C

What’s New
MedDRA Version 21.1

September 2018
000224

Acknowledgements

ACKNOWLEDGEMENTS
MedDRA® trademark is registered by IFPMA on behalf of ICH.

Disclaimer and Copyright NoticeThis document is protected by copyright and may, with the exception of the MedDRA
and ICH logos, be used, reproduced, incorporated into other works, adapted, modified,translated or distributed under a public license provided that ICH's copyright in the
document is acknowledged at all times. In case of any adaption, modification ortranslation of the document, reasonable steps must be taken to clearly label, demarcate
or otherwise identify that changes were made to or based on the original document. Any
impression that the adaption, modification or translation of the original document isendorsed or sponsored by the ICH must be avoided.
The document is provided "as is" without warranty of any kind. In no event shall the ICH
or the authors of the original document be liable for any claim, damages or other liability
arising from the use of the document.
The above-mentioned permissions do not apply to content supplied by third parties.
Therefore, for documents where the copyright vests in a third party, permission forreproduction must be obtained from this copyright holder.

What’s New MedDRA Version 21.1
September 2018
000224ii

Table of Contents

Table of Contents
1.

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

2.

VERSION 21.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 TRANSLATION CHANGES .............................................................................. 3
2.2.1
Translation Review.............................................................................. 33.

NEW DEVELOPMENTS IN VERSION 21.1 ........................................................... 4
3.1 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 4
3.2 PROACTIVITY REQUESTS ............................................................................. 4
3.2.1
Differentiation Between Administration Errors / Issues and Medication
Errors / Product Use Issues ................................................................ 4
3.2.2
Prophylaxis Terms .............................................................................. 5
3.2.3
LLTs Under PT Procedural complication ............................................. 64.

SUMMARY OF CHANGES ..................................................................................... 7
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ......................................... 7
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ........................... 9
4.3 MedDRA TERM COUNTS .............................................................................. 10
4.4 MODIFIED PT AND LLT NAMES ................................................................... 13
4.5 LLT CURRENCY STATUS CHANGES ........................................................... 14

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
LIST OF TABLES
Table 3-1 Updates to “Administration” and “Use” Terms ..................................... 5
Table 3-2 New Prophylaxis Terms and Existing Term Change Examples........... 6
Table 3-3 Examples of LLTs Moved from PT Procedural complication ............... 6
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs ...................................... 7
Table 4-2 Summary of Impact on PTs ................................................................. 8
Table 4-3 Summary of Impact on LLTs ............................................................... 8
Table 4-4 Summary of Impact on SMQs ............................................................. 9
Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 10
Table 4-6 MedDRA Term Counts ...................................................................... 13
Table 4-7 Modified PT/LLT Names .................................................................... 14
Table 4-8 LLT Currency Changes ..................................................................... 14

What’s New MedDRA Version 21.1
September 2018
000224iii

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
21.0 and 21.1.
Section 2, Version 21.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 21.1, highlights changes in Version 21.1
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:•

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•

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.

What’s New MedDRA Version 21.1
September 2018
0002241

Version 21.1 Change Requests

2. VERSION 21.1 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 21.1 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 was a totalof 1,516 change requests processed for this version; 1,283 change requests wereapproved and implemented, and 229 change requests were not approved. There are, in
addition, 4 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 21.1 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 21.1 (shown in Table 4-6) and thecorresponding information for Version 21.0. 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 21.1.

What’s New MedDRA Version 21.1
September 2018
0002242

Version 21.1 Change Requests

36

Blood and lymphatic system disorders

12

Cardiac disorders
Congenital, familial and genetic disorders

115

16

Ear and labyrinth disorders
Endocrine disorders

37

Eye disorders

60

25

Gastrointestinal disorders
General disorders and administration site…

72

16

Hepatobiliary disorders
Immune system disorders

53

Infections and infestations
Injury, poisoning and procedural complications

63
154

Investigations

42

Metabolism and nutrition disorders
Musculoskeletal and connective tissue…
Nervous system disorders

17
17

Pregnancy, puerperium and perinatal…
Product issues
Psychiatric disorders

29

Renal and urinary disorders
Reproductive system and breast disorders
Skin and subcutaneous tissue disorders
Surgical and medical procedures

67
84

0

Vascular disorders

126

53
58

Respiratory, thoracic and mediastinal disorders
Social circumstances

131

69

Neoplasms benign, malignant and…

177

68

148

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 has completed, as of MedDRA
Version 21.1, a review of terms translated from English into the supported MedDRA
languages, except Japanese. The list of terms updated will be available in theassociated 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 translation of a term or terms in any supported language, except
the Japanese translation of MedDRA.

What’s New MedDRA Version 21.1
September 2018
000224

3

New Developments in Version 21.1

3. NEW DEVELOPMENTS IN VERSION 21.1

3.1

STANDARDISED MedDRA QUERIES (SMQs)

No new SMQs were introduced into MedDRA Version 21.1, but there were 307
approved changes to existing SMQs. To view changes to existing SMQs, please review
the MedDRA Version 21.1 Version Report.

