C

What’s New
MedDRA Version 27.0

March 2024
001030Acknowledgements

ACKNOWLEDGEMENTS
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What’s New MedDRA Version 27.0
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Table of Contents

TABLE OF CONTENTS
1.

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

2.

VERSION 27.0 CHANGE REQUESTS ................................................................... 2
2.1 TERMINOLOGY CHANGES ............................................................................. 2
2.2 COMPLEX CHANGES ...................................................................................... 33.

NEW DEVELOPMENTS IN VERSION 27.0 ........................................................... 5
3.1 STANDARDISED MedDRA QUERIES (SMQs) ................................................ 5
3.2 PROACTIVITY REQUESTS ............................................................................. 5
3.2.1
Primary SOC placement of PTs under HLT Oncologic complications
and emergencies................................................................................. 5
3.3 NEW MedDRA LANGUAGES DEPLOYED AND UNDER DEVELOPMENT .... 6
3.4 UPDATE TO APOSTROPHE IN MAINTAINED LANGUAGES ......................... 6
3.5 UPDATED WebCR ........................................................................................... 74.

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 ........................................................... 15

LIST OF FIGURES
Figure 2-1 Net Changes of Terms per SOC ......................................................... 3
Figure 3-1 New LLT request in the updated WebCR application.......................... 8
LIST OF TABLES
Table 2-1 New HLT .............................................................................................. 4
Table 2-2 Renamed HLT ...................................................................................... 4
Table 3-1 Primary SOC change of PTs under HLT Oncologic complications andemergencies .................................................................................................. 6
Table 3-2 Examples of Updated Translated Terms .............................................. 7
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 ...................................................................... 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
26.1 and 27.0.
Section 2, Version 27.0 Change Requests, provides a summary of information on thenumber of change requests processed for the version.
Section 3, New Developments in Version 27.0, highlights changes in Version 27.0
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 27.0
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Version 27.0 Change Requests

2. VERSION 27.0 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 27.0 is a complex change version which means changes may bemade at any level of the MedDRA hierarchy.
Change requests involve both MedDRA updates and SMQ changes. There was a totalof 1,582 change requests processed for this version; 1,206 change requests wereapproved and implemented, and 310 change requests were not approved. There are, in
addition, 66 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 which compares
MedDRA Version 26.1 to Version 27.0 is identical to the Version Report provided in the
MedDRA zip file download. MVAT is provided free of charge to MedDRA users as partof their subscription.
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 27.0 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 measure 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 27.0 (shown in Table 4-5) and thecorresponding information for Version 26.1. Additionally, LLT currency status changes
are included in Figure 2-1.
Please see Section 4 for a summary of the changes in MedDRA Version 27.0.

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Version 27.0 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

47

22

109

18
32
11

50

28

61
57

76

58

18
17
15

8

74
79

138

196

106

67
44
40

64
58

118

Figure 2-1 Net Changes of Terms per SOC

2.2

COMPLEX CHANGESThe proposals for complex changes considered during Version 27.0 included thosesubmitted by users 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 2023 to 22 September 2023. Complex
changes were followed by further internal review and consensus discussions which
resulted in the final approved set of 2 complex changes.
The complex changes implemented in Version 27.0 are summarized below. Please see
the “Related Documents” on the Change Request section of the MedDRA website for
specific details.
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Version 27.0 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 was one High Level Term (HLT) added and an existing HLTrenamed as a result of complex changes in Version 27.0.
The changes are as follows:
New HLTs
New HLTTo SOC
General disorders and administration site
conditions

Instillation site reactions1

Injury, poisoning and procedural
complications
Table 2-1 New HLT

Renamed HLTs
Old HLT Name
Application and instillationsite reactions

New HLT Name

Application site reactions1

To SOC
General disorders andadministration site conditions
Injury, poisoning andprocedural complications

Table 2-2 Renamed HLT

HLT Application and instillation site reactions was split into two separate HLTs – HLT
Application site reactions and HLT Instillation site reactions to improve analysis andassist with the differentiation between products which are applied, such as ointments,from those being instilled, such as eye drops. HLT Application and instillation site
reactions (code 10003057) was renamed to HLT Application site reactions which was
the original name of this term from MedDRA Version 2.1 to Version 3.3.
There is a multi-axial link between parent HLGT Administration site reactions and SOC Generaldisorders and administration site conditions and SOC Injury, poisoning and procedural
complications.

