C

What’s New
MedDRA Version 25.1

September 2022
000799

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 25.1
September 2022
000799ii

Table of Contents

TABLE OF CONTENTS
1.

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

2.

VERSION 25.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2

3.

NEW DEVELOPMENTS IN VERSION 25.1 ........................................................... 4
3.1 ADDITIONAL COVID-19 RELATED TERMS .................................................... 43.2 STANDARDISED MEDDRA QUERIES (SMQS) .............................................. 43.3 PROACTIVITY REQUESTS ............................................................................. 43.4 NEW MEDDRA LANGUAGES DEPLOYED AND UNDER DEVELOPMENT ... 5
3.5 MEDDRA SELF-SERVICE APPLICATION UPDATE ....................................... 54.

SUMMARY OF CHANGES ..................................................................................... 74.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ......................................... 74.2 SUMMARY OF IMPACT ON RECORDS IN MEDDRA FILES .......................... 84.3 MEDDRA TERM COUNTS BY SOC................................................................. 94.4 LLT CURRENCY STATUS CHANGES ........................................................... 12

LIST OF FIGURESFigure 2-1 Net Changes of Terms per SOC ......................................................... 3Figure 3-1 Updated Self-Service Application with Multi-lingual interface .............. 6
LIST OF TABLES
Table 3-1 COVID-19 Term Examples ................................................................... 4
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

What’s New MedDRA Version 25.1
September 2022
000799iii

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
25.0 and 25.1.
Section 2, Version 25.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 25.1, highlights changes in Version 25.1
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 25.1
September 2022
0007991

Version 25.1 Change Requests

2. VERSION 25.1 CHANGE REQUESTS
2.1

TERMINOLOGY CHANGES

Changes to MedDRA result from user change requests, from proactivity requestssubmitted 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 25.1 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 1,083 change requests processed for this version; 871 change requests wereapproved and implemented, and 210 change requests were not approved. There are, inaddition, 2 change request 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 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 MedDRA WebBased Browser via the “supplemental view” feature. Supplemental information 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 25.1 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 25.1 (shown in Table 4-5) and thecorresponding information for Version 25.0. Additionally, LLT currency status changes
are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA Version 25.1.

What’s New MedDRA Version 25.1
September 2022
0007992

Version 25.1 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

2293050

21265730103856
55
50
57

618
22
1729

79

16279

45
102

574

97

Figure 2-1 Net Changes of Terms per SOC

What’s New MedDRA Version 25.1
September 2022
0007993

New Developments in Version 25.1

3. NEW DEVELOPMENTS IN VERSION 25.1
3.1

ADDITIONAL COVID-19 RELATED TERMS

The MSSO continued to add COVID-19 related terms in MedDRA Version 25.1 based
upon MedDRA user requests. A total of 11 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
Confirmed
immunological vaccine
failurePT
Vaccination failure

HLT
Therapeutic andnontherapeutic
responses

Primary SOCGeneral disorders
and administrationsite conditionsInfections andinfestations
Surgical andmedicalprocedures

COVID-19 rebound

COVID-19Coronavirus
infections

Vaccination booster
doseImmunisation

Immunisations

Table 3-1 COVID-19 Term Examples

3.2

STANDARDISED MedDRA QUERIES (SMQs)

No new SMQs have been added for MedDRA Version 25.1. There were 202 approved
PT changes to existing SMQs. To view changes to existing SMQs, please review theMedDRA Version 25.1 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 25.1 change request processing period, there were no open orimplemented 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 25.1
September 2022
0007994

New Developments in Version 25.1

3.4

NEW MedDRA LANGUAGES DEPLOYED AND UNDER DEVELOPMENT

In 2020, the MedDRA Management Committee (MC) approved additional MedDRA
translations for the European Economic Area (EEA) official languages. This includes up
to a total of 17 additional European languages to support the electronic productinformation initiative. Note that this initiative includes the translation of MedDRA terms
only and does not include MedDRA user documentation.
The MSSO released Swedish and Latvian MedDRA in May 2022. Presently, Estonian,Finnish, Greek, Icelandic, Maltese, Norwegian, and Polish translations are indevelopment. The remaining languages in the EEA region will be translated and madeavailable between the years of 2023 to 2024. The MSSO will provide estimated release
dates for these languages as they become available.
Additionally, in July 2021 the MedDRA Management Committee approved an Arabic
MedDRA translation. This translation began development in 2022 and will include all
MedDRA user documentation. The MSSO expects to deploy the Arabic translation of
MedDRA before the end of 2022.

3.5

MedDRA SELF-SERVICE APPLICATION UPDATEIn April 2022, the MSSO deployed updates to the MedDRA Self-Service Application(SSA) to further facilitate the use of this tool for MedDRA users. The SSA provides
resources to users answers questions such as:•Who is my MedDRA subscription point of contact?

•

What is my MedDRA ID?

