C

What’s New
MedDRA Version 23.1

September 2020
000488

Acknowledgements

ACKNOWLEDGEMENTS
MedDRA® trademark is registered by 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 thedocument 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 23.1
September 2020
000488ii

Table of Contents

Table of Contents
1.

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

2.

VERSION 23.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2

3.

NEW DEVELOPMENTS IN VERSION 23.1 ........................................................... 4
3.1 UPDATES TO COVID-19 TERMS .................................................................... 43.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 43.3 PROACTIVITY REQUESTS ............................................................................. 5
3.4 MedDRA APPLICATION PROGRAM INTERFACES........................................ 54.

SUMMARY OF CHANGES ..................................................................................... 64.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ......................................... 6
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ........................... 84.3 MedDRA TERM COUNTS ................................................................................ 94.4 MODIFIED PT AND LLT NAMES ................................................................... 124.5 LLT CURRENCY STATUS CHANGES ........................................................... 13

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
LIST OF TABLES
Table 3-1 New COVID-19 Term Examples.......................................................... 4
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs ...................................... 6
Table 4-2 Summary of Impact on PTs ................................................................. 7
Table 4-3 Summary of Impact on LLTs ............................................................... 7
Table 4-4 Summary of Impact on SMQs ............................................................. 8
Table 4-5 Summary of Impact on Records in MedDRA Files .............................. 9
Table 4-6 MedDRA Term Counts ...................................................................... 12
Table 4-7 Modified PT/LLT Names .................................................................... 12
Table 4-8 LLT Currency Changes ..................................................................... 13

What’s New MedDRA Version 23.1
September 2020
000488iii

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
23.0 and 23.1.
Section 2, Version 23.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 23.1, highlights changes in Version 23.1
related to change request submissions, new initiatives, information on Standardised
MedDRA Queries (SMQs), and any recent updates to software tools provided by theMSSO.
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 23.1
September 2020
0004881

Version 23.1 Change Requests

2. VERSION 23.1 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 23.1 is a simple change version which means that changes are madeat the PT and LLT level only.
Change requests involve both MedDRA updates and SMQ changes. There was a totalof 1,541 change requests processed for this version; 1,182 change requests wereapproved and implemented, and 351 change requests were not approved. There are, inaddition, 8 change requests suspended for further consideration and resolution beyond
this version.
Information on specific changes (e.g., new terms added, LLT promotions, PTdemotions, 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 theVersion 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. Additionally, supplemental changes may be viewed in MedDRA Web-BasedBrowser via the “supplemental view” feature. Supplemental information may be helpfulfor 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 23.1 is accessible as a cumulative Detail Report included in the MedDRA
English version download. Users may review all change requests considered by theMSSO 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 ofMedDRA. The data are derived from the difference in counts of primary and secondary
PT/LLTs, HLTs, and HLGTs for Version 23.1 (shown in Table 4-6) and thecorresponding information for Version 23.0. 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 23.1.

What’s New MedDRA Version 23.1
September 2020
0004882

Version 23.1 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 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…
Nervous system disorders
Pregnancy, puerperium and perinatal conditions
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
2
Surgical and medical procedures
Vascular disorders

29381511713297938287994123137257747843352321524576997110

Figure 2-1 Net Changes of Terms per SOC

What’s New MedDRA Version 23.1
September 2020
0004883

New Developments in Version 23.1

3. NEW DEVELOPMENTS IN VERSION 23.1
3.1

NEW COVID-19 TERMS AND CHANGESIn April 2020, the MSSO re-released MedDRA Version 23.0 to include COVID-19
related terms and revisions. The MSSO continued to add new COVID-19 related terms
in MedDRA Version 23.1 based upon MedDRA user requests. Over 50 new COVID-19
related LLTs/PTs were added. See the table below for several examples:
LLTPT

