C

What’s New
MedDRA Version 24.0

March 2021
000550Acknowledgements

ACKNOWLEDGEMENTS
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What’s New MedDRA Version 24.0
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Table of Contents

TABLE OF CONTENTS
1.

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

2.

VERSION 24.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 33.

NEW DEVELOPMENTS IN VERSION 24.0 ........................................................... 5
3.1 NEW COVID-19 TERMS AND REVIEW OF VACCINE RELATED TERMS ..... 5
3.2 STANDARDISED MedDRA QUERIES (SMQS) ............................................... 6
3.3 PROACTIVITY REQUESTS ............................................................................. 6
3.4 MedDRA APPLICATION PROGRAM INTERFACES IN BETA RELEASE ...... 64.

SUMMARY OF CHANGES ..................................................................................... 8
4.1 SUMMARY OF IMPACT ON THE TERMINOLOGY ......................................... 8
4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES ......................... 10
4.3 MedDRA TERM COUNTS .............................................................................. 11
4.4 MODIFIED PT AND LLT NAMES ................................................................... 14
4.5 LLT CURRENCY STATUS CHANGES ........................................................... 14

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 New COVID-19 Term Examples.......................................................... 5
Table 3-2 Vaccine Related Term Examples ........................................................ 6
Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs ...................................... 8
Table 4-2 Summary of Impact on PTs ................................................................. 9
Table 4-3 Summary of Impact on LLTs ............................................................... 9
Table 4-4 Summary of Impact on SMQs ........................................................... 10
Table 4-5 Summary of Impact on Records in MedDRA Files ............................ 11
Table 4-6 MedDRA Term Counts ...................................................................... 14
Table 4-7 LLT Currency Changes ..................................................................... 15

What’s New MedDRA Version 24.0
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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
23.1 and 24.0.
Section 2, Version 24.0 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 24.0, highlights changes in Version 24.0
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



Modified Lowest Level Terms (LLT) and Preferred Term (PT) names



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 24.0
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Version 24.0 Change Requests

2. VERSION 24.0 CHANGE REQUESTS
2.1

TEMINOLOGY 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 24.0 is a complex change version which means that changes may bemade above PT level.
Change requests involve both MedDRA updates and SMQ changes. There was a totalof 1,446 change requests processed for this version; 1,165 change requests wereapproved and implemented, and 274 change requests were not approved. There are, in
addition, 7 change requests 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 identical 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 24.0 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 24.0 (shown in Table 4-6) and thecorresponding information for Version 23.1. Additionally, term name changes and LLTcurrency status changes are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA Version 24.0.

What’s New MedDRA Version 24.0
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Version 24.0 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

62
15
48
11
12
52
81
33
9
78
95
122

155
34
60
85
82

10
23
33
37
33
81
48
6
153
88

Figure 2-1 Net Changes of Terms per SOC

2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 24.0 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 31 July 2020 to 25 September 2020. Complex changes
were followed by further internal review and consensus discussions which resulted in
the final approved set of 7 complex changes.
The complex changes implemented in Version 24.0 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 24.0 Change Requests

At the HLGT level: No changes were made to existing HLGTs.
At the HLT level: There were three High Level Terms (HLTs) added and four merged
as a result of complex changes in Version 24.0. The changes are as follows:
New HLTs
New HLTTo SOC

Auditory and vestibular diagnostic
procedures

Investigations

Follicular lymphomas

Multi-axial to Blood and lymphatic systemdisorders and Neoplasms benign,malignant and unspecified (incl cysts andpolyps)Hepatitis virus infections

Infections and infestations
Table 2-1 New HLTs

Merged HLTs
HLT
Auditory function diagnostic
procedures

To HLT
Auditory and vestibular
diagnostic procedures

Follicle centre lymphomas
diffuse predominantly small
cell

Follicular lymphomas

Follicle centre lymphomas,
follicular grade I, II, III

Follicular lymphomas

Hepatitis viral infections

Hepatitis virus infections

SOC
Investigations
Multi-axial to Blood andlymphatic system disorders
and Neoplasms benign,malignant and unspecified(incl cysts and polyps)
Multi-axial to Blood andlymphatic system disorders
and Neoplasms benign,malignant and unspecified(incl cysts and polyps)
Infections and infestations

Table 2-2 Merged HLTs

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New Developments in Version 24.0

3. NEW DEVELOPMENTS IN VERSION 24.0
3.1

NEW COVID-19 TERMS AND REVIEW OF VACCINE RELATED TERMS

The MSSO continued to add new COVID-19 terms to MedDRA Version 24.0 based onusers’ requests. A spreadsheet of COVID-19 terms added to MedDRA can be found on
the COVID-19 section of the MedDRA website. See the table below for several
examples:
LLT