1What’s New MedDRA Version 27.0
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Summary of Changes

3. NEW DEVELOPMENTS IN VERSION 27.0
3.1

STANDARDISED MedDRA QUERIES (SMQs)

No new SMQs have been added for MedDRA Version 27.0. There were 248 approved
PT changes to existing SMQs. To view changes to existing SMQs, please review the
MedDRA Version 27.0.

3.2

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 27.0 change request processing period, the MSSO reviewed two
requests and implemented one proactivity proposal. See below for details. 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.
3.2.1 Primary SOC placement of PTs under HLT Oncologic complications andemergencies
In MedDRA 26.0, the primary SOC of PT Malignant ascites was changed from SOC
Neoplasms benign, malignant and unspecified (incl cysts and polyps) to SOC
Gastrointestinal disorders. The justification for this change was that some, but not all,PTs in the HLGT Neoplasm related morbidities that are specific to sites of manifestation
have a primary link to the SOC representative of that site and a secondary link to the
SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps). Based on
this change, a MedDRA user asked the MSSO to review other PTs under HLT
Oncologic complications and emergencies for consistency of placement per the site ofmanifestation rule described above. As a result of this review, the primary SOC of five
PTs were changed. See the table below for details.

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Summary of Changes
PT NameIntracranial tumour
haemorrhage
Malignant pleural effusion
Metastatic pulmonary
embolism
Pericardial effusion
malignantPulmonary tumour
thrombotic microangiopathy

Primary SOC V26.1
Neoplasms benign,malignant and unspecified(incl cysts and polyps)
Neoplasms benign,malignant and unspecified(incl cysts and polyps)
Neoplasms benign,malignant and unspecified(incl cysts and polyps)
Neoplasms benign,malignant and unspecified(incl cysts and polyps)
Neoplasms benign,malignant and unspecified(incl cysts and polyps)

Primary SOC V27.0
Nervous system disorders
Respiratory, thoracic andmediastinal disorders
Respiratory, thoracic andmediastinal disorders
Cardiac disorders
Respiratory, thoracic andmediastinal disorder

Table 3-1 Primary SOC change of PTs under HLT Oncologic complications andemergencies

3.3

NEW MedDRA LANGUAGES DEPLOYED AND UNDER DEVELOPMENT

The MSSO continues to work on new languages to enable more users to apply
MedDRA in their native language and facilitate global communication of MedDRA coded
data. The newest available language is Finnish.
Finnish is part of the 17 European Economic Area (EEA) official languages, approved
for translation by the MedDRA Management Committee in 2020, which are needed tosupport the electronic product information initiative. Note that this initiative includes thetranslation of MedDRA terms only and does not include MedDRA user documentation.
Presently, Bulgarian, Croatian, Icelandic, Lithuanian, Maltese, Norwegian, Romanian,
Slovak and Slovenian translations are EEA languages in development. These
languages will be translated and made available in 2024 or 2025. Please see themultilingual access section 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.

3.4

UPDATE TO APOSTROPHE IN MAINTAINED LANGUAGESThe MSSO discovered that several languages under maintenance had an inconsistency
with how the apostrophe character ' was applied to terms. Some terms used theapostrophe ' (ascii code 039) and others within the same language contained the single
quote ’ (ascii code 0146). Many of these languages use the apostrophe as a diacriticalmark or to indicate the possessive form of a singular noun or a plural noun such as LLTGibert's dandruff. For consistency, the MSSO updated all terms which contained theWhat’s New MedDRA Version 27.0
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Summary of Changes

single quote ’ (ascii code 0146) to the apostrophe ' (ascii code 039) for MedDRA 27.0
and will apply the apostrophe going forward. This update will improve consistency ofsearching in these languages. See the table below for examples and the total number ofterms from all affected languages.
Number ofTerms
Updated in
V27.0