•

What is my MedDRA subscription password?

•Can you confirm the subscription status of my business partners?

•How do I get a training certificate for training classes?

What’s New MedDRA Version 25.1
September 2022
0007995

New Developments in Version 25.1

Figure 3-1 Updated Self-Service Application with Multi-lingual interface

The deployed updates include two key features.
•A refreshed user interface with a multi-lingual option for all supported MedDRAlanguages•

Training certificates are now offered for both virtual and face-to-face training
courses

These features improve the utility of the SSA and facilitate its use, particularly for nonEnglish speakers.

What’s New MedDRA Version 25.1
September 2022
0007996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 25.1. For detailed information on the changes to Version 25.1, please see theMedDRA Version Report in MVAT.
Number ofRecords inV25.0

Number ofRecords in
V25.1

Changehlgt.asc

337

337

0hlgt_hlt.asc

1,755

1,7550hlt.asc

1,737

1,7370hlt_pt.asc

37,186

37,468282llt.asc

85,091

85,668577

meddra_history_english.asc*

133,409134,220811

110mdhier.asc

39,352

39,647295pt.asc

25,412

25,592180

soc.asc27

270

soc_hlgt.asc

354

3540

intl_ord.asc

27

270

smq_list.asc

230

2300

smq_content.asc

92,22692,825599

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 25.1
September 2022
0007997Summary of Changes

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

Currency Status

v25.0

v25.1

LLTCurrent Terms

75,78776,364

LLT

Non-current Terms

9,304

9,304

LLT

Total LLTs1

85,091

85,668

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 Change

v25.0

v25.1

10110

110

2082

82

3020

20

4016

16

5022

Table 4-3 Summary of Impact on SMQs

4.2

SUMMARY OF IMPACT ON RECORDS IN MedDRA FILESThe 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 25.1. Please see the MedDRA Version Report inMVAT for details.
What’s New MedDRA Version 25.1
September 2022
0007998Summary of Changes

Number ofRecords in Table

File Name
hlgt.seq0

hlgt_hlt.seq

0hlt.seq0

hlt_pt.seq

384

llt.seq677

mdhier.seq

405

pt.seq234

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.

SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Blood andlymphatic systemdisorders

1,249

324

4,561

1,12387

17

Cardiac disorders

1,563

3842,588

688

36

10

What’s New MedDRA Version 25.1
September 2022
000799

HLTs3 HLGTs3

9

Summary of Changes
SOC

LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Congenital,familial andgenetic disorders

4,337

1,733

4,337

1,733

100

19

Ear and labyrinth
disorders

456

102

919

245

17

6

Endocrine
disorders

726

204

1,986

609

38

9

Eye disorders

2,670

674

4,096

1,152

63

13

Gastrointestinal
disorders

4,137

957

8,072

1,898

105

21

General disorders
andadministration site
conditions

2,550

1,020

3,553

1,389

35

7

Hepatobiliary
disorders

728

222

1,590

473

194

Immune systemdisorders

580

167

3,113

885

26

4

Infections andinfestations

7,672

2,146

8,097

2,272

150

12

Injury, poisoning
and procedural
complications

7,183

1,356

10,241

2,686

78

9

Investigations

14,707

6,156

14,707

6,156

106

23

Metabolism andnutrition disorders

1,037

307

3,017

880

63

14

What’s New MedDRA Version 25.1
September 2022
000799

HLTs3 HLGTs3

10

Summary of Changes
SOCLLTs(Primary)1

PTs(Primary)1

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

Musculoskeletaland connective
tissue disorders

2,790

518

7,130

1,492

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,950

2,073

9,821

2,421

201

39

Nervous systemdisorders

3,996

1,077

8,022

2,233

108

20

Pregnancy,
puerperium andperinatal
conditions

1,708

249

3,081

676

48

8

Product issues

912

180

942

194

21

2

Psychiatricdisorders

2,471

566

3,475

865

77

23

Renal and urinary
disorders

1,299

385

2,787

809

32

8

Reproductive
system andbreast disorders

1,8545314,538

1,298

52

16

Respiratory,
thoracic andmediastinal
disorders

1,905

595

4,634

1,292

49

12

Skin andsubcutaneous
tissue disorders

2,333

567

5,904

1,572

56

10

Socialcircumstances

670

289

670

289

20

7

What’s New MedDRA Version 25.1
September 2022
000799

HLTs3 HLGTs3

11

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2Surgical andmedicalprocedures

5,746

2,468

5,746

2,468

141

19

Vasculardisorders

1,439

342

7,375

1,849

68

11

Total

85,66825,592SOCHLTs3 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 HLTs
and HLGTs are greater than those found in Table 4-1.

4.4

LLT CURRENCY STATUS CHANGESNo currency changes occurred for MedDRA Version 25.1.

What’s New MedDRA Version 25.1
September 2022
00079912