cWhat’s New
MedDRA Version 20.1

September 2017
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Acknowledgements

ACKNOWLEDGEMENTS
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Table of Contents

Table of Contents
1.

DOCUMENT OVERVIEW ....................................................................................... 1

2.

VERSION 20.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 TRANSLATION CHANGES .............................................................................. 3
2.2.1

3.

Translation Review ............................................................................. 3

NEW DEVELOPMENTS IN VERSION 20.1 ........................................................... 4
3.1 REVISIONS TO “DRUG USE DISORDER” TERMS ......................................... 4
3.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 5
3.3 PROACTIVITY REQUESTS ............................................................................. 5
3.3.1

Review of foreign body terms ............................................................. 5

3.4 SELF-SERVICE APPLICATION ....................................................................... 64.

SUMMARY OF CHANGES ..................................................................................... 8
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ......................................... 8
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ......................... 10
4.3 MedDRA TERM COUNTS .............................................................................. 11
4.4 MODIFIED PT AND LLT NAMES ................................................................... 14
4.5 LLT CURRENCY STATUS CHANGES ........................................................... 15

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
Figure 3-1 Revisions to “Drug use disorder” terms ............................................... 4
Figure 3-2 PT Foreign body.................................................................................. 6
Figure 3-3 Self-Service Application Home Page .................................................. 7
LIST OF TABLES
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs ...................................... 8
Table 4-2 Summary of Impact on PTs ................................................................. 9
Table 4-3 Summary of Impact on LLTs ............................................................... 9
Table 4-4 Summary of Impact on SMQs ........................................................... 10
Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 11
Table 4-6 MedDRA Term Counts ...................................................................... 14
Table 4-7 Modified PT/LLT Names .................................................................... 14
Table 4-8 LLT Currency Changes ..................................................................... 17

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Document Overview

1. DOCUMENT OVERVIEWThis What’s New document contains information on the origins and types of changes
made to the Medical Dictionary for Regulatory Activities (MedDRA) between Versions
20.0 and 20.1.
Section 2, Version 20.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 20.1, highlights changes in Version 20.1
related to change request submissions, new initiatives, information on Standardised
MedDRA Queries (SMQs), and any recent updates to software tools provided by the
MSSO.
Section 4, Summary of Changes, contains details on:Term historyThe impact of this version on the terminology (in tables)Impact on the records in MedDRA files



MedDRA term and SMQ counts



Modified Lowest Level Terms (LLT) and Preferred Term (PT) names

All LLTs in MedDRA that had a currency status change.

All updated documentation associated with this version is located in the distribution filein Adobe® Portable Document Format (PDF) or, for some documents, Microsoft Excel.
Please refer to the !!Readme.txt file for a complete listing.
The Maintenance and Support Services Organization (MSSO) Help Desk can bereached at International AT&T Toll Free at 1-877-258-8280 or mssohelp@meddra.org.

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Version 20.1 Change Requests

2. VERSION 20.1 CHANGE REQUESTS
2.1

TERMINOLOGY CHANGES

Changes to MedDRA result from user change requests, from proactivity requests
submitted by MedDRA users, and from internal change requests. Internal change
requests result from MSSO maintenance activities and from special working group
activities in which the MSSO participates.
MedDRA Version 20.1 is a simple change version which means that changes are madeonly at the PT and LLT levels of the MedDRA hierarchy.
Change requests involve both MedDRA updates and SMQ changes. There were a totalof 1,764 change requests processed for this version; 1,476 change requests wereapproved and implemented, and 272 change requests were not approved. There are, in
addition, 16 change requests suspended for further consideration and resolution beyond
this version.
Information on specific changes (e.g., new terms added, LLT promotions, PT
demotions, PT primary SOC changes, etc.) which occurred since the prior MedDRA
release can be obtained via the Version Report included with each respective MedDRA
download. In addition, users may wish to use the MedDRA Version Analysis Tool
(MVAT) which is an online tool that compares any two MedDRA versions– including
non-consecutive versions – to identify changes. The output of MVAT is similar to the
Version Report. MVAT is provided free of charge to MedDRA users as part of theirsubscription.
Between MedDRA releases, the MSSO makes available weekly supplemental update
files, which are approved changes that will be implemented for the next MedDRA
version. The supplemental files may be helpful for users to identify changes that will be
implemented in the next release.
An explanation of all changes considered (approved and not approved) for MedDRA
Version 20.1 is accessible as a cumulative Detail Report included in the MedDRA
English version download. Users may review all change requests considered by the
MSSO from MedDRA Version 5.1 to the present in WebCR.
Figure 2-1 (shown below) summarizes all changes made per System Organ Class(SOC) and may be useful to gauge the impact of changes to a specific area of
MedDRA. The data are derived from the difference in counts of primary and secondary
PT/LLTs, HLTs, and HLGTs for Version 20.1 (shown in Table 4-6) and thecorresponding information for Version 20.0. Additionally, term name changes and LLTcurrency status changes are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA Version 20.1.