English Term
Name

Language

Term in V26.1

Update in V27.0

Cortical visual
impairment

Arabic‫إ‘اﻗﺔ ﺑﺻرﯾﺔ ﻗﺷرﯾﺔ‬‫ﺿﻌف ﺑﺻري ﻗﺷري‬1

Stahl's ear

Dutch

Stahl’s oor

Stahl's oor

5

Proteus’e test
positiivne
Grosseur au sited’injection

Proteus'e test
positiivne
Grosseur au sited'injection

GermanFall von Hy’s Law

Fall von Hy's Law

GreekΚατ’ οίκον καραντίνα Κατ' οίκον καραντίνα

11

ItalianSordità dell’orecchio
destroSordità dell'orecchio
destro1128

PolishZespół Tourette’aZespół Tourette'a

29

RussianПовышение уровня
5’-нуклеотидазы

Повышение уровня
5'-нуклеотидазы

3

Proteus test
positive
Injection site
lump
Hy's law caseHomequarantine
Deafness rightear
Tourette's
syndrome
5'nucleotidase
increased

Estonian
French782
3032
1

Table 3-2 Examples of Updated Translated Terms

For a detailed list of impacted terms for a specific language, please review therespective MedDRA Version Report in MVAT or the zip file download from the MedDRA
website.
3.5

UPDATED WebCR

WebCR is the web based tool used to submit term changes, SMQ changes andtranslation update requests to the MSSO for consideration in the next MedDRA release.
In November of 2023, the MSSO deployed an updated WebCR application to a modern
software platform with an improved user interface. The updated WebCR performs all of
the same functions as the previous application and includes improved tool tips, error
and warning messages to assist and guide users as they enter and submit changes. In
addition, the color scheme and layout of the updated application will match our SelfService and MapCR applications for consistency across these platforms. Users familiar
with the previous version of WebCR should not have any issues using the updated

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Summary of Changes

version. Please see the Change requests section of the MedDRA website for the
WebCR quick start guide.

Figure 3-1 New LLT request in the updated WebCR application

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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 27.0. For detailed information on the changes to Version 27.0, please see the
MedDRA Version Report in MVAT.
Number ofRecords in
V26.1

Number ofRecords in
V27.0

Changehlgt.asc

337

337

0

hlgt_hlt.asc

1,755

1,756

1

hlt.asc

1,737

1,738

1

hlt_pt.asc

38,38038,749369

llt.asc

87,592

88,345753

meddra_history_english.asc

136,994

138,081

1,087

1

1

0

mdhier.asc

40,61340,994381

pt.asc26,18026,409229

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

94,737

95,501764

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.

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Summary of Changes

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

Currency Status

v26.1

v27.0

LLT

Current Terms

78,28379,026

LLT

Non-current Terms

9,309

9,319

LLT

Total LLTs1

87,592

88,345

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

v26.1

v27.0

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

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 27.0. 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

1

hlt.seq2

hlt_pt.seq

611

llt.seq918

mdhier.seq

1,115

pt.seq333

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

1,273

337

4,680

1,160

87

17

Cardiac disorders

1,609

393

2,677

710

36

10

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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

Congenital,familial andgenetic disorders

4,591

1,841

4,591

1,841

100

19

Ear and labyrinth
disorders

464

104

949

250

17

6

Endocrine
disorders

757

213

2,070

634

38

9

Eye disorders

2,728

685

4,189

1,183

63

13

Gastrointestinal
disorders

4,260

988

8,286

1,958

105

21

General disordersandadministration site
conditions

2,595

1,032

3,639

1,423

36

7

Hepatobiliary
disorders

750

228

1,644

487

19

4

Immune systemdisorders

603

173

3,276

928

26

4

Infections andinfestations

7,821

2,195

8,295

2,330

150

12

Injury, poisoning
and procedural
complications

7,376

1,415

10,585

2,790

79

9

Investigations

15,186

6,350

15,186

6,350

106

23

Metabolism andnutrition disorders

1,064

313

3,147

915

63

14

What’s New MedDRA Version 27.0
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HLTs3 HLGTs3

