Understanding MedDRA: A Pillar of Global Pharmacovigilance

What is MedDRA?

MedDRA (Medical Dictionary for Regulatory Activities) is a clinically validated international medical terminology used by regulatory authorities and the biopharmaceutical industry. It standardizes the coding of adverse events in clinical study reports and pharmacovigilance databases, ensuring efficient data entry, retrieval, evaluation, and presentation throughout the regulatory process.

Key Requirements for MedDRA Development:

• International Applicability: Supported and used by both industry and regulators.
• Broader Coverage of Health Data: Ensures comprehensive data capture.
• Increased Specificity: Provides detailed and precise coding.
• Structured for Analysis and Presentation: Facilitates clear and accurate data reporting.
• Centrally and Externally Maintained: Managed by the Maintenance and Support Services Organization (MSSO).
• IT Compatibility: Works seamlessly with various IT systems and tools.

Rationale for MedDRA:

• Global Standardization and Harmonization: Ensures uniformity across regulatory agencies and multinational pharmaceutical companies.
• Necessary Throughout Product Lifecycle: Used from pre-marketing to post-marketing stages.
• Essential for Electronic Data Transfer: Enables efficient and accurate data exchange.
• Avoids Translation Distortions and Errors: Maintains data integrity across different languages and regions.
• Supports Multiple Medical Product Areas: Provides a comprehensive classification for diverse clinical information.

Scope of MedDRA:

• Adverse Event Terms: Standardizes the reporting of adverse events.
• Therapeutic Indications: Codes indications for therapeutic use.
• Medical and Surgical History: Captures patient history accurately.
• Laboratory Data: Ensures consistent coding of lab results.

Who Uses MedDRA?

MedDRA is universally used by regulatory authorities and the pharmaceutical industry worldwide.

Update Frequency:

MedDRA is updated bi-annually, with the latest version being 27.0, released in March 2024.

Maintenance:

MedDRA is maintained by the MSSO, appointed by the ICH assembly, ensuring it remains hierarchical, multiaxial, multilingual, and regularly updated.

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