C

What’s New
MedDRA Version 24.1

September 2021
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Acknowledgements

ACKNOWLEDGEMENTS
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What’s New MedDRA Version 24.1
September 2021
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Table of Contents

Table of Contents
1.

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

2.

VERSION 24.1 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2

3.

NEW DEVELOPMENTS IN VERSION 24.1 ........................................................... 4
3.1 ADDITIONAL COVID-19 RELATED TERMS .................................................... 4
3.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 4
3.3 PROACTIVITY REQUESTS ............................................................................. 5
3.4 MedDRA USER DOCUMENT STEAMLINING ................................................ 5
3.5 SNOMED CT – MedDRA MAPS ....................................................................... 7
3.6 NEW MedDRA LANGUAGES UNDER DEVLEOPMENT ................................. 84.

SUMMARY OF CHANGES ..................................................................................... 9
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ......................................... 9
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ......................... 10
4.3 MedDRA TERM COUNTS BY SOC ................................................................ 11
4.4 LLT CURRENCY STATUS CHANGES ........................................................... 14

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
Figure 3-1 MedDRA Introductory Guide Streamlined Document Example ........... 6
Figure 3-2 SNOMED CT – MedDRA Mapping example ....................................... 7
LIST OF TABLES
Table 3-1 COVID-19 Term Examples .................................................................. 4
Table 4-1 MedDRA Term File Counts ................................................................. 9
Table 4-2 Summary of Impact on LLTs ............................................................. 10
Table 4-3 Summary of Impact on SMQs ........................................................... 10
Table 4-4 Summary of Impact on Records in MedDRA Files ............................ 11
Table 4-5 MedDRA Term Counts by SOC......................................................... 14
Table 4-6 LLT Currency Changes ..................................................................... 15

What’s New MedDRA Version 24.1
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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
24.0 and 24.1.
Section 2, Version 24.1 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 24.1, highlights changes in Version 24.1
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 International AT&T Toll Free at 1-877-258-8280 or mssohelp@meddra.org.

What’s New MedDRA Version 24.1
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Version 24.1 Change Requests

2. VERSION 24.1 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 24.1 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 1,874 change requests processed for this version; 1,481 change requests wereapproved and implemented, and 392 change requests were not approved. There is, inaddition, 1 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 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-Based
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 24.1 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 24.1 (shown in Table 4-5) and thecorresponding information for Version 24.0. Additionally, LLT currency status changes
are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA Version 24.1.

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Version 24.1 Change Requests
Blood and lymphatic system disorders

37

Cardiac disorders
Congenital, familial and genetic disorders

18

Ear and labyrinth disorders
Endocrine disorders
Eye disorders

44
70

40

59

Gastrointestinal disorders

17

Hepatobiliary disorders
Immune system disorders

95

51

General disorders and administration site…

84

Infections and infestations
Injury, poisoning and procedural complications

92

142

171

Investigations

65

Metabolism and nutrition disorders
Musculoskeletal and connective tissue…
Nervous system disorders

22

Pregnancy, puerperium and perinatal…
Product issues
Psychiatric disorders

19

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

85

68

Neoplasms benign, malignant and…

7

119

37
37
38

59

75
104

160

Figure 2-1 Net Changes of Terms per SOC

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3

New Developments in Version 24.1

3. NEW DEVELOPMENTS IN VERSION 24.1
3.1

ADDITIONAL COVID-19 RELATED TERMS

The MSSO continued to add COVID-19 related terms in MedDRA Version 24.1 based
upon MedDRA user requests. A total of 19 new COVID-19 related LLTs/PTs wereadded including terms related to COVID-19 vaccines. See the table below for several
examples:
LLT
Anti-platelet factor 4
antibody positivePT
Anti-platelet factor 4
antibody positive

HLT
Coagulation andbleeding analyses

Primary SOC

Multisystem inflammatory
syndrome

Multisystem
inflammatory
syndrome

Immune andassociatedconditions NEC

Immune systemdisordersMultisystem inflammatory
syndrome in adults

Multisystem
inflammatory
syndrome in adults

Immune andassociatedconditions NEC

Immune systemdisorders

Thrombosis withthrombocytopenia
syndrome

Thrombosis withthrombocytopenia
syndrome

Thrombocytopenias

Blood and lymphatic
system disorders

Vaccination first dose

Immunisation

Immunisations

Surgical and medical
procedures

Vaccination second dose

Immunisation

Immunisations

Surgical and medical
procedures

Investigations

Table 3-1 COVID-19 Term Examples

3.2

STANDARDISED MedDRA QUERIES (SMQs)

One new SMQ has been added for MedDRA Version 24.1 - SMQ Sexual dysfunction.
There are now 109 level 1 SMQs in production as of this version. In addition, there were
315 approved PT changes to existing SMQs. To view changes to existing SMQs, please
review the MedDRA Version 24.1 Version Report.
Please see the MedDRA Version 24.1 SMQ Introductory Guide for detailed information
on new SMQ Sexual dysfunction.

