C

What’s New
MedDRA Version 26.1

September 2023
000980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 26.1
September 2023
000980ii

Table of Contents

TABLE OF CONTENTS
1.

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

2.

VERSION 26.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2

3.

NEW DEVELOPMENTS IN VERSION 26.1 ........................................................... 4
3.1 ICD-10 TO MedDRA MAPPING........................................................................ 43.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 43.3 PROACTIVITY REQUESTS ............................................................................. 4
3.4 NEW MedDRA LANGUAGES DEPLOYED AND UNDER DEVELOPMENT .... 54.

SUMMARY OF CHANGES ..................................................................................... 64.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ......................................... 6
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ........................... 7
4.3 MedDRA TERM COUNTS BY SOC.................................................................. 84.4 LLT CURRENCY STATUS CHANGES ........................................................... 12

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
LIST OF TABLES
Table 4-1 MedDRA Term File Counts .................................................................. 6
Table 4-2 Summary of Impact on LLTs ................................................................ 7
Table 4-3 Summary of Impact on SMQs .............................................................. 7
Table 4-4 Summary of Impact on Records in MedDRA Files ............................... 8
Table 4-5 MedDRA Term Counts by SOC.......................................................... 11
Table 4-6 LLT Currency Changes ...................................................................... 12

What’s New MedDRA Version 26.1
September 2023
000980iii

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
26.0 and 26.1.
Section 2, Version 26.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 26.1, highlights changes in Version 26.1
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•

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 mssohelp@meddra.org.

What’s New MedDRA Version 26.1
September 2023
0009801

Version 26.1 Change Requests

2. VERSION 26.1 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 groupactivities in which the MSSO participates.
MedDRA Version 26.1 is a simple change version which means changes are made at
the PT and LLT level of the MedDRA hierarchy only.
Change requests involve both MedDRA updates and SMQ changes. There was a totalof 1,605 change requests processed for this version; 1,359 change requests wereapproved and implemented, and 241 change requests were not approved. There are, inaddition, five 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 MedDRAdownload. 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 identical to theVersion Report provided in the MedDRA zip file download. MVAT is provided free ofcharge to MedDRA users as part of their subscription.
Between MedDRA releases, the MSSO makes available English weekly supplemental
update files, which are approved changes that will be implemented for the next
MedDRA version. Additionally, supplemental changes may be viewed in the MedDRA
Web-Based Browser or MVAT via the “supplemental view” feature. Supplemental
information may be helpful for users to identify changes that will be implemented in thenext release.
An explanation of all changes considered (approved and not approved) for MedDRA
Version 26.1 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 26.1 (shown in Table 4-5) and thecorresponding information for Version 26.0. Additionally, LLT currency status changes
are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA Version 26.1.

What’s New MedDRA Version 26.1
September 2023
0009802Version 26.1 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

37968110273176

1916773579959725677110

27241538
4713058112245

Figure 2-1 Net Changes of Terms per SOC

What’s New MedDRA Version 26.1
September 2023
0009803Summary of Changes

3. NEW DEVELOPMENTS IN VERSION 26.1
3.1

ICD-10 TO MedDRA MAPPINGThe MSSO is pleased to announce the availability of the ICD-10 to MedDRA unidirectional mapping. The mapping was developed in a collaboration between the World
Health Organization (WHO) and the International Council for Harmonisation (ICH) withMSSO supporting this effort. The ICD-10 to MedDRA uni-directional mapping isavailable from the Downloads page (MedDRA ID and password required) of theMedDRA website. The release package includes a spreadsheet with the mapping and amapping convention document that describes how the mapping was developed. Themap will continue to be updated to the latest release of MedDRA.
WHO and ICH with MSSO supporting, plan to continue their joint activities to develop bidirectional ICD-11 – MedDRA mappings. These mappings will support theinteroperability between ICD-10/11 data that provides critical knowledge on the extent,causes and consequences of human disease and death worldwide with MedDRA thatfacilitates global regulatory decision making on the safety and efficacy of medicinalproducts. These mappings will extend the utility of both ICD-10/11 and MedDRA
through a much broader access to data coded in both terminologies. The specificrelease date of the ICD-11 – MedDRA mappings is yet to be determined.
WHO and ICH plan to maintain the mappings based on user feedback as well aschanges in the underlying terminologies. This will ensure the utility of the maps as
medicine continues to evolve.
For any questions, please contact the MSSO Help Desk at mssohelp@meddra.org.
3.2

STANDARDISED MedDRA QUERIES (SMQs)

No new SMQs have been added for MedDRA Version 26.1. There were 311 approved
PT changes to existing SMQs. To view changes to existing SMQs, please review theMedDRA Version 26.1 Version Report.

