C

What’s New
MedDRA Version 25.0

March 2022
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Acknowledgements

ACKNOWLEDGEMENTS
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What’s New MedDRA Version 25.0
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Table of Contents

Table of Contents
1.

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

2.

VERSION 25.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 33.

NEW DEVELOPMENTS IN VERSION 25.0 ........................................................... 6
3.1 ADDITIONAL COVID-19 RELATED TERMS .................................................... 6
3.2 STANDARDISED MedDRA QUERIES (SMQs) ................................................ 6
3.3 PROACTIVITY REQUESTS ............................................................................. 7
3.4 SNOMED CT – MedDRA MAPPING UPDATE ................................................. 7
3.5 NEW MedDRA LANGUAGES UNDER DEVELOPMENT ................................. 94.

SUMMARY OF CHANGES ................................................................................... 10
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ....................................... 10
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ......................... 11
4.3 MedDRA TERM COUNTS BY SOC................................................................ 12
4.4 LLT CURRENCY STATUS CHANGES ........................................................... 15

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
Figure 3-1 MapCR Change Request Tool ............................................................ 8
Figure 3-2 SNOMED CT – MedDRA Package and Supplemental Release ......... 8
LIST OF TABLES
Table 2-1 New HLGTs ......................................................................................... 4
Table 2-2 Merged HLGTs .................................................................................... 4
Table 2-3 New HLTs ........................................................................................... 4
Table 2-4 Merged HLTs....................................................................................... 5
Table 3-1 COVID-19 Term Examples .................................................................. 6
Table 4-1 MedDRA Term File Counts ............................................................... 10
Table 4-2 Summary of Impact on LLTs ............................................................. 11
Table 4-3 Summary of Impact on SMQs ........................................................... 11
Table 4-4 Summary of Impact on Records in MedDRA Files ............................ 12
Table 4-5 MedDRA Term Counts by SOC......................................................... 15
Table 4-6 LLT Currency Changes ..................................................................... 16

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

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Version 25.0 Change Requests

2. VERSION 25.0 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 25.0 is a complex change version which means changes may madeat any level of the MedDRA hierarchy.
Change requests involve both MedDRA updates and SMQ changes. There was a totalof 1,832 change requests processed for this version; 1,508 change requests wereapproved and implemented, and 299 change requests were not approved. There are, in
addition, 25 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 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 25.0 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 25.0 (shown in Table 4-5) and thecorresponding information for Version 24.1. Additionally, LLT currency status changes
are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA Version 25.0.

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Version 25.0 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

57
60
119
12
45
58
89
60
19
97
109
212
175
47
95
122
190
58
5
36
27
63
86
119
11

157
78

Figure 2-1 Net Changes of Terms per SOC

2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 25.0 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 29 July 2021 to 24 September 2021. Complex changes
were followed by further internal review and consensus discussions which resulted in
the final approved set of 8 complex changes.
The complex changes implemented in Version 25.0 are summarized below. Please see
the “Related Documents” on the Change Request section of the MedDRA website for
specific details.
At the SOC level: No changes were made to existing SOCs.

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Version 25.0 Change Requests

At the HLGT level: There were two High Level Group Terms (HLGTs) added and two
HLGTs merged as a result of complex changes in Version 25.0. The changes are as
follows:

New HLGT

To SOC

Cytogenetic investigations and genetic
analyses

Investigations

Skin and subcutaneous tissue infections
and infestations NEC

Skin and subcutaneous tissue disorders

Table 2-1 New HLGTs

Merged HLGTs
HLGT

To HLGT

Cytogenetic investigations
Skin and subcutaneous tissue
infections and infestations

Cytogenetic investigations
and genetic analyses
Skin and subcutaneous tissue
infections and infestations
NEC

SOC
Investigations
Skin and subcutaneous
tissue disorders

Table 2-2 Merged 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 25.0. The changes are as follows:
New HLTs
New HLTTo SOC

Hepatobiliary function diagnostic
procedures

Investigations

Skin histopathology and skin investigations
NEC

Investigations

Table 2-3 New HLTs

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Version 25.0 Change Requests

