MedDRA is a globally standardized medical terminology used to code, classify, and analyze safety data related to medicines and healthcare products. It is widely accepted and used by regulatory authorities and the pharmaceutical industry to maintain uniformity and accuracy in adverse event reporting.
What is MedDRA?
MedDRA is a structured medical terminology that helps convert real-world patient and doctor information into standard regulatory terms. It supports accurate reporting of:
- Adverse Drug Reactions (ADRs)
- Adverse Events (AEs)
- Signs and Symptoms
- Medical Conditions and Diagnoses
- Indications (reason for taking the drug)
- Medication Errors
- Product Quality Complaints
Medical and Surgical Procedures
This standardization makes sure that the same medical event is reported and understood in the same way across different countries and databases.
Why is MedDRA Important in Pharmacovigilance?
In real life, the same condition can be written in many ways.
For example:
“Stomach pain”
“Abdominal pain”
“Tummy ache”
“Pain in abdomen”
If these are entered differently, it becomes difficult to analyze safety data.
Example of MedDRA Coding
Patient reports: “Stomach pain after taking the medicine.”
MedDRA coding can be:
LLT: Stomach pain
PT: Abdominal pain
HLT: Abdominal pain and discomfort
HLGT: Gastrointestinal signs and symptoms
SOC: Gastrointestinal disorders
This is how MedDRA converts the patient’s language into a globally accepted coding structure.
MedDRA solves this by providing one common language.
MedDRA helps in:
Consistent case processing in ICSR reporting
Correct medical coding and medical review
Better signal detection (finding new safety risks)
Accurate trend analysis and reporting
Regulatory compliance and audit readiness
Data sharing across global safety systems
That is why MedDRA is essential for regulatory submissions to authorities like FDA, EMA, MHRA, PMDA, and many more.
MedDRA Hierarchy (5 Levels)
MedDRA follows a 5-level hierarchy, from broad categories to very specific terms.
This structure helps in both detailed reporting and high-level analysis.
SOC – System Organ Class (Highest level)
This is the broadest category based on body system or medical area.
Example: Gastrointestinal disorders
HLGT – High Level Group Term
Groups related medical conditions together.
Example: Gastrointestinal signs and symptom
HLT – High Level Term
A more specific grouping under HLGT.
Example: Abdominal pain and discomfort
PT – Preferred Term
This is the standard term mainly used in ICSRs and safety reports.
Example: Abdominal pain
LLT – Lowest Level Term
This includes very specific words and synonyms, including patient-friendly terms.
Example: Stomach ache, Pain in abdomen
Where is MedDRA Used?
MedDRA is used in many areas of the pharmaceutical and healthcare industry, such as:
•Individual Case Safety Reports (ICSRs)
• Clinical trials safety reporting
• Periodic safety reports like PSUR/PBRER
• Signal detection and risk management
• Safety databases like Argus, ArisG, Veeva Vault Safety
• Regulatory submissions and inspections
Key Takeaway
MedDRA is not just a dictionary.
It is a critical tool for drug safety, helping professionals report adverse events correctly, analyze safety data efficiently, and ensure global compliance.
When safety data is coded properly using MedDRA, it supports:
- Better patient safety
- Faster identification of drug risks
- Stronger regulatory reporting
- Improved healthcare outcomes
MBH/PS