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Version 20.1 Change Requests

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…
Hepatobiliary disorders
Immune system disorders
Infections and infestations
Injury, poisoning and procedural complications
Investigations
Metabolism and nutrition disorders
Musculoskeletal and connective tissue…
Neoplasms benign, malignant and…
Nervous system disorders
Pregnancy, puerperium and perinatal…
Product issues
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

81
34
78
8
35
46
92
61
21
40
40
195
160
43
139
87
84
38
42
42
38
42
67
82
9
104
104

Figure 2-1 Net Changes of Terms per SOC

2.2

TRANSLATION CHANGES

2.2.1 Translation Review
As part of our regular quality process, the MSSO is conducting a review of terms
translated from English into the supported MedDRA languages, except Japanese. This
will be an ongoing effort that is expected to last until MedDRA Version 21.0 (March2018) and will result in updates to term names in the respective translations of
MedDRA. The list of terms updated will be available in the associated version reports
included in the MedDRA download for each language. Please see the Change Request
section of the MedDRA website if you wish to request an improvement in the translationof a term or terms in any non-English or non-Japanese translation of MedDRA.

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New Developments in Version 20.1

3. NEW DEVELOPMENTS IN VERSION 20.1
3.1

REVISIONS TO “DRUG USE DISORDER” TERMSIn MedDRA Version 20.0, several drug/substance abuse and dependence PTs were
demoted under new drug/substance use disorder PTs in accordance with the updated
DSM-5 criteria which combine the categories of “abuse” and “dependence” in a single
disorder. The MSSO has reconsidered these demotions based on feedback from users
who note that from a pharmacovigilance perspective, abuse and dependence are
distinct and important concepts that warrant separate representation at the PT level.
Therefore LLT Drug abuse and LLT Drug dependence were promoted to PT level fromunder PT Drug use disorder. Similarly, LLT Drug dependence, antepartum and LLT
Drug dependence, postpartum were promoted to PT level from under PT Drug use
disorder, antepartum and PT Drug use disorder, postpartum, respectively. In addition,
LLT Substance abuse and LLT Substance dependence were promoted to PT level fromunder PT Substance use disorder. The LLTs that were previously subordinate to thesePTs in MedDRA Version 19.1 were moved under the newly promoted PTs. The figure
below shows the concepts of abuse, dependence, and use disorder as separate PTs
under HLT Substance related and addictive disorders in MedDRA Version 20.1.

Figure 3-1 Revisions to “Drug use disorder” terms

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New Developments in Version 20.1

3.2

STANDARDISED MedDRA QUERIES (SMQs)

New SMQ Infective pneumonia was added in MedDRA Version 20.1. There are now
102 level 1 SMQs in production as of this version. Additionally, there were 297
approved changes to existing SMQs. To view changes to existing SMQs, please review
the MedDRA Version 20.1 Version Report.
Please see the MedDRA Version 20.1 SMQ Introductory Guide for detailed informationon the new SMQ Infective pneumonia.

3.3

PROACTIVITY REQUESTS

The proactive maintenance process allows MedDRA users to propose general changes
to MedDRA outside of the established change request process. These proactivity
requests may address inconsistencies, make corrections, or suggest improvements.
During the Version 20.1 change request processing period, the MSSO evaluated threeproactivity proposals submitted by MedDRA users. Of the three proposals, one was
implemented and two were not approved. See below for details on the implemented
request. The MSSO publishes and updates a list of all proposals received and theirstatus on the Change Request section of the MedDRA website.
The MSSO is interested in learning about any ideas that users may have about“proactive” improvements to MedDRA. Please email your ideas for “proactive” MedDRA
improvements to the MSSO Help Desk. Be as specific as possible in describing yoursuggestion(s), and include a justification which explains why you think your proposal
should be implemented.
3.3.1 Review of foreign body terms
A MedDRA user requested that the MSSO consider reviewing the placement of “foreignbody” LLTs under PT Foreign body because there were a number of site-specific LLTs
mapped to HLT Non-site specific injuries NEC such as LLT Foreign body in nose thatwere not optimally placed.
After performing a review, several modifications were made to accommodate thisrequest. A total of 6 new PTs have been added for MedDRA Version 20.1 and one LLT
has been promoted to the PT level with HLT links to the appropriate site of specificity.
The PTs are as follows:PT Foreign body in gastrointestinal tract
PT Foreign body in reproductive tract
PT Foreign body in respiratory tract
PT Foreign body in urogenital tract