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 26.1 change request processing period, there were no implemented
proactivity requests. 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 yourWhat’s New MedDRA Version 26.1
September 2023
0009804

Summary of Changes

suggestion(s) and include a justification which explains why you think your proposal
should be implemented.

3.4

NEW MedDRA LANGUAGES DEPLOYED AND UNDER DEVELOPMENTThe MSSO continues to work on new languages to enable more users to apply
MedDRA in their native language and facilitate global communication of MedDRA coded
data. The newest available language is Estonian.
Estonian is part of the 17 European Economic Area (EEA) official languages, approvedby the MedDRA Management Committee in 2020, which are needed to support theelectronic product information initiative. Note that this initiative includes the translationof MedDRA terms only and does not include MedDRA user documentation.
Presently, Croatian, Finnish, Icelandic, Lithuanian, Maltese, Norwegian, and Sloveniantranslations are in development. The remaining languages in the EEA region will betranslated and made available in 2024 or by early 2025. Please see the multilingual
access section of the MedDRA Home page for the list of currently supported languages.
The MSSO will provide estimated release dates for these languages as they become
available.

What’s New MedDRA Version 26.1
September 2023
0009805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 26.1. For detailed information on the changes to Version 26.1, please see theMedDRA Version Report in MVAT.
Number ofRecords in
V26.0

Number ofRecords inV26.1

Changehlgt.asc

337

3370

hlgt_hlt.asc

1,755

1,7550hlt.asc

1,737

1,737

0

hlt_pt.asc

37,98438,380396

llt.asc

86,71487,592878

meddra_history_english.asc

135,727

136,994

1,267

1

10

mdhier.asc

40,18740,613426

pt.asc25,91626,180264

soc.asc27

27

0

soc_hlgt.asc

354

354

0

intl_ord.asc

27

27

0

smq_list.asc

230

230

0

smq_content.asc

93,78594,737952

File Namemeddra_release.asc

Table 4-1 MedDRA Term File Counts

The MedDRA history and release files are optional files for use with the MedDRA
Desktop Browser (MDB) release 3.0.2 Beta and up. These files are not part of theMedDRA schema.

What’s New MedDRA Version 26.1
September 2023
0009806Summary of Changes

The table below identifies the number of current vs. non-current terms.
LLT Changes
Level

Currency Status

v26.0

v26.1

LLTCurrent Terms

77,40878,283

LLT

Non-current Terms

9,306

9,309

LLT

Total LLTs1

86,71487,592

Table 4-2 Summary of Impact on LLTs
1Total LLTs include PTs as they are also in the LLT distribution file.

New SMQs
Level Net Changev26.0v26.1

10110110208282

3020204016165022Table 4-3 Summary of Impact on SMQs

4.2

SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES

The table below lists the consecutive files, associated MedDRA tables and the numberof records contained in each consecutive file. A zero indicates that the file has notchanged since the prior consolidated MedDRA release. The table below summarizes
the impact on MedDRA in Version 26.1. Please see the MedDRA Version Report inMVAT for details.

What’s New MedDRA Version 26.1
September 2023
0009807Summary of Changes

Number ofRecords in Table

File Name
hlgt.seq0

hlgt_hlt.seq

0hlt.seq0

hlt_pt.seq

586

llt.seq

1,069

mdhier.seq

650

pt.seq355

soc.seq0

soc_hlgt.seq

0

intl_ord.seq

0Table 4-4 Summary of Impact on Records in MedDRA Files

4.3

MedDRA TERM COUNTS BY SOC

The table below shows term counts by SOC for HLGTs, HLTs, primary and secondaryPTs and LLTs, and primary PTs and LLTs. Note that the number of LLTs also includes
PTs.

