Medical Dictionary for Regulatory Activities (MedDRA) is a clinically-validated international dictionary of medical terminology. It is used for the classification of adverse event information associated with the use of pharmaceuticals and medical devices.
MedDRA is also a sophisticated thesaurus of highly specific, standardized medical terms that facilitates the sharing of regulatory information for pharmaceutical products. It is used for registration, documentation, and safety monitoring of medicinal products.
MedDRA is considered a standard in the biopharmaceutical industry, and it can be used before and after the products’ authorization. It also assists researchers and healthcare professionals for more accurate data entry, retrieval, evaluation, and presentation.
Its use is essential in the development and regulation of pharmaceuticals, vaccines, biologics, and medical devices. Therefore, its primary beneficiaries are pharmaceutical companies, CROs, and even routine healthcare professionals.
MedDRA was developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in the late 1990s. Its founding members are the leading regulatory agencies and health associations across the world, such as the EU, FDA, EFPIA, WHO, JPMA, etc.
Today, it is regulated by the ICH MedDRA Management Committee that oversees the operations of the MedDRA Maintenance and Support Services Organization (MSSO). MSSO updates MedDRA and distributes it through sets of extended ASCII delimited files.
The system is continually being enhanced to meet the needs of evolving medical research. MSSO oversees a vast network of users on its forum that update each other on the best practices on MedDRA use.
Who Uses MedDRA?
The dictionary is mastered in English and translated initially to Japanese. Today, MedDRA is a multilingual platform, as it has been translated into Chinese, German, French, Korean, Italian, Hungarian, Czech, Dutch, Portuguese (including Brazilian dialect), Russian, and Spanish.
Multiple language options assist users in operating MedDRA in their native language, while the primary medical term remains unaltered in the form of a code. This type of interoperability makes this technology the most desirable in clinical trials.
How Does MedDRA Work?
Adverse event data is MedDRA-coded by trained professionals from medical histories, clinical trial data, or other applicable sources that have been collected by healthcare practitioners.
Each MedDRA term is displayed as an eight-digit numerical code. The codes are structured in a sophisticated hierarchy, which is essential for flexible data retrieval and transparent presentation of data. Moreover, distinct hierarchies make it available to retrieve data by group according to specific criteria. MedDRA is used for analyzing individual medical events, or it can be queried for the retrieval of more generalized information that relates to a particular organ group.
Its hierarchy has five levels:
- System Organ Class (SOC),
- High-Level Group Terms (HLGT),
- High-Level Terms (HLT),
- Preferred Terms (PT),
- Lowest Level Terms (LLT).
Each level has its way of specificity, with LLT being the most specific term. The Standardized MedDRA Queries (SMQs) are groups of terms that facilitate quick search.
Today, MedDRA is an integral part of the ICH e-submission standards: eCTD (ICH M8) and ICSRs (ICH E2B).