C

What’s New
MedDRA Version 26.0

March 2023
000913

Acknowledgements

ACKNOWLEDGEMENTS
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What’s New MedDRA Version 26.0
March 2023
000913ii

Table of Contents

TABLE OF CONTENTS
1.

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

2.

VERSION 26.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 33.

NEW DEVELOPMENTS IN VERSION 26.0 ........................................................... 5
3.1 ADDITIONAL COVID-19 RELATED TERMS .................................................... 5
3.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 5
3.3 PROACTIVITY REQUESTS ............................................................................. 5
3.4 NEW MedDRA LANGUAGES DEPLOYED AND UNDER DEVELOPMENT .... 6
3.5 MedDRA APIs ................................................................................................... 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 BY SOC .................................................................. 9
4.4 LLT CURRENCY STATUS CHANGES ........................................................... 13

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
LIST OF TABLES
Table 2-1 New HLTs ............................................................................................ 4
Table 2-2 Merged HLTs........................................................................................ 4
Table 3-1 COVID-19 Term Examples ................................................................... 5
Table 4-1 MedDRA Term File Counts .................................................................. 7
Table 4-2 Summary of Impact on LLTs ................................................................ 8
Table 4-3 Summary of Impact on SMQs .............................................................. 8
Table 4-4 Summary of Impact on Records in MedDRA Files ............................... 9
Table 4-5 MedDRA Term Counts by SOC.......................................................... 12
Table 4-6 LLT Currency Changes ...................................................................... 13

What’s New MedDRA Version 26.0
March 2023
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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
25.1 and 26.0.
Section 2, Version 26.0 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 26.0, highlights changes in Version 26.0
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•

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 26.0
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Version 26.0 Change Requests

2. VERSION 26.0 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 26.0 is a complex change version which means changes may bemade at any level of the MedDRA.
Change requests involve both MedDRA updates and SMQ changes. There was a totalof 1,912 change requests processed for this version; 1,585 change requests wereapproved and implemented, and 317 change requests were not approved. There are, in
addition, 10 change request 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 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 26.0 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 26.0 (shown in Table 4-5) and thecorresponding information for Version 25.1. Additionally, LLT currency status changes
are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA Version 26.0.

What’s New MedDRA Version 26.0
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Version 26.0 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

39

52
145
7
32
61
138
76
41
72
88

215
225
72
92
81
168
48
3
45
29

55
53
106
7
241
96

Figure 2-1 Net Changes of Terms per SOC

2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 26.0 included thosesubmitted by users, special initiatives, and those internally identified by the MSSO
during change request processing.
Complex change proposals were posted on the MedDRA website for feedback from the
MedDRA user community from 1 August 2022 to 23 September 2022. Complex
changes were followed by further internal review and consensus discussions which
resulted in the final approved set of 4 complex changes.
The complex changes implemented in Version 26.0 are summarized below. Please see
the “Related Documents” on the Change Request section of the MedDRA website for
specific details.

What’s New MedDRA Version 26.0
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Version 26.0 Change Requests

At the SOC level: No changes were made to existing SOCs.

At the HLGT level: No changes were made to existing HLGTs.
At the HLT level: There were two High Level Terms (HLTs) added and two HLTs
merged as a result of complex changes in Version 26.0.
The changes are as follows:
New HLTs
New HLTTo SOC

Fertility analyses and other reproductivefunction procedures

Investigations

Urinary tract lithiasis NEC

Renal and urinary disorders
Table 2-1 New HLTs

Merged HLTs
HLT

To HLT

SOC

Fertility analyses

Fertility analyses and otherreproductive function
procedures

Investigations

Urinary tract lithiasis (excl
renal)Urinary tract lithiasis NEC

Renal and urinary disorders

Table 2-2 Merged HLTs

What’s New MedDRA Version 26.0
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4

New Developments in Version 26.0

3. NEW DEVELOPMENTS IN VERSION 26.0
3.1

ADDITIONAL COVID-19 RELATED TERMS

The MSSO continued to add COVID-19 related terms in MedDRA Version 26.0 based
upon MedDRA user requests. A total of 8 new COVID-19 related terms were added
including terms related to vaccines which may be applicable in the context of COVID19.
See the table below for several examples:
LLT
COVID-19 breath test
Symptomatic COVID-19
Vaccine-vaccine
interaction

