What is the relationship between MedDRA and EudraVigilance?
MedDRA is the international medical terminology (Medical Dictionary for Regulatory Activities) developed under the auspices of the ICH. As the terminology requires to be constantly updated, a Maintenance and Support Service Organisation (MSSO) was appointed under the umbrella of the ICH to maintain and distribute the terminology, on license, to users in industry and regulatory agencies. In Japan, the MedDRA maintenance is taken care of by the Japanese Maintenance Organization (JMO). The activities of the MedDRA MSSO are overseen by the MedDRA Management Board composed of the six ICH parties, the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK , Health Canada, The World Health Organization, and chaired by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). In accordance with Community legislation and guidelines, MedDRA should be used by all stakeholders for the coding of medical information in the frame of the electronic transmissi
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- What is the relationship between MedDRA and EudraVigilance?