3.2

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 21.1 change request processing period, the MSSO reviewed four
requests and implemented three of them. See below for details. The MSSO publishes
and updates a list of all proposals received and their status 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.
3.2.1 Differentiation Between Administration Errors / Issues and Medication
Errors / Product Use Issues
A MedDRA user proposed improving the differentiation between administration
errors/issues and medication errors/product use issues on the LLT and PT level. The
MSSO performed a careful review of “administration” and “use” terms in HLGT
Medication errors and other product use errors and issues and made four changes forbetter alignment and consistency of placement. These include placing “unapproved use”
concepts under PT Product use issue because the main concept is the unapproved use,rather than an administration error/issue. In addition, the concepts of discontinued,
expired, recalled, counterfeit products being administered are all to be represented at
the PT level to facilitate retrieval and analysis because they are potentially importantsafety issues. The changes, which were implemented in MedDRA version 21.1,
included moving two LLTs, adding a new PT and promoting an LLT to the PT level. See
the table below for details.

What’s New MedDRA Version 21.1
September 2018
0002244

New Developments in Version 21.1

Moved LLT

From PT

To PT

Drug use inunapproved age
group

Drug administered topatient of inappropriate
age

Product use issue

Recalled drug
administered

Product use issue

Recalled productadministered*

PT

HLT

Primary SOC

Discontinued productadministered+

Product administration
errors and issues

Injury, poisoning andprocedural complications

Recalled productadministered*

Product administration
errors and issues

Injury, poisoning andprocedural complications

Table 3-1 Updates to “Administration” and “Use” Terms*New PT for MedDRA Version 21.1
+Promoted LLT

3.2.2

Prophylaxis Terms

The MSSO assessed the placement of existing prophylaxis/prevention terms in HLTProphylactic procedures NEC and moved them to more specific HLTs to optimize theirplacement in MedDRA as part of a proactive review requested by a MedDRA User. The
MSSO generally refrains from adding a new prophylaxis term for every specific medical
disorder represented in MedDRA because an overwhelmingly large number of suchpotential terms would likely result. However, on the basis of this review, new terms wereadded that represent prophylaxis and prevention concepts pertaining to generaldisorder/disease categories. A total of 70 changes were made including the addition of
17 new terms and moving 53 existing terms. See below for examples.
New PT

HLT

Primary SOC

Gastrointestinal
disorder prophylaxis

Gastrointestinal
therapeutic procedures
NEC

Surgical and medical
procedures

Eye disorderprophylaxis

Eye therapeutic
procedures NEC

Surgical and medical
procedures

Skin disorderprophylaxis

Skin and subcutaneous
tissue therapeutic
procedures NEC

Surgical and medical
procedures

What’s New MedDRA Version 21.1
September 2018
000224

5

New Developments in Version 21.1

Moved PT

From HLTTo HLT*

Antibiotic prophylaxis

Prophylactic procedures
NEC

Antiinfective therapies

Dental disorderprophylaxis

Prophylactic procedures
NEC

Dental and gingival
therapeutic procedures

Migraine prophylaxis

Prophylactic proceduresNEC

Nervous systemtherapeutic procedures
NEC

Table 3-2 New Prophylaxis Terms and Existing Term Change Examples*Moved PTs are primary to SOC Surgical and medical procedures

3.2.3 LLTs Under PT Procedural complication
The MSSO performed a proactivity review of all LLTs under PT Procedural complicationin SOC Injury, poisoning and procedural complications and made changes to alignthese terms to a more anatomically appropriate placement by moving them to an
existing PT or under a new PT. These changes were based on a suspended request to
promote LLT Intraoperative neurological injury from PT Procedural complication. A totalof 37 changes were made which included moving existing LLTs and the addition of 13
PTs. See the table below for examples.
Moved LLT

From PT

To PT

Intraoperative breast
injuryProcedural complication

Breast procedural
complication*

Intraoperative cardiac
injuryProcedural complication

Cardiac procedurecomplication

Intraoperative
neurological injury

Procedural complication

Neurological procedural
complication*

Intraoperative splenic
injuryProcedural complication

Spleen procedural
complication*

Table 3-3 Examples of LLTs Moved from PT Procedural complication*New PT primary to SOC Injury, poisoning and procedural complications

What’s New MedDRA Version 21.1
September 2018
0002246

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 21.1. These tables are intended only as a reference. For detailed information on
the changes to Version 21.1, please see the MedDRA Version Report included within
the MedDRA download.
SOC, HLGT, HLT Changes
Level

Change Request Action Net Change v21.0 v21.1

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

1,737

1,737

HLGT

HLT

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

MedDRA v21.1 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.
Total net change of HLGTs or HLTs equals the number of new HLGTs or HLTs minus
the number of respective merged HLGTs or HLTs.
1What’s New MedDRA Version 21.1
September 2018
0002247

Summary of Changes

PT Changes
Level Change Request Action

PT

v21.0

v21.1

New PTs342

347

Promoted LLTs

25

19

Demoted PTs

53

65

Net Change1

314

301

Total PTs

23,08823,389

Table 4-2 Summary of Impact on PTs

Net change of PTs equals the number of new PTs plus the number of promoted LLTs
minus the number of demoted PTs.