PT

HLT

Primary SOC

Congenital SARS-CoV-2
infection

Congenital COVID-19

Viral infections
congenital

Congenital, familial
and genetic
disordersLaboratory confirmed
SARS-CoV-2 infection
without symptoms

Asymptomatic
COVID-19

Coronavirus
infections

Infections andinfestations

Long COVID

Post-acute COVID-19
syndrome

Coronavirus
infections

Infections andinfestations

COVID-19 screening

COVID-19 screening

Virus identificationand serology

Investigations

Table 3-1 New COVID-19 Term Examples

With the rollout of SARS-CoV-2 vaccines, there is a global focus on monitoring theeffectiveness and safety of these vaccines. In anticipation of this, the MSSO proactively
reviewed the vaccine-related terms in MedDRA and solicited feedback from aninternational group of regulatory and industry users on the MSSO’s proposals for new
terms for Version 24.0, as well as any other potential terms for additions. As a result of
this review, 15 new terms and changes were implemented in Version 24.0. See thetable below for several examples which include certain Adverse Events Following
Immunisation (AEFI) relevant for SARS-CoV-2 vaccines:PT

HLT

Primary SOC

Vaccine associatedenhanced disease

Immune and associatedconditions NEC

Immune system disorders

Vaccine derived SARSCoV-2 infection

Coronavirus infections

Infections and infestations

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New Developments in Version 24.0
PT

HLT

Primary SOC

SARS-CoV-2 RNA
increased

Virus identification andserology

Investigations

Acute aseptic arthritis

Arthropathies NEC

Musculoskeletal andconnective tissue disorders

Bell’s palsy (promoted fromPT Facial paralysis)

Facial cranial nerve
disorders

Nervous system disorders

Table 3-2 Vaccine Related Term Examples

3.2

STANDARDISED MedDRA QUERIES (SMQs)

No new SMQs were added for MedDRA Version 24.0. There were 302 approved PTchanges to existing SMQs. To view changes to existing SMQs, please review the
MedDRA Version 24.0 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 24.0 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

MedDRA APPLICATION PROGRAM INTERFACES IN BETA RELEASEAs of January 2021, the MedDRA Application Program Interfaces (APIs) are now
available to MedDRA users in a Beta release phase. The MSSO will begin work on
extending and formalizing API information to align with “Good practice” (GxP) quality
guidelines and regulations. Once this work is complete and the necessary information isavailable to users, the APIs will be in production.
In the meantime, MedDRA users are welcome to continue to review and make plans forusing the MedDRA APIs. The APIs are deployed onto a high availability cloudenvironment and no planned future modifications to API inputs or outputs will be madefrom this point forward to disrupt MedDRA user review and evaluation.

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New Developments in Version 24.0

The MedDRA APIs provide similar features and functions to the Web-Based Browser
and the MedDRA Version Analysis tool. For specific details on the APIs, please see“related documents” section of API page on the MedDRA website. Included on the API
page are a programmer’s guide, input examples and answers to frequently asked
questions.

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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 24.0. These tables are intended only as a reference. For detailed information on
the changes to Version 24.0, please see the MedDRA Version Report included within
the MedDRA download or in MVAT.
SOC, HLGT, HLT Changes
Level

Change Request Action Net Change v23.1 v24.0

SOC

Total SOCs

0

27

27

New HLGTs000

Merged HLGTs

0

0

0

Total HLGTs1

0

337

337

New HLTs303

Merged HLTs

4

0

4

Total HLTs1

-1

1,738

1,737

HLGT

HLT

Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs

1 Total net change of HLGTs or HLTs equals the number of new HLGTs or HLTs minus

the number of respective merged HLGTs or HLTs.

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Summary of Changes

PT Changes
Level Change Request Action

PT

v23.1

v24.0

New PTs

274

262

Promoted LLTs

15

23

Demoted PTs

31

36

Net Change1

258

249

Total PTs

24,571

24,820

Table 4-2 Summary of Impact on PTs
1Net change of PTs equals the number of new PTs plus the number of promoted LLTs

minus the number of demoted PTs.
LLT Changes
Level

Currency Status

Net Change

v23.1

v24.0

LLT

Current Terms

707

73,28473,991

LLT

Non-current Terms

1

9,299

9,300

LLT

Total LLTs1

708

82,583

83,291

Table 4-3 Summary of Impact on LLTs

1Total LLTs include PTs as they are also in the LLT distribution file.

