Medical Dictionary for Regulatory Activities (MedDRA)
A Medical Dictionary for Regulatory Activities (MedDRA) is a Medical Coding Dictionary and a Clinical Terminology Standard that is used for sharing regulatory information and clinical safety data about human medical products.
- AKA: MedDRA Dictionary, MedDRA Terminology.
- Context:
- Website: https://www.meddra.org
- It has been developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
- It is maintained and distributed by the Maintenance and Support Services Organization (MSSO).
- It is available as MedDRA Desktop Browser (MDB) and a MedDRA Web-Based Browser (WBB).
- It is a 5-Level Hierarchical Clinical Terminology.
- Example(s):
- Counter-Example(s):
- Coding Symbols for Thesaurus of Adverse Reaction Terms (COSTART).
- International Classification of Diseases 9 Revision Clinical Modification (ICD9CM),
- SNOMED CT Controlled Vocabulary,
- World Health Organisation Adverse Reactions Terminology (WHO-ART),
- World Health Organisation Drug Dictionary (WHO-DD).
- See: Medical Product, Clinical Terminology Standard, Medical Database, Medical Ontology, Clinical Research Glossary, Clinical Data Standard, Medical Classification System, Adverse Reaction, Adverse Effect, Medical Treatment, Medical Diagnosis, Drug Development Clinical Trial.
References
2022a
- (MedDRA, 2022) ⇒ https://www.meddra.org/how-to-use/support-documentation/english/welcomeT Retrieved:2022-03-13.
- QUOTE: In the late 1990s, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed MedDRA, a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. ICH's powerful tool, MedDRA is available to all for use in the registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. Products covered by the scope of MedDRA include pharmaceuticals, biologics, vaccines and drug-device combination products. Today, its growing use worldwide by regulatory authorities, pharmaceutical companies, clinical research organisations and health care professionals allows better global protection of patient health.
2022b
- (NIH-NLM, 2022) ⇒ https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/MDR/index.html Retrieved:2022-03-13.
- QUOTE: The Medical Dictionary for Regulatory Activities (MedDRA) was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee. The Maintenance and Support Services Organization (MSSO) serves as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the biopharmaceutical industry and regulators.
Purpose
MedDRA was designed for the specific use of sharing regulatory information and clinical safety data for human medical products worldwide.
Description
MedDRA is an international medical terminology with an emphasis on use for data entry, retrieval, analysis, and display. It applies to all phases of drug development, excluding animal toxicology, and to the health effects and malfunction of devices. An appendix includes concept descriptions which describe how a medical concept is interpreted, used, and classified within the MedDRA terminology. It is not intended as a medical definition. The concept descriptions are intended to aid the consistent and accurate use of MedDRA in coding, retrieval, and analysis.
- QUOTE: The Medical Dictionary for Regulatory Activities (MedDRA) was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee. The Maintenance and Support Services Organization (MSSO) serves as the repository, maintainer, and distributor of MedDRA as well as the source for the most up-to-date information regarding MedDRA and its application within the biopharmaceutical industry and regulators.
2022c
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/MedDRA Retrieved:2022-3-13.
- A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation. [1] Also, it is the adverse event classification dictionary. [2] The first version of MedDRA was released in 1999 in English and Japanese. MedDRA is now also translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish. In many countries/regions the use of MedDRA by biopharmaceutical companies is mandated for safety reporting. Many other industries, including tobacco and cosmetics, are also beginning to use MedDRA for capturing adverse health events.
All Regulatory Members of ICH are expected to implement MedDRA within 5 years.
As of 2020, the following ICH Regulatory Members have implemented MedDRA: EC, Europe; FDA, United States; HSA, Singapore; Health Canada, Canada; MHLW/PMDA, Japan; Swissmedic, Switzerland; and TFDA, Chinese Taipei. Information about the implementation status of MedDRA by ICH Regulatory Members is updated by ICH on its website. [3]
MedDRA is widely used internationally, with more than 6,800 subscribing organizations from over 125 countries.
Each organization, regardless of its number of users, requires only one subscription to MedDRA.
