A new connection announced between the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) will spur development of a common language and registry of medical product regulatory information globally.
The pair have united the WHO International Classification of Diseases (ICD-11) with the ICH Medical Dictionary for Regulatory Activities (MedDRA), allowing for greater analysis of trouble events and outcomes, delving of insurance claims databases, mortality and morbidity statistics, clinical trial, observational studies and more. Together, their ultimate goal is a unified, streamlined language to empower global regulatory decision-making for medical products.
“Our collaboration with ICH’s MedDRA facilitates the regulation and safety of medical products in a larger number of countries, benefiting more people,” Dr. Robert Jakob, WHO Team Lead, Classifications and Terminologies Unit, said. “More significantly, it paves the way for enhancing medical treatment and patient safety, and also aids in the overall improvement of health policies.”
ICD-11 is a global standard for recording, reporting, analyzing and comparing causes of illness and death. Ideally, it helps countries identify and prioritize critical health issues, including the development of effective public health policies, measurement of impact, allocating resources, improving treatments, prevention efforts and clinical recording. On the other hand, MedDRA is a highly specific set of medical terminology developed by ICH for regulatory information on medical products used by humans. It’s used for registration, documentation and safety monitoring of those products before and after authorization.
“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,” Mick Foy, MHRA, UK and chair of the ICH MedDRA Management Committee, said.
This collaboration will yield free, publicly available resources on WHO’s website, as well as directly from ICH to MedDRA subscribers.