Main Idea:
MedDRA was developed in response to a need recognized by ICH to standardize the medical terminology used internationally to discuss the regulation of medical products. This terminology is used to share information regarding medical product registration, documentation and safety monitoring of human medical products both before and after a medical product has been authorized for sale.
Functions:
MedDRA includes terminology for symptoms, signs, diseases and diagnoses. In addition, it contains the names of investigations (e.g. Liver function analyses, metabolism tests), sites (e.g. application site reactions, implant site reactions and injection site reactions), therapeutic indications, surgical and medical procedures and medical, social and family history terms.
1)The MedDRA Maintenance and Support Services Organization (MSS0) keeps, maintains and distributes MedDRA information. MedDRA users request additions and deletions to the terminology through a process described on the MSSO homepage. Updated information is regularly sent to subscribers via CD-ROM.
2)MedDRA terminology will be used to express medical concepts in certain Modules of the Common Technical Document.
3)By providing one consistent source of medical terminology, MedDRA improves the effectiveness of medical product regulation worldwide. Regulatory authorities such as the TPD and pharmaceutical or biological manufacturers are then able to use consistent terms to classify information (i.e. the same term is applied in similar situations).
4)It will provide significant improvement over current terminologies in comprehensiveness and specificity. The data retrieval capabilities of the terminology will facilitate and simplify regulatory processes.
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