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4

New Developments in Version 24.1

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 24.1 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 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

MedDRA USER DOCUMENT STEAMLINING

Beginning with MedDRA Version 24.1, the MedDRA user documents have beenstreamlined to make them more user-friendly. The specific documents affected are:•••

MedDRA Introductory Guide
SMQ Introductory Guide
Distribution File Format Document

The revisions retain essential information, but remove unnecessary details and term
citations. A summary of these changes include:•

Section 6 of the MedDRA Introductory Guide has been rewritten into a moreconcise and easy to read format•

Outdated information and unnecessary term citations were removed from theSMQ Introductory Guide•

The MedDRA file record counts in the Distribution File format document havebeen moved to the What’s New document to consolidate redundant information

See below for an example from the MedDRA Introductory Guide.

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5

New Developments in Version 24.1

Figure 3-1 MedDRA Introductory Guide Streamlined Document Example

These updates have been applied to all 14 supported languages.

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6

New Developments in Version 24.1

3.5

SNOMED CT – MedDRA MAPS

On 30 April 2021, ICH and SNOMED International announced the release of important
new maps between the global medical terminologies SNOMED CT and MedDRA. The
maps are intended to facilitate the exchange of data between regulatory databases(which use MedDRA) and healthcare databases/electronic health records (which use
SNOMED CT). There are two independent maps (MedDRA to SNOMED CT and
SNOMED CT to MedDRA) which were derived from frequently used and key
pharmacovigilance MedDRA terms. See the example below. MedDRA users may
obtain the maps via the download page of the MedDRA website. They will be released
annually every April.

Figure 3-2 SNOMED CT – MedDRA Maps example

To allow users to contribute to the maintenance of the maps, the MSSO deployed a free
online mapping change request tool called MapCR. MapCR allows licensed MedDRA
or SNOMED CT users to submit change requests for additions or changes to maps andto search for submitted requests. For more information about the SNOMED CT to
MedDRA maps and MapCR, please see the Mapping section of the MedDRA website.
In addition to the SNOMED CT to MedDRA maps, the MSSO is pursuing, with thesupport of the MedDRA Management Committee (MC), the development andmaintenance of an ICD-10 to MedDRA mapping. The MedDRA MC has also supported
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7

New Developments in Version 24.1

exploring with the World Health Organization (WHO) the development and maintenanceof mappings between ICD-11 and MedDRA. The MSSO will be releasing more details
about these mappings (e.g., timelines and formats) when they become available.

3.6

NEW MedDRA LANGUAGES UNDER DEVLEOPMENT

In 2020, the MedDRA 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 product information 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 quarter of 2022. The
remaining languages in the EEA region will be translated and made available between
the years of 2022 to 2024. The MSSO will provide estimated release dates for theremaining languages as they become available.
Additionally, in July 2021 the MedDRA Management Committee approved an Arabic
MedDRA translation. This translation is expected to begin development in 2022 and will
include all MedDRA user documentation. The MSSO will provide an estimated release
date for Arabic MedDRA once development of the translation is underway.

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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 24.1. For detailed information on the changes to Version 24.1, please see the
MedDRA Version Report in MVAT.
Number ofRecords in
V24.0

Number ofRecords inV24.1

Changehlgt.asc

337

337

0

hlgt_hlt.asc

1,755

1,755

0

hlt.asc

1,737

1,737

0

hlt_pt.asc

36,206

36,633427

llt.asc

83,291

84,139848

meddra_history_english.asc*

130,809

132,027

1,218

1

1

0

mdhier.asc

38,322

38,767445

pt.asc24,82025,077257

soc.asc27

27

0

soc_hlgt.asc

354

354

0

intl_ord.asc

27

27

0

smq_list.asc

228

229

1

smq_content.asc

89,20290,5971,395File Namemeddra_release.asc*

Table 4-1 MedDRA Term File Counts

MedDRA v24.1 is a simple change version which means changes are only made at the
PT and LLT levels of the MedDRA hierarchy; hence there are no changes in the number
of HLTs and HLGTs.
* 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.