PT
COVID-19 breath
test

HLT
Virus identificationand serology

COVID-19

Coronavirus
infections

Vaccine interaction Interactions

Primary SOC
Investigations
Infections andinfestations
General disorders
and administrationsite conditions

Table 3-1 COVID-19 Term Examples

3.2

STANDARDISED MedDRA QUERIES (SMQs)

No new SMQs have been added for MedDRA Version 26.0. There were 342 approved
PT changes to existing SMQs. To view changes to existing SMQs, please review the
MedDRA Version 26.0 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 26.0 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 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.
What’s New MedDRA Version 26.0
March 2023
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5

New Developments in Version 26.0

3.4

NEW MedDRA LANGUAGES DEPLOYED AND UNDER DEVELOPMENT

The MSSO deployed the Arabic translation of MedDRA in January 2023 upon approvalof the MedDRA Management Committee. The Arabic translation of MedDRA includes
all MedDRA terms and all user documentation.
Additionally, the MSSO released the Greek and Polish translation of MedDRA in
November 2022. Greek and Polish are part of the 17 European Economic Area (EEA)
official languages, approved by the MedDRA Management Committee in 2020, which
are needed to support the electronic product information initiative. Note that thisinitiative includes the translation of MedDRA terms only and does not include MedDRA
user documentation.
Presently, Croatian, Estonian, Finnish, Icelandic, Lithuanian, Maltese, Norwegian, andSlovenian translations are in development. The remaining languages in the EEA region
will be translated and made available in 2024. Please see the multilingual accesssection 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.

3.5

MedDRA APIs

In the first quarter of 2023, the MSSO deployed a set of Application Program Interfaces(APIs) for use by the MedDRA user community. The MedDRA APIs are an open
software model, which accurately depicts MedDRA and provides access to all MedDRA
versions and MedDRA translations. Because the MedDRA APIs may be integrated withuser developed tools, some of which may be validated versus the MSSO’s othersoftware products which are used independently of a user’s tool, the MSSO hasdeveloped four APIs to Good practice (GxP) standards.
Additionally, the MSSO also operates a separate environment called the “Sandbox”
environment that contains additional APIs which are not maintained in a controlled GxPenvironment. MedDRA users may use the “Sandbox” environment to evaluate the APIs
or use them in non-GxP applications.
For specific details on the APIs, including programmer’s guides and documentation to
support GxP validation, please click “Login for detailed API information” under “related
documents” of the API section of the MedDRA website. A MedDRA user ID andsubscription password are required to access API information.
If you have a specific MedDRA API question, please contact our Help Desk and include
the subject of “APIs” in the subject line of the message.

What’s New MedDRA Version 26.0
March 2023
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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 26.0. For detailed information on the changes to Version 26.0, please see the
MedDRA Version Report in MVAT.
Number ofRecords in
V25.1

Number ofRecords in
V26.0

Changehlgt.asc

337

337

0

hlgt_hlt.asc

1,755

1,755

0

hlt.asc

1,737

1,737

0

hlt_pt.asc

37,46837,984516

llt.asc

85,66886,714

1,046

meddra_history_english.asc*

134,220

135,727

1,507

1

1

0

mdhier.asc

39,64740,187540

pt.asc25,592

25,916324

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

92,82593,785960

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 the
MedDRA schema.

What’s New MedDRA Version 26.0
March 2023
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Summary of Changes

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

Currency Status

v25.1

v26.0

LLT

Current Terms

76,364

77,408

LLT

Non-current Terms

9,304

9,306

LLT

Total LLTs1

85,66886,714

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

In MedDRA Version 26.0 the number of non-current LLTs is two more than the previous
version of MedDRA. This was due to two changes. An existing term, LLT Urine candida
was changed to a status of non-current. See section 4.4 of this document for an
explanation of this change. The second change was following the addition of new term
LLT Retrograde nephroureteral stent. Upon review, it was determined LLT Retrograde
nephroureteral stent did not properly capture the procedural aspect of the concept. To
clarify the nature of the concept, a new term LLT Retrograde nephroureteral stentplacement was added under PT Ureteral stent insertion. As a result, LLT Retrograde
nephroureteral stent was changed to a status of non-current. Since LLT Retrograde
nephroureteral stent was added as a non-current LLT in MedDRA Version 26.0, it will
not be listed in the Version Report or MVAT as a currency change.
New SMQs
Level Net Change

v25.1

v26.0

1

0

110

110

2

0

82

82

3

0

20

20

4

0

16

16

5

0

2

2

Table 4-3 Summary of Impact on SMQs
What’s New MedDRA Version 26.0
March 2023
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Summary of Changes

