MedDRA (Medical Dictionary for Regulatory Activities)
What is the Medical Dictionary for Regulatory Activities (MedDRA)?
MedDRA is a standardized medical terminology developed to aid the international sharing of regulatory information on medical products such as vaccines, pharmaceuticals, and drug-device combination products. It is used for the registration, documentation, and safety monitoring of medical products before and while they are available for market use.
MedDRA is maintained, developed, and distributed by the Maintenance and Support Services Organization (MSSO), which is contracted by ICH and overseen by the MedDRA Management Committee. It is continually updated to meet the evolving needs of regulators and is fully implemented in the WHO global safety database.
MedDRA terminology is free for all regulators, healthcare providers, and academics, regardless of their location.
Why is MedDRA important for healthcare?
MedDRA is critical to standardized regulatory control over medical products such as vaccines, pharmaceuticals, and drug-device combinations. With its use in the registration, documentation, and safety monitoring of medical products, any regulatory authority or healthcare professional can easily evaluate all the regulatory information on a medical product.
Furthermore, MedDRA is used when reporting adverse events, which allows regulatory authorities to respond to these events, manufacturers to address them, and healthcare providers to be aware of them.