The table below identifies the number of current vs. non-current terms.
What’s New MedDRA Version 24.1
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Summary of Changes

LLT Changes
Level

Currency Status

v24.0

v24.1

LLT

Current Terms

73,991

74,838

LLT

Non-current Terms

9,300

9,301*

LLT

Total LLTs1

83,291

84,139

Table 4-2 Summary of Impact on LLTs

1

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

*Note in MedDRA Version 24.1 seven LLTs changed currency status. Four LLTs
changed to a status of non-current and three LLTs changed to a status of current for a
net change of one for the non-current term count of 9,301. See table 4-6 for an
explanation of currency changes.
New SMQs
Level Net Change

v24.0

v24.1

1

1

108

109

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 24.1. Please see the MedDRA Version Report in
MVAT for details.
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Summary of Changes

Number ofRecords in Table

File Name
hlgt.seq0

hlgt_hlt.seq

0hlt.seq0

hlt_pt.seq

605

llt.seq

1,075

mdhier.seq

639

pt.seq364

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

1,223

313

4,498

1,099

87

17

Cardiac disorders

1,530

375

2,524

669

36

10

Congenital,familial andgenetic disorders

4,223

1,677

4,223

1,677

100

19

What’s New MedDRA Version 24.1
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HLTs3 HLGTs3

11

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Ear and labyrinth
disorders

451

99

904

239

17

6

Endocrine
disorders

707

201

1,935

592

38

9

Eye disorders

2,637

663

4,034

1,130

63

13

Gastrointestinal
disorders

4,079

943

7,955

1,867

105

21

General disordersandadministration site
conditions

2,515

1,012

3,484

1,368

35

7

Hepatobiliary
disorders

713

218

1,569

465

19

4

Immune systemdisorders

559

161

3,009

852

26

4

Infections andinfestations

7,566

2,105

7,978

2,225

150

12

Injury, poisoning
and procedural
complications

7,070

1,318

10,021

2,612

78

9

Investigations

14,473

6,052

14,473

6,052

106

23

Metabolism andnutrition disorders

1,027

304

2,940

854

63

14

Musculoskeletaland connective
tissue disorders

2,748

510

7,019

1,458

59

11

What’s New MedDRA Version 24.1
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HLTs3 HLGTs3

12

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

8,837

2,042

9,682

2,380

201

39

Nervous systemdisorders

3,879

1,039

7,823

2,164

108

20

Pregnancy,
puerperium andperinatalconditions

1,682

240

3,026

655

48

8

Product issues

902

178

933

192

21

2

Psychiatricdisorders

2,451

563

3,426

856

77

23

Renal and urinary
disorders

1,286

380

2,753

799

32

8

Reproductive
system andbreast disorders

1,831

518

4,466

1,262

52

16

Respiratory,
thoracic andmediastinal
disorders

1,869

581

4,552

1,258

49

12

Skin andsubcutaneous
tissue disorders

2,256

550

5,727

1,528

56

10

Socialcircumstances

659

283

659

283

20

7

Surgical andmedicalprocedures

5,543

2,416

5,543

2,416

141

19

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HLTs3 HLGTs3

13

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Vasculardisorders

1,423

336

7,257

1,815

Total

84,13925,077

SOC

HLTs3 HLGTs3

68

11

Table 4-5 MedDRA Term Counts by SOC

Primary 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.
1

Total 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.
2

The HLT and HLGT counts are not necessarily unique values given MedDRA’s multiaxiality (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.
3

4.4

LLT CURRENCY STATUS CHANGESThe following table reflects seven terms at the LLT level in MedDRA Version 24.1 that
had a change in currency status along with the rationale for the change.

Lowest Level Term

Ear, nose and throat
infection

Currency
StatusChanged to

Rationale

Current

Ear, nose and throat infection is a valid medical concept
and is frequently reported as an indication as well as anadverse event. Note that in MedDRA Version 24.1, LLT
Ear, nose and throat infection was promoted from under
PT Upper respiratory tract infection to the PT level, toallow appropriate linkage to primary HLT Infections
NEC and secondary HLTs - HLT Ear disorders NEC
and HLT Upper respiratory tract infections NEC.

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Summary of Changes
Lowest Level Term

Hurler's disease

MGUS undetermined

Currency
StatusChanged to

Rationale

Current

LLT Hurler's disease is a valid synonym of existing PT
Mucopolysaccharidosis. Therefore, the term waschanged to a status of current.

Current

LLT MGUS undetermined was changed to a status of
current because it is a valid acronym of Monoclonal
gammopathy of undetermined significance.
Following a demotion under existing PT Airway patency
device insertion, LLT Airway patency oesophageal
device was changed to a status of non-current as it
does not include the word "insertion" to distinguish it asa procedure from the device itself. This procedural
concept is already represented by LLT
Pharyngotracheal lumen airway insertion.
LLT Airway patency esophageal device was changed toa status of non-current, as it does not include the word
"insertion" to distinguish it as a procedure from thedevice itself. This procedural concept is alreadyrepresented by LLT Pharyngotracheal lumen airway
insertion.

Airway patency oesophageal
deviceNon-Current

Airway patency esophageal
deviceNon-Current

Hydropic decompensation

Non-current

The currency status of LLT Hydropic decompensation
was changed to non-current as it is an ambiguous termthat could refer to cardiac or hepatic decompensation.

Myocardial strain

Non-Current

PT Myocardial strain was demoted to an LLT under the
new PT Myocardial strain imaging and it status waschanged to non-current because of its ambiguity.

Table 4-6 LLT Currency Changes

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