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 26.0. Please see the MedDRA Version Report in
MVAT for details.
File Name

Number ofRecords in Table

hlgt.seq0

hlgt_hlt.seq

4hlt.seq4

hlt_pt.seq

880

llt.seq

1,273

mdhier.seq

942

pt.seq461

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 secondary
PTs and LLTs, and primary PTs and LLTs. Note that the number of LLTs also includes
PTs.

What’s New MedDRA Version 26.0
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Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Blood andlymphatic systemdisorders

1,256

328

4,593

1,132

87

17

Cardiac disorders

1,591

388

2,631

697

36

10

Congenital,familial andgenetic disorders

4,440

1,775

4,440

1,775

100

19

Ear and labyrinth
disorders

458

103

926

246

17

6

Endocrine
disorders

729

204

2,013

614

38

9

Eye disorders

2,699

680

4,141

1,168

63

13

Gastrointestinal
disorders

4,209

976

8,180

1,926

105

21

General disordersandadministration site
conditions

2,569

1,026

3,607

1,411

35

7

Hepatobiliary
disorders

738

226

1,623

481

19

4

Immune systemdisorders

596

170

3,169

901

26

4

Infections andinfestations

7,736

2,165

8,162

2,292

150

12

Injury, poisoning
and procedural
complications

7,265

1,388

10,401

2,741

78

9

What’s New MedDRA Version 26.0
March 2023
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HLTs3 HLGTs3

10

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Investigations

14,8696,219

14,869

6,219

106

23

Metabolism andnutrition disorders

1,048

309

3,074

895

63

14

Musculoskeletaland connective
tissue disorders

2,818

524

7,198

1,516

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,993

2,087

9,882

2,441

201

39

Nervous systemdisorders

4,057

1,106

8,143

2,281

108

20

Pregnancy,
puerperium andperinatalconditions

1,722

252

3,118

687

48

8

Product issues

915

180

945

194

21

2

Psychiatricdisorders

2,484

568

3,509

876

77

23

Renal and urinary
disorders

1,305

386

2,809

815

32

8

Reproductive
system andbreast disorders

1,874

540

4,576

1,315

52

16

Respiratory,
thoracic andmediastinal
disorders

1,922

596

4,679

1,300

49

12

SOC

What’s New MedDRA Version 26.0
March 2023
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HLTs3 HLGTs3

11

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2Skin andsubcutaneous
tissue disorders

2,361

574

5,985

1,597

56

10

Socialcircumstances

677

289

677

289

20

7

Surgical andmedicalprocedures

5,940

2,516

5,940

2,516

141

19

Vasculardisorders

1,443

341

7,458

1,862

68

11

Total

86,71425,916

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 of
total 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 HLTs
and HLGTs are greater than those found in Table 4-1.

What’s New MedDRA Version 26.0
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Summary of Changes

4.4

LLT CURRENCY STATUS CHANGESThe following table reflects one term at the LLT level in MedDRA Version 26.0 that hada change in currency status along with the rationale for the change.

Lowest Level TermUrine candida

Currency
StatusChanged to

Rationale

Non-current

The expression "Urine candida" is ambiguous as it canrefer to an Investigation or Positive Test result. The
existing LLT Candiduria may be considered for coding
purposes.

Table 4-6 LLT Currency Changes

Note: Since the term LLT Retrograde nephroureteral stent was added as a non-current
LLT in MedDRA 26.0, it will not be listed in the Version report or MVAT as a currencychange. See section 4.1 of this document for the explanation of this change.

What’s New MedDRA Version 26.0
March 2023
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