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5

New Developments in Version 20.1


PT Foreign body in ear*
PT Musculoskeletal foreign body
PT Soft tissue foreign body

*Promoted LLT

LLTs have been moved from PT Foreign body to more specific PTs accordingly. See
the figure below for how PT Foreign body and underlying LLTs will appear in MedDRA
Version 20.1.

Figure 3-2 PT Foreign body

3.4

SELF-SERVICE APPLICATIONThe MSSO has developed a new web-based tool called the “Self-Service Application” toprovide support for frequently asked Help Desk questions. The Self-Service Application
can be accessed at the following URL: https://apps.meddra.org/selfservice/. See thefigure below which shows the Self-Service Application home page.
The functions for the new tool focus on providing support for frequently asked Help
Desk questions and include the following functions:Primary Point of Contacts can retrieve their organization’s MedDRA password
and unzip passwords for MedDRA release files
Retrieve your organization’s MedDRA ID and the email address for yourorganization’s Primary Point of Contact
Check the MedDRA subscription status of business partners
Print or save to PDF training certificates for face-to-face classes attended

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6

New Developments in Version 20.1

Figure 3-3 Self-Service Application Home Page

Instead of providing password and account information via email, the MSSO plans torefer users to the Self-Service Application to obtain this information. A short videocast
has been developed to explain how to use this tool which can be found in the Training
Materials section of the MedDRA website under “Tools” https://www.meddra.org/training-materials.

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Summary of Changes

4. SUMMARY OF CHANGES
4.1

SUMMARY OF IMPACT ON THE TERMINOLOGY

The tables below (Tables 4-1 through 4-5) summarize the impact on MedDRA in
Version 20.1. These tables are intended only as a reference. For detailed information on
the changes to Version 20.1, please see the MedDRA Version Report included within
the MedDRA download.
SOC, HLGT, HLT Changes
Level

Change Request Action Net Change v20.0 V20.1

SOC

Total SOCs

0

27

27

New HLGTs000

Merged HLGTs

0

0

0

Total HLGTs1

0

337

337

New HLTs000

Merged HLTs

0

0

0

Total HLTs1

0

1,738

1,738

HLGT

HLT

Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs

MedDRA v20.1 is a simple change version which means changes are only made at the
PT and LLT levels of the MedDRA hierarchy; hence there are no changes in the number
of HLTs and HLGTs.
1 Total net change of HLGTs or HLTs equals the number of new HLGTs or HLTs minus

the number of respective merged HLGTs or HLTs.

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Summary of Changes

PT Changes
Level Change Request Action

PT

v20.0

V20.1

New PTs

324

288

Promoted LLTs

24

24

Demoted PTs

59

37

Net Change1

289

275

Total PTs

22,49922,774

Table 4-2 Summary of Impact on PTs
1Net change of PTs equals the number of new PTs plus the number of promoted LLTs

minus the number of demoted PTs.
LLT Changes
Level Change Request Action Net Change

v20.0

V20.1

LLT

Current Terms

762

67,99568,757

LLT

Non-current Terms

16

9,253

9,269

LLT

Total LLTs1

778

77,24878,026

Table 4-3 Summary of Impact on LLTs

1Total LLTs include PTs as they are also in the LLT distribution file.

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Summary of Changes

New SMQs
Level Net Change

v20.0

V20.1

1

1

101

102

2

0

82

82

3

0

20

20

4

0

16

16

5

0

2

2

Table 4-4 Summary of Impact on SMQs

4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES
The table below summarizes the impact on MedDRA in Version 20.1. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

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0Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified010Summary of Changes

HLT_PT.ASC

MDHIER.ASC

PT.ASC

LLT.ASC

Added

504

Removed63

Modified

0

Added

552

Removed83

Modified

0

Added

312

Removed37

Modified

9

Added

778

Removed0Modified4341

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added

1

Removed0Modified

221

Added

1,823

Removed0Modified

158

Table 4-5 Summary of Impact on Records in MedDRA Files

1 The number of SMQs added includes both top level (Level 1) and sub-search SMQs.

4.3

MedDRA TERM COUNTS

The table below shows term counts by SOC for HLGTs, HLTs, primary and secondary
PTs and LLTs, and primary PTs and LLTs.

SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Blood andlymphatic systemdisorders

1,152

293

4,255

1,011

88

17

Cardiac disorders

1,445

339

2,369

610

36

10

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HLTs3 HLGTs3

11

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Congenital,familial andgenetic disorders

3,512

1,338

3,512

1,338

98

19

Ear and labyrinth
disorders

431

88

813

206

17

6

Endocrine
disorders

677

191

1,779

533

38

9

Eye disorders

2,452

600

3,735

1,011

64

13

Gastrointestinal
disorders

3,841

859

7,558

1,717

108

21

General disordersandadministration site
conditions

2,443

989

3,259

1,284

36

7

Hepatobiliary
disorders

655

195

1,470

429

19

4

Immune systemdisorders

465

142

2,601

697

26

4

Infections andinfestations

7,113

1,916

7,461

2,008

149

12

Injury, poisoning
and procedural
complications

6,598

1,158

9,170

2,305

78

9

Investigations

13,611

5,578

13,611

5,578

106

23

Metabolism andnutrition disorders

956

282

2,651

757

63

14

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HLTs3 HLGTs3

12

Summary of Changes
SOC

LLTs*
(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2

Musculoskeletaland connective
tissue disorders

2,539

450

6,498

1,264

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,545

1,955

9,262

2,257

202

39

Nervous systemdisorders

3,553

945

7,146

1,917

107

20

Pregnancy,
puerperium andperinatalconditions

1,635

223

2,873

584

48

8

Product issues

626

152

633

156

21

2

Psychiatricdisorders

2,348

518

3,191

757

76

23

Renal and urinary
disorders

1,220

352

2,600

734

32

8

Reproductive
system andbreast disorders

1,725

477

4,177

1,160

52

16

Respiratory,
thoracic andmediastinal
disorders

1,717

528

4,200

1,133

49

12

Skin andsubcutaneous
tissue disorders

2,080

493

4,738

1,356

56

10

Socialcircumstances

641

274

641

274

20

7

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HLTs3 HLGTs3

13

Summary of Changes
LLTs*(Primary)1

PTs(Primary)1

LLTs*(Primary andSecondary)2

PTs(Primary andSecondary)2Surgical andmedicalprocedures

4,713

2,130

4,713

2,130

141

19

Vasculardisorders

1,333

309

6,694

1,624

68

11

Total

78,026

22,774SOC

HLTs3 HLGTs3

Table 4-6 MedDRA Term Counts
1Primary count only includes the number of terms that are primarily linked to thedesignated SOC at either the LLT level or the PT level. The sums of primary LLTs andPTs match those in Tables 4-2 and 4-3.
2Total count includes the number of terms that are both primarily and secondarily linked

to the designated SOC at either the LLT level or the PT level. Therefore, the sums of
total LLTs and PTs are greater than those in Tables 4-2 and 4-3.
3The HLT and HLGT counts are not necessarily unique values given MedDRA’s multi-

axiality (see Section 2.2 of the Introductory Guide for a discussion of multi-axiality).
There are some HLTs that are counted in more than one SOC. For example, HLT
Connective tissue disorders congenital and HLGT Musculoskeletal and connective
tissue disorders congenital are counted in both SOC Congenital, familial and genetic
disorders and SOC Musculoskeletal and connective tissue disorders. The sums of HLTs
and HLGTs are greater than those found in Table 4-1.
4.4

MODIFIED PT AND LLT NAMESAs part of ongoing MedDRA maintenance activities, existing PTs and LLTs can be
modified (renamed) to correct for misspelling, double spacing, capitalization, or othererrors that meet the renaming criteria in MedDRA. This rename provision retains theoriginal MedDRA code of the term and preserves its original meaning.
The table below lists two terms modified in English MedDRA Version 20.1.
Code

Level

Term Name in v20.0

Term Name in v20.1

10059971

LLT

Bordet-Wasserman reaction

Bordet-Wassermann reaction

10052456

LLT

Parovarian cyst

Paraovarian cyst

Table 4-7 Modified PT/LLT Names
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Summary of Changes

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects the 16 terms at the LLT level in MedDRA Version 20.1 thathave a change in their currency status along with the rationale for the change.