Merged HLTs
HLT

To HLT

SOC

Liver function analyses

Hepatobiliary function
diagnostic procedures

Investigations

Skin histopathology
procedures

Skin histopathology and skin
investigations NEC

Investigations

Table 2-4 Merged HLTs

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5

New Developments in Version 25.0

3. NEW DEVELOPMENTS IN VERSION 25.0
3.1

ADDITIONAL COVID-19 RELATED TERMS

The MSSO continued to add COVID-19 related terms in MedDRA Version 25.0 based
upon MedDRA user requests. A total of 54 new COVID-19 related LLTs/PTs wereadded including terms related to vaccines which may be applicable in the context of
COVID-19. See the table below for several examples:
LLT
SARS-CoV-2 infection
post vaccine

PT
Breakthrough
COVID-19

HLT
Coronavirus
infections

Primary SOC
Infections andinfestations

SARS-CoV-2 Omicron
variant infection

COVID-19

Coronavirus
infections

Infections andinfestations

Vaccine preparation
error

Product
preparation error

Product
preparation errors
and issues

Injury, poisoning
and procedural
complications

Vaccination hesitancy

Refusal of
vaccination

Social issues NEC

Socialcircumstances

Heterologous primeboost vaccination

Immunisation

Immunisations

Surgical andmedicalprocedures

Table 3-1 COVID-19 Term Examples

3.2

STANDARDISED MedDRA QUERIES (SMQs)

One new SMQs has been added for MedDRA Version 25.0 - SMQ Noninfectious
myocarditis/pericarditis. The focus of this SMQ is to identify cases of noninfectious
myocarditis and/or pericarditis possibly related to exposure to drugs, vaccines, andbiologics. It has relevance for cardiac adverse events following immunization (AEFIs)
with mRNA COVID-19 vaccines. There are now 110 level 1 SMQs in production as ofthis version. In addition, there were 309 approved PT changes to existing SMQs. Toview changes to existing SMQs, please review the MedDRA Version 25.0 Version
Report.

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New Developments in Version 25.0

Please see the MedDRA Version 25.0 SMQ Introductory Guide for detailed information
on new SMQ Noninfectious myocarditis/pericarditis.

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 25.0 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.

3.4

SNOMED CT – MedDRA MAPPING UPDATE

On 30 April 2021, ICH and SNOMED International announced the first production
release of important new maps between SNOMED CT and MedDRA. This collaborative
agreement between SNOMED International and ICH has produced two independent
maps (MedDRA to SNOMED CT and SNOMED CT to MedDRA) which are intended tofacilitate the exchange of data between regulatory databases and healthcare
databases/electronic health records.
Licensed users of either MedDRA or SNOMED CT can obtain the maps free of charge
from either the MSSO or SNOMED International. Users can also contribute to theongoing maintenance of the maps by submitting requests for new mappings or changes
to existing mappings by using a mapping change request submission tool, MapCR, on
the MedDRA website (https://mapcr.meddra.org).

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7

New Developments in Version 25.0

Figure 3-1 MapCR Change Request Tool

Since the first production release in April 2021, approximately 250 requests for new
term mappings have been received and will be implemented in the next production
release in April 2022. A preview set of these supplemental mappings for the upcoming
production release is available on the Downloads page of the MedDRA website.

Figure 3-2 SNOMED CT – MedDRA Package and Supplemental Release

The April 2022 production release will be based on MedDRA Version 24.1 (September2021) and the January 2022 release of SNOMED CT International Edition. In addition,
the updated release will include relevant COVID-19 terms and changes resulting fromversion updates of the two terminologies.

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8

New Developments in Version 25.0

3.5

NEW MedDRA LANGUAGES 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.
Presently, Greek, Latvian, Maltese, Polish, and Swedish translations are indevelopment and are expected to be completed in the first half of 2022. The MSSO will
begin development of four new European languages in 2022 – Estonian, Finnish,
Icelandic, and Norwegian. The remaining languages in the EEA region will be translated
and made available 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 Arabic MedDRA before theend of 2022.

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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 25.0. For detailed information on the changes to Version 25.0, please see the
MedDRA Version Report in MVAT.
Number ofRecords in
V24.1

Number ofRecords in
V25.0

Changehlgt.asc

337

337

0

hlgt_hlt.asc

1,755

1,755

0

hlt.asc

1,737

1,737

0

hlt_pt.asc

36,63337,186553

llt.asc

84,13985,091952

meddra_history_english.asc*

132,027

133,409

1,382

1

1

0

mdhier.asc

38,76739,352585

pt.asc25,07725,412335

soc.asc27

27

0

soc_hlgt.asc

354

354

0

intl_ord.asc

27

27

0

smq_list.asc

229

230

1

smq_content.asc

90,597

92,226

1,629

File Namemeddra_release.asc*

Table 4-1 MedDRA Term File Counts

MedDRA Version 25.0 is a complex change version which means changes may bemade at any level of the MedDRA hierarchy. In this case, there were two additions andtwo merges of HLGTs and HLTs. See section 2.2 Complex Changes above. As a result,the net number of changes to the HLT and HLGT record counts remain the same as last
release.
* The meddra_history_english.asc and meddra_release.asc files are optional files foruse with the MedDRA Desktop Browser (MDB) release 3.0.2 Beta and up. These files
are not part of the MedDRA schema.