SOC

LLTs(Primary)1PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Blood andlymphatic systemdisorders

1,262

332

4,644

1,149

87

17

Cardiac disorders

1,595

388

2,659

705

36

10

What’s New MedDRA Version 26.1
September 2023
000980

HLTs3 HLGTs38

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2PTs(Primary andSecondary)2

Congenital,familial andgenetic disorders

4,513

1,810

4,513

1,810

100

19Ear and labyrinth
disorders

464

104

933

248

17

6

Endocrine
disorders

746

209

2,031

621

38

9

Eye disorders

2,718

684

4,165

1,175

63

13

Gastrointestinal
disorders

4,240

985

8,238

1,945

105

21

General disorders
andadministration site
conditions

2,589

1,029

3,621

1,416

35

7

Hepatobiliary
disorders

743

227

1,635

485

19

4

Immune systemdisorders

602

175

3,230

916

26

4

Infections andinfestations

7,786

2,180

8,238

2,313

150

12

Injury, poisoning
and procedural
complications

7,294

1,396

10,479

2,758

78

9

Investigations

15,051

6,289

15,051

6,289

106

23

Metabolism andnutrition disorders

1,051

309

3,100

902

63

14

What’s New MedDRA Version 26.1
September 2023
000980

HLTs3 HLGTs3

9

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Musculoskeletaland connective
tissue disorders

2,836

525

7,260

1,530

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

9,079

2,115

9,980

2,473

201

39

Nervous systemdisorders

4,098

1,118

8,226

2,308

108

20

Pregnancy,
puerperium andperinatalconditions

1,725

253

3,123

689

48

8

Product issues

923

180

954

194

21

2

Psychiatricdisorders

2,492

571

3,528

884

77

23

Renal and urinary
disorders

1,312

387

2,829

820

32

8

Reproductive
system andbreast disorders

1,886

542

4,603

1,326

52

16

Respiratory,
thoracic andmediastinal
disorders

1,939

599

4,715

1,311

49

12

Skin andsubcutaneous
tissue disorders

2,381

576

6,033

1,605

56

10

Socialcircumstances

685

296

685

296

20

7

What’s New MedDRA Version 26.1
September 2023
000980

HLTs3 HLGTs3

10

Summary of Changes
LLTs(Primary)1PTs(Primary)1

LLTs(Primary andSecondary)2PTs(Primary andSecondary)2Surgical andmedicalprocedures

6,115

2,556

6,115

2,556

141

19

Vasculardisorders

1,467

345

7,542

1,889

68

11

Total

87,592

26,180SOC

HLTs3 HLGTs3

Table 4-5 MedDRA Term Counts by SOC

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 4-1 and 4-2.
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 4-1 and 4-2.

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.

What’s New MedDRA Version 26.1
September 2023
00098011

Summary of Changes

4.4

LLT CURRENCY STATUS CHANGESThe following table reflects three terms at the LLT level in MedDRA Version 26.1 that
had a change in currency status along with the rationale for the changes.

Lowest Level Term

Peritoneal washing

Post MIRACurrencyStatus
Changed toRationale

Non-current‘Peritoneal washing’ and ‘peritoneal lavage’ are twodifferent concepts. However, lavage and washing could
be misinterpreted as synonyms. Therefore, a new PTPeritoneal washing cytology was added to HLT
Gastrointestinal histopathology procedures todifferentiate it from existing PT Peritoneal lavage. As aresult of this change, existing PT Peritoneal washing
was demoted to an LLT under the new PT Peritoneal
washing cytology, and the status of LLT Peritoneal
washing was changed to non-current to avoid thisconfusion.

Non-current

MI is ambiguous abbreviation as it may refer to different
concepts such as mitral incompetence, myocardial
infarction or myocardial ischemia.

Non-current

The acronym RA is ambiguous abbreviation as it may
refer to reactive arthritis, refractory anemia, orrheumatoid arthritis.

Table 4-6 LLT Currency Changes

What’s New MedDRA Version 26.1
September 2023
00098012