New SMQs
Level Net Change

v23.1

v24.0

1

0

108

108

2

0

82

82

3

0

20

20

What’s New MedDRA Version 24.0
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Summary of Changes

Level Net Change

v23.1

v24.0

4

0

16

16

5

0

2

2

Table 4-4 Summary of Impact on SMQs

4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES
The table below summarizes the impact on MedDRA in Version 24.0. The table isintended only as a reference.

INTL_ORD.ASC

SOC.ASC

SOC_HLGT.ASC

HLGT.ASCHLGT_HLT.ASC

HLT.ASC

HLT_PT.ASC

MDHIER.ASC

What’s New MedDRA Version 24.0
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0Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

0

Removed0Modified

0

Added

3

Removed4

Modified

0

Added

3

Removed4

Modified

0

Added

538

Removed

153

Modified

0

Added

586

Removed183

Modified010Summary of Changes

PT.ASC

LLT.ASC

SMQ_LIST.ASC1

SMQ_CONTENT.ASC

Added

285

Removed36

Modified

9

Added

708

Removed0Modified

175

Added10Removed0Modified

228

Added

874

Removed0Modified

222

Table 4-5 Summary of Impact on Records in MedDRA Files

1 The number of SMQs added includes both top level (Level 1) and sub-search SMQs.

4.3

MedDRA TERM COUNTS

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

Blood andlymphatic systemdisorders

1,211

309

4,468

1,087

87

17

Cardiac disorders

1,510

367

2,499

658

36

10

Congenital,familial andgenetic disorders

4,173

1,658

4,173

1,658

100

19

Ear and labyrinth
disorders

447

96

893

233

17

6

SOC

What’s New MedDRA Version 24.0
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HLTs3 HLGTs3

11

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Endocrine
disorders

698

198

1,907

581

38

9

Eye disorders

2,595

655

3,985

1,120

63

13

Gastrointestinal
disorders

4,045

931

7,889

1,839

105

21

General disordersandadministration site
conditions

2,495

1,008

3,447

1,354

35

7

Hepatobiliary
disorders

704

217

1,556

461

19

4

Immune systemdisorders

544

157

2,950

828

26

4

Infections andinfestations

7,512

2,079

7,915

2,197

150

12

Injury, poisoning
and procedural
complications

7,023

1,302

9,921

2,572

78

9

Investigations

14,352

6,002

14,352

6,002

106

23

Metabolism andnutrition disorders

1,006

295

2,892

838

63

14

Musculoskeletaland connective
tissue disorders

2,703

497

6,951

1,441

59

11

Neoplasms
benign, malignant
and unspecified

8,796

2,032

9,627

2,368

201

39

SOC

What’s New MedDRA Version 24.0
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HLTs3 HLGTs3

12

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Nervous systemdisorders

3,839

1,032

7,728

2,140

108

20

Pregnancy,
puerperium andperinatalconditions

1,678

239

3,008

651

48

8

Product issues

870

173

901

187

21

2

Psychiatricdisorders

2,434

560

3,394

851

77

23

Renal and urinary
disorders

1,281

379

2,738

795

32

8

Reproductive
system andbreast disorders

1,819

515

4,436

1,254

52

16

Respiratory,
thoracic andmediastinal
disorders

1,846

577

4,506

1,246

49

12

Skin andsubcutaneous
tissue disorders

2,229

540

5,674

1,506

56

10

Socialcircumstances

656

280

656

280

20

7

Surgical andmedicalprocedures

5,412

2,389

5,412

2,389

141

19

Vasculardisorders

1,413

333

7,182

1,786

68

11

SOC

HLTs3 HLGTs3(incl cysts andpolyps)What’s New MedDRA Version 24.0
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Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

Total

83,291

24,820

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

HLTs3 HLGTs3

Table 4-6 MedDRA Term Counts
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 4-2 and 4-3.
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 4-2 and 4-3.
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

MODIFIED PT AND LLT NAMESAs part of ongoing MedDRA maintenance activities, existing PTs and LLTs can be
modified (renamed) to correct for misspelling, double spacing, capitalization, or othererrors that meet the renaming criteria in MedDRA. This rename provision retains theoriginal MedDRA code of the term and preserves its original meaning. There were noterm name changes made for English MedDRA Version 24.0.

4.5

LLT CURRENCY STATUS CHANGESThe following table reflects one term at the LLT level in MedDRA Version 24.0 that hada change in currency status along with the rationale for the change.

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Summary of Changes

Lowest Level Term

Platelet aggregation NOS

Currency
StatusChanged to

Rationale

Non-current

PT Platelet aggregation was demoted to an LLT under
new PT Platelet aggregation test and made non-current
in Version 23.1 because the term is ambiguous andcould refer either to a test or an abnormality. LLT
Platelet aggregation NOS is also ambiguous and will bemade non-current based the same rationale.

Table 4-7 LLT Currency Changes

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