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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 10
First page : ( 4751) Last page : ( 4754)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00866.1

MedDRA (Medical Dictionary for Regulatory Activities)

Jaasu Nukalapati Mishma*, Dr. Kamaraj Raju, Seetharaman R.

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-6030203, Kanchipuram, Tamilnadu, India

*Corresponding Author E-mail: mishmajaasu@gmail.com

Online published on 20 December, 2018.

Abstract

MedDRA is improved by ICH (international conference on hormonisation). It is defined as clinically validated international terminology for medical products used by regulatory authorities. It is a dictionary of adverse events. It is classified into 5 levels totaling over 81, 000 terms. When compared with the world health organization-adverse reaction terminology (WHO-ART) MedDRA is much larger dictionary. The main purpose of MedDRA is to provide uniform consistent, reliable methodology. Between the process of premarketing to the post marketing MedDRA terminologies are used. ICH recognized the different terminologies at different stages to make easy to analyze data. MedDRA was developed based on UK earlier version drug regulatory agency. For monitoring, product evaluation, electronic records exchange, communication, and oversight Medical dictionary for regulatory activities (MedDRA) became an important tool. In the MedDRA terms for diseases, signs, indications, medication errors, investigations, some terms for social medical history and some quality term procedures are included. In MedDRA drugs, advanced therapies and some device information was covered. To handle the information regarding clinical about biologics, pharmaceuticals, drug-device combinations and vaccines for entire life span of products MedDRA was created. Hardware or software are not required for MedDRA. specific functional system or version of a functional system is not required. Finally, MedDRA went live in early 1999.

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Keywords

MedDRA, medical terminology, adverse events, regulatory, biopharmaceutical industry.

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