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Summary of Changes

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

Currency Status

v24.1

v25.0

LLT

Current Terms

74,83875,787

LLT

Non-current Terms

9,301

9,304

LLT

Total LLTs1

84,13985,091

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

v24.1

v25.0

1

1

109

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

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 25.0. Please see the MedDRA Version Report in
MVAT for details.

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Summary of Changes

File Name

Number ofRecords in Table

hlgt.seq

4

hlgt_hlt.seq

20

hlt.seq4

hlt_pt.seq

985

llt.seq

1,209

mdhier.seq

1,749

pt.seq421

soc.seq0

soc_hlgt.seq

4

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.
LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

HLTs3 HLGTs3

Blood andlymphatic systemdisorders

1,241

318

4,543

1,113

87

17

Cardiac disorders

1,553

381

2,571

683

36

10

Congenital,familial andgenetic disorders

4,304

1,716

4,304

1,716

100

19

SOC

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Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Ear and labyrinth
disorders

453

100

914

242

17

6

Endocrine
disorders

719

202

1,971

603

38

9

Eye disorders

2,655

669

4,076

1,146

63

13

Gastrointestinal
disorders

4,105

950

8,025

1,888

105

21

General disordersandadministration site
conditions

2,534

1,017

3,530

1,381

35

7

Hepatobiliary
disorders

722

221

1,582

471

19

4

Immune systemdisorders

576

165

3,086

871

26

4

Infections andinfestations

7,633

2,133

8,055

2,258

150

12

Injury, poisoning
and procedural
complications

7,156

1,345

10,183

2,664

78

9

Investigations

14,5906,111

14,590

6,111

106

23

Metabolism andnutrition disorders

1,032

306

2,969

873

63

14

Musculoskeletaland connective
tissue disorders

2,771

518

7,090

1,482

59

11

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HLTs3 HLGTs3

13

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

8,916

2,067

9,774

2,411

201

39

Nervous systemdisorders

3,969

1,065

7,964

2,212

108

20

Pregnancy,
puerperium andperinatalconditions

1,706

248

3,068

671

48

8

Product issues

907

179

937

193

21

2

Psychiatricdisorders

2,467

566

3,454

864

77

23

Renal and urinary
disorders

1,292

384

2,773

806

32

8

Reproductive
system andbreast disorders

1,837

527

4,502

1,289

52

16

Respiratory,
thoracic andmediastinal
disorders

1,894

591

4,612

1,285

49

12

Skin andsubcutaneous
tissue disorders

2,293

560

5,821

1,552

56

10

Socialcircumstances

667

287

667

287

20

7

Surgical andmedicalprocedures

5,670

2,446

5,670

2,446

141

19

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HLTs3 HLGTs3

14

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Vasculardisorders

1,429

340

7,316

1,834

Total

85,091

25,412SOC

HLTs3 HLGTs3

68

11

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.

4.4

LLT CURRENCY STATUS CHANGESThe following table reflects three terms at the LLT level in MedDRA Version 25.0 that
had a change in currency status along with the rationale for the change.

Lowest Level Term

Hypoglossal nerve stimulator

Infusion related hypotension

Currency
StatusChanged to

Rationale

Non-current

LLT Hypoglossal nerve stimulator (under PT
Hypoglossal nerve stimulation) was changed to a status
of non-current because the concept represents thename of a device which is out of scope of MedDRA.

Non-current

LLT Infusion related hypotension (under PT Infusion
related reaction) was changed to a status of non-current
because the concept represents a combination of
infusion related reaction and a systemic event.

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Summary of Changes

Lowest Level Term

Red manCurrency
StatusChanged to

Rationale

Non-current

Vancomycin infusion reaction, a new PT added in
Version 25.0, is now the currently accepted
nomenclature for this specific drug reaction and isintended to provide an alternative term for the concept
of “Red Man Syndrome” which carries racist
connotations and implies a white male reference.

Table 4-6 LLT Currency Changes

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