.”
Both ICH and SNOMED officials announced their support for the agreement.
MHRA’s Mick Foy, 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 said “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 project is funded by the Innovative Medicines Initiative (IMI), a public private partnership between the EU and the European Federation of Pharmaceutical Industries and Associations. IMI aims to boost biopharmacual innovation in Europe and to speed the development of medicines for patients.
The two maps became available on 30 April 2021 to licensed SNOMED CT and MedDRA users.
ICH announcement on collaboration between MedDRA and SNOMED


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