1. Introduction to MedDRA® (Medical Dictionary for Regulatory Activities)
MedDRA® is a registered trademark of the International Federation
of Pharmaceutical Manufacturers and Associations (IFPMA)

2. What is MedDRA? Med = Medical D = Dictionary for R = Regulatory
A = Activities

3. Objectives for MedDRA Development
To provide:
An international multi-lingual terminology
Standardized communication between industry and regulators
Support of electronic submissions
Application through all phases of the development cycle

4. Objectives for MedDRA Development (cont)
To provide (cont):
Classification for a wide range of clinical information
Support for multiple medical product areas
A terminology that saves time, resources, and money

5. MedDRA Definition
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 pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.
e.g. in full regulatory process:
Clinical studies
- Reports of spontaneous adverse reactions and events
- Regulatory submissions
- Regulated product information

6. MedDRA Hierarchy System Organ Class (SOC) High Level Group Term (HLGT)
High Level Term (HLT)
Preferred Term (PT)
Lowest Level Term (LLT)

7. System Organ Classes Blood and lymphatic system disorders
Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
General disorders and administration site conditions
Hepatobiliary disorders
Immune system disorders
Infections and infestations
Injury, poisoning and procedural complications
Investigations
Metabolism and nutrition disorders
Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system disorders
Pregnancy, puerperium and perinatal conditions
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Social circumstances
Surgical and medical procedures
Vascular disorders

8. MedDRA Codes Each MedDRA term assigned an 8-digit numeric code
The code is non-expressive
Codes can fulfill a data field in various electronic submission types (e.g., E2b)
Initially assigned alphabetically by term starting with
New terms are assigned sequentially
Supplemental terms are assigned codes

9. MedDRA Codes (cont) Terms are being renamed
When terms are renamed, the code number is reused for the renamed term
Renaming has been done for spelling errors, hyphenation, and parenthesis changes
When HLT or HLGT terms are removed from the terminology, they are deleted – NOT moved to the LLT level and made non-current

10. Non-Current Terms
Non-current terms are flagged at the LLT level within MedDRA
Not recommended for continued use
Retained within the terminology to preserve historical data for retrieval and analysis
Terms very vague, ambiguous, out-dated, truncated, or misspelled
Terms derived from other terminologies that do not fit MedDRA rules

11. A Multi-Axial Terminology
Multi-axial = the representation of a medical concept in multiple SOCs
Allows terms to be grouped by different classifications
Allows retrieval and presentation via different data sets
Allows an automatic assignment of predefined term groupings

12. A Multi-Axial Terminology (cont)
SOC = Respiratory, thoracic and
mediastinal disorders
SOC = Infections and
infestations
HLGT = Respiratory tract
infections
HLGT = Viral infectious
disorders
HLT =Viral upper respiratory
tract infections
HLT = Influenza viral
infections
PT = Influenza

13. A Multi-Axial Terminology (cont)
SOC = Endocrine
disorders
SOC = Metabolism and nutrition disorders
HLGT = Glucose metabolism disorders (incl diabetes mellitus)
HLT = Diabetes mellitus (incl subtypes)
PT = Diabetes mellitus

14. MSSO Contacts Mail Telephone Fax VAR1/MSSO 12011 Sunset Hills Road
Reston, VA
USA
Telephone
Toll-free Worldwide (AT&T)
Fax

15. MSSO Contacts (cont) To Subscribe by Web page Products and Services
Website
click on subscribing to MedDRA
Web page
Products and Services
Toll-free Worldwide (AT&T)

16. MSSO Contacts (cont) Help Desk Phone E-mail
International AT&T Toll Free:
Direct Dial (USA):

17. Acknowledgements
COSTART Thesaurus Fifth Edition Copyright 1995 US Food and Drug Administration (FDA)
Hoechst Adverse Reaction Terminology System (HARTS)© 1992 Aventis Pharma
ICD-9-CM International Classification of Diseases, Ninth Revision, Clinical Modification, Copyright© 1998 Medicode, Inc.

18. Acknowledgements (cont)
Japanese Adverse Reaction Terminology (J-ART), is a product of the Japanese Ministry of Health, Labour and Welfare (MHLW)
MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
WHO Adverse Reaction Terminology (WHO-ART), Copyright World Health Organization Collaborating Centre for International Drug Monitoring