This blog covers the following topics:
- Overview and purpose of MedDRA.
- A more in-depth discussion on the true vision and mission of MedDRA, accompanied by a detailed table.
Table of Contents:
Overview
MedDRA stands for Medical Dictionary for Regulatory Activities. It is a standardized medical terminology developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
📢 Click here to explore more in details and nuances of ICH Guildeines.
MedDRA is widely used in the field of pharmacovigilance and drug safety to facilitate the coding, classification, and analysis of adverse event data associated with medical products.
Purpose
The primary purpose of MedDRA is to provide a common language for the accurate and consistent reporting of adverse events (also known as adverse drug reactions or ADRs) observed during clinical trials and post-marketing surveillance of pharmaceutical products.
Adverse events can range from mild side effects to severe and life-threatening reactions.
The Hierarchy
MedDRA is structured hierarchical system of terms organized into a multi-axial structure.
The terms arranged in a standardized manner, and each term assigned a unique code, making it easier to communicate and exchange data relate to adverse events across different regions and regulatory authorities.
“MedDRA: where precision meets patient safety, creating a vital bridge between adverse events and actionable insights for a healthier world.”
Vision and mission
Harmonisation for Better Health:
Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. Harmonisation achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side.
Key to the success of this process is the commitment of the ICH regulators to implement the final Guidelines.
With ICH’s establishment as an international non-profit Association under Swiss law on October 23, 2015, ICH’s mission has been embodied in its Articles of Association.
The below table summaries the key points of MedDRA’s vision and mission in a clear and organized manner.
Table: 1
| Vision | Mission |
|---|---|
| Enhance global healthcare safety | Standardise medical terminology for regulatory use |
| Removal and addition of data to prevent loss and distortion | Make recommendations to achieve greater harmonization in interpretation |
| Effective analysis of data | Maintain a forum for addressing issues between regulatory authorities and pharmaceutical companies |
| Improvement in ease, quality, analysis, and decision making | Monitor and update technical requirements |
| Consistency | Contribute to the protection of public health |
| Facilitate the electronic exchange (E2B) | Develop policy standards for MedDRA to ensure the sharing of regulatory information on medicinal products used by humans |
| Global healthcare data alignment | Foster transparency and data compatibility |
| Achieve greater harmonisation to ensure safety, efficacy and high quality of medicines |
Overall, ICH’s commitment to MedDRA enhances medical product regulation and safeguards public health on a global scale.
Closing thoughts
In conclusion, this blog aims to shed light on the vital aspects of MedDRA’s vision and mission, illustrating how this tool significantly enhances our pharmacovigilance processes. Its impact, however, extends far beyond pharmacovigilance, benefiting various sectors within the healthcare system and ensuring public safety.
We trust this summary has deepened your understanding. Thank you for your readership and valuable time.
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