MedDRA is the Medical Dictionary for Regulatory Activities. This is an excellent dictionary used for coding purposes and therefore valuable to learn for people aspiring to work in coding as well as in the Pharmacovigilance domain. MedDRA is a collection of terminologies for coding and communication. It contains terms for signs, symptoms, diseases, syndromes, diagnoses, indications, investigations, medication errors, some quality terms, procedures, and some terms for medical and social history. MedDRA has a huge terminology bank that covers drugs, advanced therapies (e.g., biologics), and some device information. 

It has five levels, and below is the hierarchical structure:

• System organ classes (SOCs)
• Higher level group terms (HLGTs)
• Higher level terms (HLTs)
• Preferred terms (PTs)
• Lowest level terms (LLTs)

The most common levels used in Pharmacovigilance practice are the LLT and PT levels. These terms are all medical terms compared to reporters’ terms (“verbatim terms”) which may or may not be medical. The most specific terms are found in the LLT (lower level terms), and most high-level, non-specific terms are found in the SOC level. MedDRA use is required by Europe for pharmacovigilance reporting and is recommended by the US FDA for use. Almost all companies use MedDRA for regulatory reporting because of its advantages over other dictionaries.

MedDRA dictionary can be imported within the Pharmacovigilance database, and it can also be archived as a browser. The MedDRA Support Service Organization (MSSO) supplies a browser to subscribers, and one needs this subscription to access the dictionary.

MedDRA coding is an indispensable need in the pharmacovigilance department. It is a skill, and one needs to understand the tricky situation, different conditions, the entire case, and the art of appropriate coding, for which Training is vital.