This blog includes:
- A fundamental overview of MedDRA, its application as a dictionary/library.
- Uncovering lesser-known facts and realities about MedDRA.
Table of Contents:
Overview
As widely acknowledged, MedDRA stands out as a leading medical dictionary in the market, overshadowing its few competitors. Its popularity in regulatory activities stems from its precise terminology and hierarchical structure, making it easily comprehensible and accessible to users of all levels.
Specifically designed for coding adverse events and medical conditions, MedDRA’s widespread adoption by regulatory bodies and pharmaceutical companies further solidifies its prominence in the field.
Facts are not static; they evolve over time, especially in fields like technology. Let’s explore the evolving facts of MedDRA.
MedDRA: Uncovering Lesser-Known Facts
- MedDRA developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), hence trademark by International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). (Click here to learn more about ICH guidelines).
- MedDRA is commonly used in the EU, US, and Japan as well as other countries/regions that are ICH Observers (e.g. Canada and Switzerland).
- MedDRA was originally conceived in 1990 and gained formal regulation under Swiss law on October 23, 2015.
- MedDRA is developed in specific pharmaceuticals for human use to have highly specific medical terminologies.
- MedDRA developed in specific pharmaceuticals for human use.
- MedDRA served in 14 languages till date.
- Maintained by MSSO (MedDRA Maintenance and Support Services Organization), as MHRA, Health Canada and WHO as observer.
- MedDRA receives updates twice a year by MSSO, typically during spring and autumn. Significant modifications occur in the spring updates, whereas minor adjustments are made during the autumn updates.
- Currently over 700 device specific terms available in MedDRA (but not considered a primary dictionary for device reporting).
- MedDRA is an important tool for product evaluation, monitoring, communication, electronic records exchange and oversight.
- MedDRA is not a
- Contrary to common misconception, MedDRA is not a drug dictionary.
- Derivation device nomenclature.
- Allow for the inclusion of adjectives, such as those used to describe disease severity or frequency, in its derivations.
- Severity descriptors.
- Equipment, device diagnostic product dictionary.
- Patient demographic terms descriptor.
- Determining numeric value.
- MedDRA used for regulatory activities from pre-marketing to post-marketing but not for pre-clinical testing.
- MedDRA used in various activities such as,
- Individual Case Safety Reports and Safety Summaries.
- Clinical Study Reports.
- Investigators’ Brochures.
- Core Company Safety Information.
- Marketing Applications.
- Publications.
- Prescribing Information.
- Advertising.
- Regulatory Authority and Industry Databases.
- Each MedDRA term assigned an 8-digit numeric code starts with “1“.
- The numeric code in MedDRA remains consistent across all revisions, releases, and languages. It serves as a permanent and stable identifier.
- Recording adverse events and baseline medical history in clinical trials is crucial for analyzing and tabulating data, as well as for expediting the submission of adverse events.
- It offers the option of subscription basis for your use case beyond its regulatory activities.
- MedDRA has been mandatory in the EU for exchange of post-authorization safety data and many countries mandated using it for regulatory activities.
- Subscription grants access to MedDRA for one year.
- It was developed by the International Council for Harmonisation (ICH) to streamline regulatory processes.
- MedDRA is not designed to function as a dictionary for equipment, devices, or diagnostic products.
- It also does not serve as a product coding dictionary for various items, including devices and medicinal products.
- Fully collaborated with the World Health Organization (WHO) and fully implemented within the WHO safety database.
Conclusion
This blog reveals certain lesser-known facts about MedDRA, aiming to clarify any misunderstandings and provide helpful insights to those interested in learning more about it. While we’ve listed what we know, there may be some aspects we’ve overlooked.
Feel free to contribute any additional information or insights about MedDRA that we may have missed.
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