Understanding MedDRA Use in Across Product Life-cycle

This blog features:

1. Where MedDRA is used across the pharmaceutical industry as a whole from testing to submisison
2. Key areas explained by point
3. Information that is generally outside the scope of MedDRA

Introduction

MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology widely used throughout the pharmaceutical industry for human use, from drug development and clinical research to post-marketing pharmacovigilance.

For professionals working in pharmacovigilance, particularly ICSR case processing, understanding where MedDRA is used and what information should be coded is an essential skill.

Areas Where MedDRA Is Used

The use of MedDRA can be broadly classified into three major areas:

1. Pharmaceutical Industry
2. Drug Development Lifecycle
3. Pharmacovigilance and Clinical Trial Activities

Where Is MedDRA Used in the Pharmaceutical Industry?

MedDRA is used in a wide range of regulatory, clinical, and pharmacovigilance activities, including:

• Regulatory authority and industry safety databases
• Individual Case Safety Reports (ICSRs)
• Safety summaries and aggregate safety reports
• Clinical study reports
• Investigators’ brochures
• Core company safety information
• Marketing applications
• Scientific and medical publications
• Prescribing information
• Advertising and promotional materials

Its standardized terminology helps pharmaceutical companies and regulatory authorities consistently communicate medical information across different systems and stages of the product lifecycle.

Where Is MedDRA Used Across the Drug Development Lifecycle?

MedDRA can be used throughout the development and lifecycle of a medicinal product, including:

1. Preclinical Testing – Medical concepts and safety findings generated during non-clinical development may be represented using standardized terminology where applicable.
2. Clinical Phase I – Safety information and adverse events from first-in-human and early clinical studies.
3. Clinical Phase II – Safety and medical information generated during dose-ranging and therapeutic studies.
4. Clinical Phase III – Adverse events and other safety information from larger, confirmatory clinical trials.
5. Marketed Product / Phase IV – Post-marketing safety surveillance, including spontaneous reports, literature cases, and other pharmacovigilance data

Therefore, MedDRA is not limited to post-marketing pharmacovigilance. It can support the standardized collection, classification, analysis, and communication of medical information throughout the product lifecycle.

Where Is MedDRA Coding Used in Pharmacovigilance Clinical Trials?

For professionals involved in ICSR processing, MedDRA coding can be required for much more than the reported adverse event.

1. Adverse Event/Reaction Coding

Coding the reported adverse event or reaction is one of the primary applications of MedDRA in pharmacovigilance.

2. Indications

The medical condition for which a medicinal product was used may require MedDRA coding.

3. Patient Medical History

Relevant medical history may include:

• Previous or historical conditions
• Current medical conditions
• Social circumstances
• Relevant procedures

4. Laboratory and Investigation Findings

Relevant medical findings associated with laboratory tests or investigations may be coded when appropriate. However, numerical laboratory values themselves are not MedDRA terms.

5. Medical and Surgical Procedures

Relevant medical or surgical procedures may involve MedDRA coding depending on the context and applicable coding conventions.

6. Medical, Social, and Family History

Relevant medical concepts contained in a patient’s medical, social, or family history may require coding.

7. Medication Errors

Medication errors may involve multiple concepts that need to be considered separately, including the error and any resulting clinical consequences.

8. Device-Related Issues

MedDRA may be used to represent relevant medical concepts and clinical consequences associated with medical device use. However, MedDRA is not a device dictionary.

9. Product Use Issues

Certain medical concepts associated with product-use problems may require MedDRA coding.

10. Pharmacogenetic Concepts

Relevant pharmacogenetic or pharmacogenomic medical concepts may be represented using MedDRA where applicable.

11. Toxicological Events

Toxicological conditions and clinically relevant manifestations may require MedDRA coding.

12. Standardised MedDRA Queries

Standardised MedDRA Queries (SMQs) group related MedDRA terms and can support safety-data retrieval, analysis, and signal detection.

What Is Generally Outside the Scope of MedDRA?

Not every piece of information in a pharmacovigilance case should be coded using MedDRA.

Examples include:

1. Patient demographic information – such as age and sex.
2. Frequency qualifiers – such as frequent, rare, or occasional.
3. Numerical laboratory values – the actual numerical result is not a MedDRA term.
4. Clinical trial study-design terminology – certain methodological and study-design information is outside the scope of MedDRA.
5. Severity descriptions – terms such as mild, moderate, and severe generally describe severity rather than the medical condition itself.
6. Device or equipment identification – MedDRA is not intended to function as a medical-device, equipment, or diagnostic-product dictionary.
7. Non-medical information – information that does not represent a relevant medical concept should not automatically be forced into MedDRA.

Key Takeaways

• MedDRA is used across the medicinal product lifecycle, from drug development through post-marketing surveillance.
• Its application extends beyond adverse-event coding.
• Good MedDRA coding requires understanding the clinical concept, context, terminology hierarchy, and applicable coding conventions, rather than simply finding a similar-looking term in the dictionary.
• Consistent coding supports better safety-data analysis, communication, signal detection, and regulatory reporting.

Conclusion

MedDRA is an integral part of modern pharmacovigilance and clinical safety processes. Its use begins during drug development and continues through the marketed-product lifecycle.

For pharmacovigilance professionals, developing strong MedDRA coding skills is therefore essential. Effective coding is not simply about finding a term in the dictionary—it requires understanding what should be coded, what should not be coded, and how the medical information should be represented consistently within the applicable MedDRA framework.

For anyone beginning a career in pharmacovigilance, gaining practical exposure to MedDRA alongside theoretical knowledge can be particularly valuable in developing confidence and consistency in real-world case processing.