The Medical Dictionary for Regulatory Activities (MedDRA) is a comprehensive and highly standardized medical terminology used to facilitate the sharing of regulatory information internationally for medical products. Here are some key aspects of MedDRA:
- Purpose: MedDRA is used for the registration, documentation, and safety monitoring of medical products both before and after a product has been authorized for market. It helps in the classification of adverse event information associated with the use of biopharmaceuticals and other medical products.
- Development and Management: MedDRA was developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The maintenance and development of MedDRA is managed by the MedDRA Maintenance and Support Services Organization (MSSO) in collaboration with the European Medicines Agency (EMA) and other regulatory bodies.
- Structure: MedDRA’s hierarchical structure includes several levels of specificity, enabling it to capture a wide range of medical information:
- Lowest Level Terms (LLTs): Most detailed level, representing unique symptoms, signs, diseases, diagnoses, etc.
- Preferred Terms (PTs): Aggregate similar LLTs.
- High Level Terms (HLTs): Further group PTs.
- High Level Group Terms (HLGTs): Assemble related HLTs.
- System Organ Class (SOC): Highest level of the hierarchy, representing a system or organ class.
- Uses: MedDRA is utilized in various regulatory activities, including:
- Reporting and monitoring adverse drug reactions.
- Supporting clinical trials by categorizing patient data.
- Assisting in the evaluation and authorization of drugs.
- Language and International Use: MedDRA is available in multiple languages, facilitating its use as an international standard. This broadens its applicability across different countries and regulatory environments.
- Subscription-Based Access: Access to MedDRA is typically subscription-based, intended for use by regulatory authorities, pharmaceutical companies, and other organizations involved in health care product regulation.
- Continuous Updates: MedDRA is regularly updated to include new medical information and respond to the evolving needs of its users.
MedDRA plays a crucial role in the standardization and harmonization of medical terminology in the regulatory process, thereby contributing to the safety and efficacy of medical products on a global scale. It’s an essential tool for drug regulation, pharmacovigilance, and ensuring patient safety.