MEDRA CODING

MEDRA 

 Medical Dictionary for Regulatory Activities. This is clinically validated medical terminology used by regular  authorities in pharmaceutical industry during the process of regulations. From the pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. MEDRA was developed by International Conference on Harmonization (ICH) used for Pharmaceuticals of human use.

Organization of MEDRA dictionary:

   The MEDRA dictionary was organized by System Organ Class (SOC).Medra is divided into high level and low level terms. The Medra dictionary includes Standardized Medra  Queries (SMQs).Grouping of terms in SMQs are used for medical condition.

            Individual cases are usually coded to enter data for  most specific (LLT) level  The higher levels (HLT, HLGT and SOC) as well as SMQ are used for searching for organization and subtotaling of outputs . outputs of counts are usually provided at the PT level. for more information in medical go through  

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Maintenance for MEDRA:

·         MEDRA is managed by the MSSO (Maintenance and Support Services Organization).

·         The MSSO updates MEDRA according to request of existing one.

·         The decisions are taken by international medical officers. Based on   terminology grouping categories.

·         Updated  version of MEDRA is released twice in a year by MSSO.

·         In march main annual release changes is done in HLT,LLT and PT.

·         The September release typically changes contains only at the LLT and PT level.

WHO and MEDRA:

• Medra is of two one  is implanted by WHO’s Global Safety Database.

• Second one by WHO Uppsala Monitoring Centre (UMC) receives most of its ICSRs coded in MEDRA

TOOLS  of  MEDRA:

•          MedDRA comes with software tools
•        Browsers (Desktop and Web-based) to review and search the terminology

ACESS TO MEDRA:

  ·         Medra  is free to regulatory authorities, academics, healthcare providers.

• ·         Commercial organizations pay annual fee based on revenue/turnover.
• ·         Subscription rates have been reduced or remained unchanged for the past 6 years.
• ·         Special licenses for access by low revenue companies: – EMA has this in place; FDA, under development.
• ·         Medra  Board is currently exploring other models to help facilitate MedDRA’s use.

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