12

Summary of Changes
SOC

LLTs
(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2

Musculoskeletaland connective
tissue disorders

2,859

532

7,314

1,549

59

11

Neoplasms
benign, malignant
and unspecified(incl cysts andpolyps)

9,113

2,122

10,040

2,489

201

39

Nervous systemdisorders

4,137

1,132

8,303

2,335

108

20

Pregnancy,
puerperium andperinatalconditions

1,729

254

3,135

695

48

8

Product issues

933

180

968

197

21

2

Psychiatricdisorders

2,505

576

3,581

898

77

23

Renal and urinary
disorders

1,317

387

2,843

821

32

8

Reproductive
system andbreast disorders

1,903

550

4,634

1,339

52

16

Respiratory,
thoracic andmediastinal
disorders

1,963

606

4,748

1,318

49

12

Skin andsubcutaneous
tissue disorders

2,404

577

6,087

1,615

56

10

Socialcircumstances

689

300

689

300

20

7

What’s New MedDRA Version 27.0
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HLTs3 HLGTs3

13

Summary of Changes
LLTs(Primary)1

PTs(Primary)1

LLTs(Primary andSecondary)2

PTs(Primary andSecondary)2Surgical andmedicalprocedures

6,240

2,578

6,240

2,578

141

19

Vasculardisorders

1,476

348

7,589

1,901

68

11

Total

88,34526,409SOC

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 27.0
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Summary of Changes

4.4

LLT CURRENCY STATUS CHANGESThe following table reflects 10 terms at the LLT level in MedDRA Version 27.0 that hada change in currency status along with the rationale for the changes.
Currency
StatusChanged to

Rationale

Non-current

PT Aplasia was demoted to an LLT under the new PT
Congenital aplasia added in MedDRA 27.0 and thenchanged to a status of non-current to avoid confusion
with bone marrow aplasia.

Non-current

The expression "benign melanoma" is misleading,potentially causing confusion and is not well recognized
in medical literature.

Gordon syndrome

Non-current

Gordon syndrome is an eponymous term used for bothdistal arthrogryposis type 3 and forpseudohypoaldosteronism type 2, also known as,
familial hyperkalaemic hypertension, which are two
distinct medical conditions. As a result, LLT Gordon
syndrome was changed to a status of non-current due
to the ambiguity of the eponym.

His diseaseNon-current"His disease" is ambiguous and may lead to confusion.
The eponym term LLT Werner-His disease was added
to represent the concept.

Non-current

As "socket" does not only refer to teeth but can also
refer to other locations, e.g. eye socket, the LLTInfected socket was changed to a status of non-current.
New LLT Tooth socket infection was added under PT
Alveolar osteitis to represent the intended concept.

RCL infection

Non-current

RCL infection stands for replication competent lentivirus
infection in the context of PT Lentivirus infection. RCL
can have numerous meanings as a medical
abbreviation such as "recurrent cutaneousleishmaniasis". Therefore, the MSSO changed thestatus of LLT RCL infection to non-current to avoid
confusion.

TLC

Non-current"TLC" could represent total lung capacity, total
leukocyte count or total lymphocyte count. Due to thisLowest Level Term

Aplasia

Benign melanoma

Infected socket

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Summary of Changes
Lowest Level Term

Currency
StatusChanged to

Rationale
ambiguity, this term was changed to a status of noncurrent.

TLC abnormal

TLC decreased

TLC normal

Non-current"TLC" could represent total lung capacity, total
leukocyte count or total lymphocyte count. Due to thisambiguity, this term was changed to a status of noncurrent.

Non-current"TLC" could represent total lung capacity, total
leukocyte count or total lymphocyte count. Due to thisambiguity, this term was changed to a status of noncurrent.

Non-current"TLC" could represent total lung capacity, total
leukocyte count or total lymphocyte count. Due to thisambiguity, this term was changed to a status of noncurrent.

Table 4-6 LLT Currency Changes

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