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What is MedDRA

What is MedDRA. MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology used in pharmacovigilance and clinical trials. It is maintained by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and is used by regulatory agencies and the pharmaceutical industry worldwide.

MedDRA provides a standardized and consistent way of identifying, coding, and describing adverse events, medical conditions, and other related information. It is used to:

  1. Facilitate the exchange of information between regulatory agencies and the pharmaceutical industry.
  2. Standardize the reporting and analysis of adverse events in clinical trials and post-marketing surveillance.
  3. Enhance the comparability and consistency of adverse event data across different products and studies.
  4. Support the conduct of systematic literature reviews and other forms of safety surveillance.

MedDRA is regularly updated to reflect new medical knowledge and to ensure that it remains up-to-date and comprehensive. It is widely used in pharmacovigilance and clinical trials, and plays a critical role in ensuring the consistency, accuracy, and comparability of adverse event data.

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