HLT

Primary SOC

COVID-19 aggravated

COVID-19

Coronavirus
infections

Infections andinfestations

Multisystem inflammatory
syndrome in children

Multisystem
inflammatory
syndrome in children

Immune andassociatedconditions NECImmune systemdisorders

SARS-CoV-2 sepsis

SARS-CoV-2 sepsis

Coronavirus
infections

Infections andinfestations

SARS-CoV-2 molecular
test positive

SARS-CoV-2 test
positive

Virus identificationand serology

Investigations

SARS-CoV-2 IgG
antibody test

SARS-CoV-2antibody test

Virus identificationand serology

Investigations

Drug shortage due topandemic

Product availabilityissue

Product supply andavailability issues

Product issues

Table 3-1 New COVID-19 Related Term Examples

Additionally, LLT SARS-CoV-2 antibody test, LLT SARS-CoV-2 antibody test negativeand SARS-CoV-2 antibody test positive were promoted to the PT level and appropriate“antibody test” terms were moved under these PTs. These changes allow the distinction
to be made at the PT level between viral (diagnostic) tests for active infection (e.g.,SARS CoV-2 test) and antibody (serology) tests for previous infection (e.g., SARS-CoV2 antibody test).
3.2

STANDARDISED MedDRA QUERIES (SMQs)

Two new SMQs have been added for MedDRA Version 23.1 - SMQ Immunemediated/autoimmune disorders and SMQ COVID-19. There are now 108 level 1 SMQs
in production as of this version. In addition, there were 296 approved PT changes toexisting SMQs. To view changes to existing SMQs, please review the MedDRA Version23.1 Version Report.
Please see the MedDRA Version 23.1 SMQ Introductory Guide for detailed information
on new SMQ Immune-mediated/autoimmune disorders and SMQ COVID-19.
What’s New MedDRA Version 23.1
September 2020
0004884

New Developments in Version 23.1

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 23.1 change request processing period, there were no open or
implemented proactivity requests. The MSSO publishes and updates a list of all
proposals received and their status on the Change Request section of the MedDRAwebsite.
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.
3.4

MedDRA APPLICATION PROGRAM INTERFACES

In October of 2020, the MSSO expects to deploy a set of MedDRA application programinterfaces (APIs) that may be used by subscribing organizations. The MedDRA APIs
were developed in response to user requests and provide similar features as the WebBased Browser and MedDRA Version Analysis Tool. These features include browsing
and searching for MedDRA terms and SMQs, term detail information, term history,
hierarchy and SMQ analysis and data impact and version report information.
The MedDRA APIs are an open software model which allow users more flexibility indeveloping their own MedDRA tools or extending existing tools. The APIs accurately
depict MedDRA and deliver access to all MedDRA versions and MedDRA translations.
Presently the MedDRA APIs are in a user evaluation period until October 2020. For
further information, including detailed documentation on the APIs, please go to the API
section of the MedDRA website.

What’s New MedDRA Version 23.1
September 2020
0004885

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 inVersion 23.1. These tables are intended only as a reference. For detailed information on
the changes to Version 23.1, please see the MedDRA Version Report included within
the MedDRA download or in MVAT. Note that the Version 23.0 numbers below areinclusive of the 83 COVID-19 new terms and changes deployed in April of 2020.
SOC, HLGT, HLT Changes
Level

Change Request Action Net Change v23.0 v23.1

SOCTotal SOCs

02727

New HLGTs

010Merged HLGTs

010Total HLGTs10337

337

New HLTs

040Merged HLTs

030Total HLTs101,738

1,738

HLGTHLT

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

MedDRA v23.1 is a simple change version which means changes are only made at thePT and LLT levels of the MedDRA hierarchy; hence there are no changes in the numberof 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.

