Introduction to MedDRA®

(Medical Dictionary
for Regulatory Activities)

MedDRA® is a registered trademark of the International Federation

of Pharmaceutical Manufacturers and Associations (IFPMA)
 What is MedDRA?

Med = Medical
D = Dictionary for
R = Regulatory
A = Activities

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 2

 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

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 3

 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

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 4

 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.

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 5

 MedDRA Hierarchy
System Organ Class (SOC)

High Level Group Term (HLGT)

High Level Term (HLT)

Preferred Term (PT)

Lowest Level Term (LLT)

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 6
 System Organ Classes
• Blood and lymphatic system disorders • Musculoskeletal and connective tissue
• Cardiac disorders disorders
• Congenital, familial and genetic disorders • Neoplasms benign, malignant and unspecified
• (incl cysts and polyps)
Ear and labyrinth disorders
• Nervous system disorders
• Endocrine disorders
• Pregnancy, puerperium and perinatal
• Eye disorders
conditions
• Gastrointestinal disorders
• Psychiatric disorders
• General disorders and administration site
• Renal and urinary disorders
conditions
• Reproductive system and breast disorders
• Hepatobiliary disorders
• Respiratory, thoracic and mediastinal disorders
• Immune system disorders
• • Skin and subcutaneous tissue disorders
Infections and infestations
• • Social circumstances
Injury, poisoning and procedural
complications • Surgical and medical procedures
• Investigations • Vascular disorders
• Metabolism and nutrition disorders
MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 7
 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 10000001
– New terms are assigned sequentially

• Supplemental terms are assigned codes

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 8
 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

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 9

 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
MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 10
 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

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 11

 A Multi-Axial Terminology (cont)
SOC = Respiratory, thoracic and SOC = Infections and
mediastinal disorders infestations

HLGT = Respiratory tract HLGT = Viral infectious

infections disorders

HLT =Viral upper respiratory HLT = Influenza viral

tract infections infections

PT = Influenza
MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 12
 A Multi-Axial Terminology (cont)
SOC = Endocrine SOC = Metabolism and
disorders nutrition disorders

HLGT = Glucose metabolism disorders (incl diabetes mellitus)

HLT = Diabetes mellitus (incl subtypes)

PT = Diabetes mellitus
MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 13
 MSSO Contacts
• Mail
MSSO
VAR1/MSSO
12011 Sunset Hills Road
Reston, VA 20190-3285
USA
• Telephone
– Toll-free Worldwide 877.258.8280 (AT&T)
• Fax
– 703.345.7791

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 14

 MSSO Contacts (cont)
• To Subscribe by
– E-mail
• mssosubscribe@ngc.com
– Website
• www.meddramsso.com click on subscribing to
MedDRA
• Web page
– www.meddramsso.com
• Products and Services
– Toll-free Worldwide 877.258.8280 (AT&T)

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 15

 MSSO Contacts (cont)
Help Desk
• Phone
• International AT&T Toll Free: 877.258.8280
• Direct Dial (USA): 703.345.7799

• E-mail
• mssohelp@ngc.com

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 16

 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.

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 17

 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

MSSO-DI-6197-8.1.0 ©2005 Northrop Grumman Corporation. All Rights Reserved. 18