Today the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are announcing a new collaboration to enhance registry and sharing of regulatory information on medical products worldwide.
The collaboration aims to establish a unified language that streamlines global regulatory decision-making concerning the safety and efficacy of medical products, while offering vital insights into the scope, causes and consequences of diseases and mortality, worldwide.
By connecting the WHO International Classification of Diseases (ICD-11) with the ICH Medical Dictionary for Regulatory Activities (MedDRA), this common language will enhance the analysis of adverse events and outcomes, such as insurance claims’ databases, mortality and morbidity statistics, clinical trials, and observational studies.
“Our collaboration with ICH’s MedDRA facilitates the regulation and safety of medical products in a larger number of countries, benefiting more people,” said Dr Robert Jakob, WHO Team Lead, Classifications and Terminologies Unit. “More significantly, it paves the way for enhancing medical treatment and patient safety, and also aids in the overall improvement of health policies.”
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. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorised for use.
“ICH is very excited to work with WHO on this project which will enhance pharmacovigilance signal detection across even larger volumes of data and the identification of important public health issues,” said Mr Mick Foy, MHRA, UK and Chair of the ICH MedDRA Management Committee.
ICD-11, the International Classification of Diseases, is the global standard for recording, reporting, analyzing, and comparing causes of illness and death. It helps countries identify and prioritize key health issues, enabling the development of effective public health policies, impact measurement, resource allocation, treatment improvement, prevention efforts, and clinical recording.
Resources on the linkages will be available publicly from the WHO website under an ICD license (CC-BY-ND) and made available free of charge, and also from ICH to MedDRA subscribers.