The World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) collaborate to enhance the registry and sharing of regulatory information on medical products worldwide.
The collaboration will help establish a unified language that streamlines global regulatory decision-making involving the safety and efficacy of medical products while offering insights into the scope, causes and consequences of diseases and mortality worldwide, the WHO said.
“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,” the United Nations health agency added.
Dr Robert Jakob, WHO Team Lead, Classifications and Terminologies Unit, said, the collaboration paves the way for enhancing medical treatment and patient safety. Also, it aids in the overall improvement of health policies.
MedDRA, the Medical Dictionary for Regulatory Activities, is a 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 before and after a product has been authorised.
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, the note said.
“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 Mick Foy, MHRA, UK and Chair of the ICH MedDRA Management Committee.