Understanding the Medical Dictionary for Regulatory Activities
Understanding the Medical Dictionary for Regulatory Activities
Overview
The Medical Dictionary for Regulatory Activities, or MedDRA is an international system of medical codes and terminology. It was created, and is currently managed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). MedDRA is used by a wide range of entities globally, such as government agencies during all phases of regulatory approval for pharmaceutical and biologic products, vaccines and drug devices. Using a common language, MedDRA enables the communication of concepts and terms (e.g., diseases, diagnoses, symptoms) to describe, document and monitor medical conditions and events.
MedDRA data hierarchy
The MedDRA dictionary is a hierarchy of health information comprised of 5 levels of classification, ranging from very general categories to very specific concepts and terms. At its highest level, are 27 unique System Organ Classes which broadly describe medical disorders by anatomical system (for example, Endocrine disorders, Gastrointestinal disorders, and so on) as well as other classifications such as medical and surgical procedures, social circumstances, and investigations. Each of the subsequent levels in the MedDRA hierarchy, including High Level Group Terms, High Level Terms, Preferred Terms and Lowest Level terms describe medical concepts and terms using increasingly specific language. There are greater than 80,000 unique terms at the lowest level of the MedDRA hierarchy.
The graphic below represents a sample of concepts and terms distributed across the five levels of the MedDRA hierarchy for a single System Organ Class.
MedDRA use cases
As an extensive, standardized coding system there are a substantial number of applications for the MedDRA dictionary. MedDRA is used internationally by regulatory authorities to help document and communicate important medical data during approval processes such as clinical trials. For example, using MedDRA allows the consistent collection and documentation of data generated from multiple sources during clinical trials which is used to inform patients about possible side-effects associated with their prescription medications.
MedDRA is also widely used by pharmaceutical and biologic industries. By enabling a common language, MedDRA facilitates consistent analysis of clinical data, such as adverse events collected from multiple sources around the world, to support important activities such as monitoring vaccines and other drug safety. MedDRA also allows multiple organizations to accurately share data when collaborating in the development of new products, and supports academic entities in the research and reporting of drug and biologic product safety and efficacy.
MedDRA in Pega Foundation for Healthcare
Pega Foundation for Healthcare has implemented MedDRA's hierarchical data structure as a unique code set, and includes a search and display function in which the user may easily access MedDRA codes and terms.
The user accesses the MedDRA library through the Foundation's Code Management portal, and may either explore the various MedDRA levels by clicking through the hierarchy displayed on the screen, or may configure a simple search in the User Interface for codes and terms.
