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Welcome to MedDRA and the MSSO

   
 

MedDRA - the Medical Dictionary for Regulatory Activities - is a pragmatic, medically valid terminology with an emphasis on ease of use for data entry, retrieval, analysis, and display, as well as a suitable balance between sensitivity and specificity within the regulatory environment. It was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee.

MedDRA terminology applies to all phases of drug development, excluding animal toxicology. It also applies to the health effects and malfunction of devices.

Who should subscribe to MedDRA?

  • Pharmaceutical companies
  • CROs
  • Biotechnology companies
  • System developers
  • Device manufacturers 
  • Other support service
        organizations
  • Regulatory authorities

The MSSO - Maintenance and Support Services Organization - serves as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the biopharmaceutical industry and regulators. MedDRA subscribers submit proposed changes to the terminology. The MSSO includes a group of internationally based physicians who review all proposed subscriber changes and provide a timely response directly to the requesting subscriber.

JMO - Japanese Maintenance Organization - is a partner of the MSSO. They provide MedDRA support to companies headquartered in Japan as well as maintaining and distributing MedDRA/J. The JMO assists the MSSO in providing MedDRA-related information and services in Japan.

Freeze Date Reminder for
Version 12.0 Change Requests

1 December 2008
5:00 pm U.S. EST

Go to WebCR to submit your Change Requests

   
 
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