Hello Guys,
In this article we will see some basics of MedDRA (Medical Dictionary for Regulatory Activities).
MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry.
MedDRA hierarchy
The structure of MedDRA is very logical. There are five levels to the MedDRA hierarchy, arranged from very specific to very general.
LLT: The most specific level, called “Lowest Level Terms” (LLTs). There are more than 80,000 terms which parallel how information is communicated.
PT: Each member of the next level, “Preferred Terms” (PTs), is a distinct descriptor (single medical concept) for a symptom, sign, disease diagnosis, therapeutic indication, investigation, surgical or medical procedure, and medical social or family history characteristic. Each LLT is linked to only one PT. Each PT has at least one LLT (itself) as well as synonyms and lexical variants (e.g., abbreviations, different word order).
HLT: Related PTs are grouped together into “High Level Terms” (HLTs) based upon anatomy, pathology, physiology, etiology or function.
HLGT: HLTs, related to each other by anatomy, pathology, physiology, etiology or function, are in turn linked to “High Level Group Terms” (HLGTs).
SOC: Finally, HLGTs are grouped into “System Organ Classes” (SOCs) which are groupings by etiology (e.g. Infections and infestations), manifestation site (e.g. Gastrointestinal disorders) or purpose (e.g. Surgical and medical procedures). In addition, there is a SOC to contain issues pertaining to products and one to contain social circumstances.
MedDRA update
The MSSO release updated MedDRA versions twice a year – in March and September. The English translation is released on the 1st of March and September and all other translations are released on the 15th.
Latest version of MedDRA
The current MedDRA version is 24.1
Total SOCs in MedDRA
Currently there are 27 SOCs in MedDRA.
SMQs (Standardised MedDRA Queries)
Standardised MedDRA Queries (SMQs) are tools developed to facilitate retrieval of MedDRA-coded data as a first step in investigating drug safety issues in pharmacovigilance and clinical development.
SMQs are validated, pre-determined sets of MedDRA terms grouped together after extensive review, testing, analysis, and expert discussion.
SMQs are a unique feature of MedDRA and provide a strong tool to support safety analysis and reporting.
The SMQ topics are intended to address the important pharmacovigilance topics needed by regulatory and industry users.
The SMQs are maintained with each release of MedDRA by the MSSO.
Currently, over 100 SMQs have been created. Additional SMQs are created as the need arises. The following are a small sampling of SMQs that are available to users today:
- Anaphylactic reaction
- Central nervous system vascular disorders
- Convulsions
- COVID-19
- Depression and suicide/self-injury
- Drug abuse, dependence and withdrawal
- Hyperglycaemia/new onset diabetes mellitus
- Hypersensitivity
- Ischaemic heart disease
- Lack of efficacy/effect
- Medication errors
- Severe cutaneous adverse reactions
MSSO (Maintenance and Support Services Organization)
Under the oversight of the ICH MedDRA Management Committee, the key function of the MSSO is to maintain, distribute, and support MedDRA on behalf of MedDRA users. The MSSO staff includes:
- Physicians and support personnel that participate in the review of proposed changes submitted by MedDRA users
- Highly skilled, multi-lingual (Chinese, English, French, German, Korean, Spanish) MedDRA trainers with industry experience and in depth knowledge of regulatory reporting requirements
- Dedicated, full-time quality assurance personnel to ensure compliance to the MSSO’s ISO 9001:2015 certification
- IT staff to develop and maintain software tools for MedDRA users
- Project Management to provide oversight and direction
The MedDRA MSSO staff ensures that daily operational processes and medical reviews of the MedDRA terminology are performed utilising the highest quality standards in the industry.
The MSSO international team possesses a wide range of background experiences in the Biopharmaceutical, Regulatory, and IT industries. The MSSO also has a partnership with the Japanese Maintenance Organization.
If you have any query, please contact at pvdrugsafetyinfo@gmail.com.
Regards,
PV Drug Safety