- A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation. [1] Also, it is the adverse event classification dictionary. [2] The first version of MedDRA was released in 1999 in English and Japanese. MedDRA is now also translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish. In many countries/regions the use of MedDRA by biopharmaceutical companies is mandated for safety reporting. Many other industries, including tobacco and cosmetics, are also beginning to use MedDRA for capturing adverse health events.
- ↑ Lenita Lindström-Gommers and Theresa Mullin "International Conference on Harmonization: Recent Reforms as a Driver of Global Regulatory Harmonization and Innovation in Medical Products"
- ↑ Health Canada, Canada "About the Medical Dictionary for Regulatory Activities"
- ↑ M1 MedDRA Terminology Content is copied from this source, which is © ICH. It may be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright is acknowledged.
2020
- (Dutta et al., 2020) ⇒ Anamika Dutta (2020). "MedDRA - Terminologies & Coding", In: 6th Asia Pacific Pharmacovigilance Training Course.
- QUOTE: MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from premarketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.
2011
- (WHO, 2011) ⇒ "Introductory Guide MedDRA Version 14.0". MSSO-DI-6003-14.0.0
- QUOTE: The Medical Dictionary for Regulatory Activities (MedDRA) Terminology is the international medical terminology developed under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. This guide describes the development, scope, and structure of the terminology (...)
The MedDRA Working Party enhanced the United Kingdom MCA’s (Medicines Control Agency) medical terminology to produce MedDRA Version 1.0.
MedDRA Version 2.0 was signed off as the implementable version of the terminology at the ICH-4 conference in July 1997. A change in name and modified acronym were agreed upon at this meeting. Hence, MedDRA is used for versions up to Version 1.5, while the implementable version (Version 2.0) and future versions are known as the MedDRA terminology.
- QUOTE: The Medical Dictionary for Regulatory Activities (MedDRA) Terminology is the international medical terminology developed under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. This guide describes the development, scope, and structure of the terminology (...)
2010
- (Babre. 2010) ⇒ Deven Babre (2010). "Medical Coding in Clinical Trials". In: Perspectives in clinical research, 1(1), 29.
- QUOTE: There are several standardized medical coding dictionaries in the market; however five dictionaries listed below are used for coding:
- Medical Dictionary for Regulatory Activities (MedDRA) is a medical coding dictionary developed by Maintenance and Support Services Organisation (MSSO). MedDRA is supported by International Conference on Harmonisation (ICH) on Technical Requirements for Registration of Pharmaceuticals for Human use. Prior to development of MedDRA, there was no internationally accepted medical terminology for biopharmaceutical regulatory purposes.
MedDRA is used for coding
- medical terms generated during all phases of clinical trial, excluding animal toxicology,
- therapeutic indications which include signs, symptoms, diseases, diagnosis, or prophylaxis of disease, and modification of functions,
- coding names and quantitative results of investigations, surgical procedures and medical/social/family history.
- (...)
- MedDRA has five hierarchical levels as listed below (...)
- Medical Dictionary for Regulatory Activities (MedDRA) is a medical coding dictionary developed by Maintenance and Support Services Organisation (MSSO). MedDRA is supported by International Conference on Harmonisation (ICH) on Technical Requirements for Registration of Pharmaceuticals for Human use. Prior to development of MedDRA, there was no internationally accepted medical terminology for biopharmaceutical regulatory purposes.
1999
- (Brown et al., 1999) ⇒ Elliot G. Brown, Louise Wood, and Sue Wood (1999). "The Medical Dictionary for Regulatory Activities (MedDRA)". In: Drug safety, 20(2), 109-117.
- QUOTE: MedDRA is a hierarchical terminology with 5 levels and is multiaxial: terms may exist in more than 1 vertical axis, providing specificity of terms for data entry and flexibility in data retrieval. Terms in MedDRA were derived from several sources including the WHO’s adverse reaction terminology (WHO-ART), Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART), International Classification of Diseases (ICD) 9 and ICD9-CM. It will be maintained, further developed and distributed by a Maintenance Support Services Organisation (MSSO).