Lowest Level Term

Currency
StatusChanged toCommunication issue

Non-current

Delayed adverse
reactions to gadolinium

Non-current

Dementia due toCreutzfeld-Jakob diseaseNon-current

Dementia due toCreutzfeldt-Jacob
diseaseNon-current

Dementia due to headtraumaNon-current

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Rationale
LLT Communication issue was changed to a status of
non-current to avoid potential confusion with PT Productcommunication issue and other general communication
disorder concepts. Note LLT Communication issue wasa PT that was demoted to an LLT under PT Productcommunication issue for MedDRA Version 20.1.
LLT Delayed adverse reactions to gadolinium waschanged to a non-current status because the term is
ambiguous. It could refer to a hypersensitivity type IVreaction or to the retention of gadolinium and its longterm effects.
Dementia due to Creutzfeld-Jakob disease represents a"due to" concept which was inherited from otherterminologies. The term does not conform with thegeneral convention for the inclusion of combination terms
in MedDRA and was changed to a status of non-current.
A combination term is a single medical concept combinedwith additional medical wording that provides important
information on pathophysiology or etiology, and is aninternationally recognized, distinct and robust medical
concept.
Dementia due to Creutzfeldt-Jacob disease represents a"due to" concept which was inherited from otherterminologies The term does not conform with thegeneral convention for the inclusion of combination terms
in MedDRA and was changed to a status of non-current.
A combination term is a single medical concept combinedwith additional medical wording that provides important
information on pathophysiology or etiology, and is aninternationally recognized, distinct and robust medical
concept.
Dementia due to head trauma represents a "due to"concept which was inherited from other terminologies.
The term does not conform with the general convention
for the inclusion of combination terms in MedDRA andwas changed to a status of non-current. A combination
term is a single medical concept combined with additional
medical wording that provides important information on
pathophysiology or etiology, and is an internationallyrecognized, distinct and robust medical concept.

15

Summary of Changes

Lowest Level Term

Currency
StatusChanged to

Dementia due to
Huntington's diseaseNon-current

Enteritis due to calcivirus

Non-current

Fracture of upper end or
unspecified of tibia andfibula, open
Fracture of upper end or
unspecified part of tibia
and fibula, closed
Gastroenteritis calciviralNon-current

Non-current
Non-current

Hair colour graying

Non-current

Lymphocyte abnormal

Non-current

Misleading productinformation

Non-current

Non-NSF delayedadverse events togadolinium

Non-current

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Rationale
Dementia due to Huntington's disease represents a "dueto" concept which was inherited from other terminologies.
The term does not conform with the general convention
for the inclusion of combination terms in MedDRA andwas changed to a status of non-current. A combination
term is a single medical concept combined with additional
medical wording that provides important information on
pathophysiology or etiology, and is an internationallyrecognized, distinct and robust medical concept.
LLT Enteritis due to calcivirus was misspelled. The
correctly spelled LLT Enteritis due to calicivirus is anexisting term.
LLT Fracture of upper end or unspecified of tibia andfibula, open represents a combination of two separate
existing PTs – PT Tibia fracture and PT Fibula fracture.
LLT Fracture of upper end or unspecified part of tibia andfibula, closed represents a combination of two separate
existing PTs – PT Tibia fracture and PT Fibula fracture.
LLT Gastroenteritis calciviral is misspelled. The correctly
spelled LLT Gastroenteritis caliciviral is an existing term.
LLT Hair colour graying was changed to a status of noncurrent because it is a mixture of British English andAmerican English. Note that both LLT Hair color graying
and LLT Hair colour greying are available as of MedDRA
Version 20.1.
Lymphocyte abnormal can refer to either count,percentage or morphology and therefore is ambiguous inmeaning.
The word “information” is too broad in meaning as an LLT
under PT Product advertising issue for which LLT
Misleading product information was added. The term
was changed to a status of non-current because“misleading product information” may also refer to
instructions, labeling information or other specifications
about the product, in addition to advertising information.
LLT Non-NSF delayed adverse events to gadolinium waschanged to a status of non-current because the preferredwording is "reaction" rather than "event" in the context of
this sub-concept LLT. The correct wording of this concept“Non-NSF delayed adverse reaction to gadolinium” wasadded as sub-concept LLT to PT Gadolinium depositiondisease.

16

Summary of Changes

Lowest Level Term

Currency
StatusChanged to

Procidentia

Non-current

Umbilical cyst

Non-current

Rationale
Procidentia is an ambiguous term that is often used todescribe uterine prolapse, but also can refer to the moregeneral concept of prolapse.
Umbilical cyst is an ambiguous term and could be used
to refer to urachal cysts or to umbilical cord cysts. There
are specific LLTs / PTs for these concepts, for example
LLT Urachal cyst and LLT Umbilical cord cyst.

Table 4-8 LLT Currency Changes

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