1

LLT Changes
Level

Currency Status

Net Change

v21.0

v21.1

LLT

Current Terms

698

69,531

70,229LLT

Non-current Terms

1

9,277

9,278

LLT

Total LLTs1

699

78,80879,507

Table 4-3 Summary of Impact on LLTs

1

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

What’s New MedDRA Version 21.1
September 2018
0002248

Summary of Changes

New SMQs
Level Net Change

v21.0

v21.1

1

0

103

103

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 21.1. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC
HLT.ASC
What’s New MedDRA Version 21.1
September 2018
000224Added

0Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0
9

Summary of Changes

HLT_PT.ASC

MDHIER.ASC

PT.ASC

LLT.ASC

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Removed0Modified

0

Added

653

Removed158

Modified

0

Added

711

Removed173

Modified

0

Added

366

Removed65

Modified

7

Added

699

Removed0Modified341

Added10Removed0Modified

223

Added

604

Removed0Modified

96

Table 4-5 Summary of Impact on Records in MedDRA Files1

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. Note that the number of LLTs also includes
PTs.

SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Blood andlymphatic systemdisorders

1,149

293

4,302

1,026

What’s New MedDRA Version 21.1
September 2018
000224

HLTs3 HLGTs3

88

17

10

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2Cardiac disorders

1,467

348

2,403

622

36

10

Congenital,familial andgenetic disorders

3,635

1,406

3,635

1,406

98

19

Ear and labyrinth
disorders

439

92

834

217

17

6

Endocrine
disorders

678

190

1,828

556

38

9

Eye disorders

2,488

618

3,800

1,045

63

13

Gastrointestinal
disorders

3,880

871

7,638

1,737

108

21

General disordersandadministration site
conditions

2,500

1,010

3,381

1,330

36

7

Hepatobiliary
disorders

666

200

1,493

438

19

4

Immune systemdisorders

493

145

2,687

732

26

4

Infections andinfestations

7,252

1,972

7,611

2,073

149

12

Injury, poisoning
and procedural
complications

6,746

1,221

9,430

2,391

78

9

Investigations

13,8285,730

13,828

5,730

106

23

What’s New MedDRA Version 21.1
September 2018
000224

HLTs3 HLGTs3

11

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2Metabolism andnutrition disorders

968

285

2,724

788

63

14

Musculoskeletaland connective
tissue disorders

2,611

464

6,648

1,315

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,621

1,978

9,396

2,293

202

39

Nervous systemdisorders

3,665

969

7,327

1,983

107

20

Pregnancy,
puerperium andperinatalconditions

1,636

225

2,922

602

48

8

Product issues

653

157

670

165

21

2

Psychiatricdisorders

2,370

528

3,246

786

76

23

Renal and urinary
disorders

1,232

356

2,640

748

32

8

Reproductive
system andbreast disorders

1,757

492

4,257

1,190

52

16

Respiratory,
thoracic andmediastinal
disorders

1,736

534

4,283

1,161

49

12

Skin andsubcutaneous
tissue disorders

2,124

510

4,861

1,401

56

10

What’s New MedDRA Version 21.1
September 2018
000224

HLTs3 HLGTs3

12

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2Socialcircumstances

640

273

640

273

20

7

Surgical andmedicalprocedures

4,924

2,211

4,924

2,211

141

19

Vasculardisorders

1,349

311

6,797

1,652

68

11

Total

79,507

23,389SOC

HLTs3 HLGTs3

Table 4-6 MedDRA Term Counts

Primary 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.
1

Total 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.
2

The HLT and HLGT counts are not necessarily unique values given MedDRA’s multiaxiality (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.
3

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.

What’s New MedDRA Version 21.1
September 2018
00022413

Summary of Changes

The table below summarizes terms modified in English MedDRA Version 21.1.
Code

Level

Term Name in v21.0

Term Name in v21.1

10023327

LLT

Keilland's forceps delivery

Kielland's forceps delivery

10031160

LLT

Osteo-arthritis of neck

Osteoarthritis of neck

10081096

LLT

Thoracic facet arthosis

Thoracic facet arthrosis

Table 4-7 Modified PT/LLT Names

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects one term at the LLT level in MedDRA Version 21.1 that hada change in currency status along with the rationale for the change.

Lowest Level Term

Hutchison's melanotic
freckleCurrency
StatusChanged to

Rationale

Non-current

LLT Hutchison's melanotic freckle is misspelled and waschanged to a status of non-current. The correctly spelled
LLT Hutchinson's melanotic freckle is an existing term in
MedDRA.

Table 4-8 LLT Currency Changes

What’s New MedDRA Version 21.1
September 2018
00022414