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MedDRA Terminology -

a brief overview and update

Andrea Neal, DMD, MPH

Office of Post-Marketing Drug Risk Assessment 

Center for Drug Evaluation and Research

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MedDRA Terminology

• ICH Harmonized Medical Terminology for 

Regulatory Purposes

• An International Medical Terminology (IMT)

• Multi-axial terminology built upon 5-levelHierarchical Structure

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Current Situation Makes Exchange

of Information Difficult

• Research Institutions and Practitioners

 –  create multiple submissions in various terminologies

• Industry / CROs

 –  receive reports in various terminologies

• FDA report evaluators

 –  receive submissions coded in various terminologies

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Benefits of the Standard Terminology

• Improve regulatory communications between all

involved parties

• Facilitate consistent coding and decrease

information loss, thereby enhancing qualityreview

• Decrease time spent by reviewers on data

normalization

(cont…)

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Benefits of the Standard Terminology

• Decrease submission time for INDs/NDAs

• Improve product labeling

• Facilitate shift to electronic submissions - pre & post

• Improve epidemiological study on global scale

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ICH guiding principles• Build from existing terminologies to maximize

compatibility

• Focus on international community needs

• Ensure worldwide use through collaboration and participation in development

• Ensure mechanisms and structures to enable

translation into many languages

• Ensure long-term maintenance

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Terminologies Included

• MCA Medical Terminology

• COSTART (5th ed.)

•WHO-ART (96:4)

• J-ART (1996)

• ICD-9

• ICD-9-CM (4th revision)• HARTS (release 2.2)

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MedDRA Terminology

• Progression from version 1.0 to version 2.0

•Same 5-level hierarchical structure

• Thousands of additional terms

• Complete re-write of several SOCs

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 H L G T

I n n e r e a r a n d V I I I t h c r a n i a l n e r v e d i s o r d e r s

H L G T

E x t e r n a l e a r d i s o r d e r s ( e x c c o n g e n i t a l )

H L G T

M i d d l e e a r d i s o r d e r s ( e x c c o n g e n i t a l )

H L G T

C o n g e n i t a l E a r D i s o r d e r s ( e x c d e a f n e s s )

H L T

M i s c e l l a n e o u s e a r s y m p t o m s a n d s i g n s

P T

E a r i n f e c t i o n N O S

P T

E a r t u b e r c u l o s i s

P T

A u r a l p o l y p

D i s o r d e r e a r  

O t h e r d i s o r d e r s o f e a r  

D e g e n e r a t i v e a n d v a s c u l a r d i s o r d e r s o f e a r  

D e g e n e r a t i v e a n d v a s c u l a r d i s o r d e r s , u n s p e c i f i e d

U n s p e c i f i e d d i s o r d e r o f e a r  

O t h e r d i s o r d e r s o f e a r , o t h e r  

O t h e r s p e c i f i e d d i s o r d e r s o f e a r  O t h e r s p e c i f i e d d i s o r d e r o f e a r  

E a r d i s o r d e r  

P T

E a r d i s o r d e r N O S

P T

F o r e i g n b o d y r e t a i n e d i n e a r  

H L T

M i s c e l l a n e o u s e a r d i a g n o s e s

H L G T

M i s c e l l a n e o u s e a r d i s o r d e r s

H L G T

H e a r i n g d i s o r d e r s

S O C

E a r & l a b y r i n t h d i s o r d e r s

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Scope of MedDRA

• Diseases

• Diagnoses

• Signs

• Symptoms

(cont…..)

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Scope of MedDRA (cont.)

• Therapeutic indications

• Investigation names & qualitative

results

• Medical & surgical procedures

• Medical, social, family history

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Scope of possible, future expansion:

• drug /product terminology

• equipment / device / diagnostic prod.

•study design

•  patient demographic terms

• device failure

•  population qualifiers (i.e. rare, frequent)• descriptors of severity

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Use throughout regulatory cycle

• Clinical Studies

• Adverse Event/Reaction Reporting

• Regulatory Submissions

• Regulated Product Information

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Adverse Event Reporting in CDER -

changing environment• Rapidly growing # reports - 200,000 + / yr.

• Faster review cycle

• More complex pharmaceuticals

• Aging population using more pharmaceuticals

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MedDRA Implementation: FDA

• MedDRA implemented Nov. ‘97

•Launch of AERS (Adverse Event ReportingSystem) - January ‘98

• All Adverse Event Reports entered to databasecoded in MedDRA

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ANPRM Issued 11/5/98

• For Electronic ADR Reporting

• To Implement:

 – ICH M1 (MedDRA)

 – ICH M2 (Electronic Transmission Standards)

 – ICH E2B (Safety Report Data Elements)

• Goal of Paperless Environment by 2002

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ANPRM (cont.)

• Comments specifically solicited regarding:

 – whether exemptions should be granted

• if so, their basis

 – cost benefits / cost burdens

 – timeframes for implementing requirement

• Comments received and being considered

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 Next Steps

• Continue implementation on post-market side

• Prepare NPRM for Electronic ADR Reporting

• Lend CDER/CBER experience to theimplementation of MedDRA on pre-market

 processes

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Web Sites to Check Out

• http://www.fda.gov

• http://www.fda.gov/cder 

• http://www.fda.gov/cder/aers/index.htm

• http://www.fda.gov/medwatch

• http://www.meddramsso.com