MedDRA in Pharmacovigilance

MEdDRA is a clinically-validated international system that contains standardized terminology used by pharmaceutical companies and regulatory authorities. It relies on a hierarchical structure to organize information about drugs, terminologies and Adverse Drug events in a uniform manner from pre-marketing to post-marketing for entry of data, retrieval, and presentation.

It is a medical dictionary that was developed in response to the need for comprehensive communication of safety information that stakeholders may find useful in making decisions about drug therapy. MedDRA came into existence when it was found that the use of different medical terminologies during the drug development process made it difficult to cross reference and analyze the data. Conversion of data from one terminology to another was a time taking process and costly as well as data conversion also led to loss or distortion of data.

MedDRA contains a comprehensive list of all known medical terms, including both International Classification of Diseases-10th revision and Systemized Nomenclature of Medicine – Clinical Terms. It converts the reported terms in standardized medical terminology to create uniformity across its use. It also has many tools like free text search, data import, data export, and batch processing tools. MedDRA is used by over 95% of the world’s pharmaceutical companies.

MedDRA was developed by the International Conference on Harmonisation (ICH), of Technical Requirements for pharmaceuticals Medicinal Products for human use and it is updated regularly by the Maintenance and Support Services Organization (MSSO). MedDRA Version 24.1 is the latest version which was released on 1 September 2021.

MedDRA Vision: –

MedDRA is committed to improve safety of medicine, public health monitoring, data management, data analysis, and communication by supporting clinical trials with high-quality data, providing analysis for public health benefits, and enhancing patient care. 

MedDRA vision is to- 

  • Eliminate the need to convert data from one terminology to another by preventing data loss and data distortion.
  • Improve the quality and timeline of data availability for effective analysis, sharing and decision making.
  • Facilitate the electronic exchange of drug data.

Use of MedDRA in Pharmacovigilance: –

Pharmacovigilance has come to rely heavily on the use of MedDRA because it makes communication easier between different healthcare professionals and agencies like the FDA, EMA, and NICE. Therefore, MedDRA is designed for use in drug registration, documentation, and safety monitoring at all stages of the development cycle (i.e., from clinical trials to post-marketing surveillance). Now this software used by pharmacovigilance professionals which helps them to import MedDRA terms into their systems according to the requirements of their jurisdiction. MedDRA is essential for both patient safety and pharmaceutical innovation. MedDRA system can be used in order to detect possible new safety concerns with regards to the drug being studied