What’s New MedDRA Version 23.1
September 2020
000488

6Summary of Changes

PT Changes
Level Change Request ActionPTv23.0

v23.1

New PTs370274

Promoted LLTs

47

15

Demoted PTs

5831

Net Change1

359

258

Total PTs

24,313

24,571

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

Currency Status

Net Change

v23.0

v23.1

LLT

Current Terms

697

72,58773,284

LLT

Non-current Terms

19,2989,299

LLT

Total LLTs1

698

81,88582,583

Table 4-3 Summary of Impact on LLTs

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

New SMQs
Level Net Change

v23.0

v23.1

12106108208282

302020What’s New MedDRA Version 23.1
September 2020000488

7

Summary of Changes

Level Net Change

v23.0

v23.1

4016165022

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 23.1. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

HLT_PT.ASC

MDHIER.ASC

What’s New MedDRA Version 23.1
September 2020
000488Added

0Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

474

Removed59

Modified

0

Added

508

Removed71

Modified08Summary of Changes

PT.ASC

LLT.ASC

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added

289

Removed31

Modified

4

Added

698

Removed0Modified

191

Added1

2

Removed0Modified

226

Added

3,027

Removed0Modified

136

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. Note that the number of LLTs also includes
PTs.
LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Blood andlymphatic systemdisorders

1,197

303

4,431

1,061

88

17Cardiac disorders

1,508

368

2,486

656

36

10Congenital,familial andgenetic disorders4,136

1,647

4,136

1,647

100

19

Ear and labyrinth
disorders

445

95

885

230

17

6

SOC

What’s New MedDRA Version 23.1
September 2020
000488

HLTs3 HLGTs3

9

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Endocrine
disorders

692

195

1,898

578

38

9

Eye disorders

2,549

645

3,950

1,103

63

13

Gastrointestinal
disorders

4,008

919

7,830

1,817

105

21

General disorders
andadministration site
conditions

2,473

1,000

3,420

1,348

35

7

Hepatobiliary
disorders

699

216

1,547

461

19

4

Immune systemdisorders

537

154

2,891

809

26

4

Infections andinfestations

7,443

2,056

7,844

2,173

150

12

Injury, poisoning
and procedural
complications

6,978

1,294

9,823

2,548

78

9

Investigations

14,2495,950

14,249

5,950

106

23

Metabolism andnutrition disorders

998

297

2,861

835

63

14

Musculoskeletaland connective
tissue disorders

2,684

492

6,905

1,427

59

11

Neoplasms
benign, malignant
and unspecified

8,756

2,007

9,573

2,336

202

39

SOC

What’s New MedDRA Version 23.1
September 2020
000488

HLTs3 HLGTs310Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Nervous systemdisorders

3,824

1,021

7,662

2,124

108

20

Pregnancy,
puerperium andperinatal
conditions

1,676

239

3,001

648

48

8

Product issues

864

173

883

182

21

2

Psychiatricdisorders

2,406

551

3,368

844

77

23

Renal and urinary
disorders

1,267

374

2,711

785

32

8

Reproductive
system andbreast disorders

1,811

512

4,414

1,243

52

16

Respiratory,
thoracic andmediastinal
disorders

1,818

569

4,446

1,225

4912

Skin andsubcutaneous
tissue disorders

2,211

536

5,638

1,494

56

10

Socialcircumstances

650

280

650

280

207

Surgical andmedicalprocedures

5,299

2,347

5,299

2,347

141

19

Vasculardisorders

1,405

331

7,112

1,768

68

11

SOC

HLTs3 HLGTs3(incl cysts andpolyps)

What’s New MedDRA Version 23.1
September 2020
00048811

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

Total

82,583

24,571

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

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 oftotal 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 HLTsand 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 bemodified (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 summarizes terms modified in English MedDRA Version 23.1.
Code10081385

Level
PT

Term Name in v23.0
Hepatobilliary disorderprophylaxis

Term Name in v23.1
Hepatobiliary disorderprophylaxis

Table 4-7 Modified PT/LLT Names

What’s New MedDRA Version 23.1
September 2020000488

12Summary of Changes

4.5LLT CURRENCY STATUS CHANGESThe following table reflects one term at the LLT level in MedDRA Version 23.1 that hada change in currency status along with the rationale for the change.

Lowest Level Term

Platelet aggregation

CurrencyStatus
Changed toRationale

Non-current

PT Platelet aggregation was demoted under new PT
Platelet aggregation test and its status was changed to
non-current. The concept is ambiguous as it could
convey a test or an abnormality.

Table 4-8 LLT Currency Changes

What’s New MedDRA Version 23.1
September 2020
00048813