What’s New MedDRA Version 24
CWhat’s NewMedDRA Version 24.0March 2021000550
AcknowledgementsACKNOWLEDGEMENTSMedDRA trademark is registered by ICH.Disclaimer and Copyright NoticeThis document is protected by copyright and may, with the exception of the MedDRAand ICH logos, be used, reproduced, incorporated into other works, adapted, modified,translated or distributed under a public license provided that ICH's copyright in thedocument is acknowledged at all times. In case of any adaption, modification ortranslation of the document, reasonable steps must be taken to clearly label, demarcateor otherwise identify that changes were made to or based on the original document. Anyimpression that the adaption, modification or translation of the original document isendorsed or sponsored by the ICH must be avoided.The document is provided "as is" without warranty of any kind. In no event shall the ICHor the authors of the original document be liable for any claim, damages or other liabilityarising from the use of the document.The above-mentioned permissions do not apply to content supplied by third parties.Therefore, for documents where the copyright vests in a third party, permission forreproduction must be obtained from this copyright holder.What’s New MedDRA Version 24.0March 2021000550ii
Table of ContentsTABLE OF CONTENTS1.DOCUMENT OVERVIEW . 12.VERSION 24.0 CHANGE REQUESTS . 22.1 TERMINOLOGY CHANGES . 22.2 COMPLEX CHANGES . 33.NEW DEVELOPMENTS IN VERSION 24.0 . 53.13.23.33.44.NEW COVID-19 TERMS AND REVIEW OF VACCINE RELATED TERMS . 5STANDARDISED MedDRA QUERIES (SMQS) . 6PROACTIVITY REQUESTS . 6MedDRA APPLICATION PROGRAM INTERFACES IN BETA RELEASE . 6SUMMARY OF CHANGES . 84.14.24.34.44.5SUMMARY OF IMPACT ON THE TERMINOLOGY . 8SUMMARY OF IMPACT ON RECORDS IN MedDRA FILES . 10MedDRA TERM COUNTS . 11MODIFIED PT AND LLT NAMES . 14LLT CURRENCY STATUS CHANGES . 14LIST OF FIGURESFigure 2-1 Net Changes of Terms per SOC . 3LIST OF TABLESTable 2-1 New HLTs . 4Table 2-2 Merged HLTs. 4Table 3-1 New COVID-19 Term Examples. 5Table 3-2 Vaccine Related Term Examples . 6Table 4-1 Summary of Impact on SOCs, HLGTs, HLTs . 8Table 4-2 Summary of Impact on PTs . 9Table 4-3 Summary of Impact on LLTs . 9Table 4-4 Summary of Impact on SMQs . 10Table 4-5 Summary of Impact on Records in MedDRA Files . 11Table 4-6 MedDRA Term Counts . 14Table 4-7 LLT Currency Changes . 15What’s New MedDRA Version 24.0March 2021000550iii
Document Overview1. DOCUMENT OVERVIEWThis What’s New document contains information on the origins and types of changesmade to the Medical Dictionary for Regulatory Activities (MedDRA) between Versions23.1 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 24.0related to change request submissions, new initiatives, information on StandardisedMedDRA Queries (SMQs), and any recent updates to software tools provided by theMSSO.Section 4, Summary of Changes, contains details on: The impact of this version on the terminology (in tables) Impact on the records in MedDRA files MedDRA term and SMQ counts 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 24.0March 20210005501
Version 24.0 Change Requests2. VERSION 24.0 CHANGE REQUESTS2.1TEMINOLOGY CHANGESChanges to MedDRA result from user change requests, from proactivity requestssubmitted by MedDRA users, and from internal change requests. Internal changerequests result from MSSO maintenance activities and from special working groupactivities 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, inaddition, 7 change requests suspended for further consideration and resolution beyondthis version.Information on specific changes (e.g., new terms added, LLT promotions, PTdemotions, PT primary SOC changes, etc.) which occurred since the prior MedDRArelease can be obtained via the Version Report included with each respective MedDRAdownload. In addition, users may wish to use the MedDRA Version Analysis Tool(MVAT) which is an online tool that compares any two MedDRA versions– includingnon-consecutive versions – to identify changes. The output of MVAT is identical to theVersion Report. MVAT is provided free of charge to MedDRA users as part of theirsubscription.Between MedDRA releases, the MSSO makes available weekly supplemental updatefiles, which are approved changes that will be implemented for the next MedDRAversion. Additionally, supplemental changes may be viewed in MedDRA Web-BasedBrowser via the “supplemental view” feature. Supplemental information may be helpfulfor users to identify changes that will be implemented in the next release.An explanation of all changes considered (approved and not approved) for MedDRAVersion 24.0 is accessible as a cumulative Detail Report included in the MedDRAEnglish version download. Users may review all change requests considered by theMSSO from MedDRA Version 5.1 to the present in WebCR.Figure 2-1 (shown below) summarizes all changes made per System Organ Class(SOC) and may be useful to gauge the impact of changes to a specific area ofMedDRA. The data are derived from the difference in counts of primary and secondaryPT/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 24.0March 20210005502
Version 24.0 Change RequestsBlood and lymphatic system disordersCardiac disordersCongenital, familial and genetic disordersEar and labyrinth disordersEndocrine disordersEye disordersGastrointestinal disordersGeneral disorders and administration site Hepatobiliary disordersImmune system disordersInfections and infestationsInjury, poisoning and procedural complicationsInvestigationsMetabolism and nutrition disordersMusculoskeletal and connective tissue Neoplasms benign, malignant and Nervous system disordersPregnancy, puerperium and perinatal Product issuesPsychiatric disordersRenal and urinary disordersReproductive system and breast disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersSocial circumstancesSurgical and medical proceduresVascular 37338148615388Figure 2-1 Net Changes of Terms per SOC2.2COMPLEX CHANGESThe proposals for complex changes considered during Version 24.0 included thosesubmitted by users, special initiatives, and those internally identified by the MSSOduring change request processing.Complex change proposals were posted on the MedDRA website for feedback from theMedDRA user community from 31 July 2020 to 25 September 2020. Complex changeswere followed by further internal review and consensus discussions which resulted inthe final approved set of 7 complex changes.The complex changes implemented in Version 24.0 are summarized below. Please seethe “Related Documents” on the Change Request section of the MedDRA website forspecific details.At the SOC level: No changes were made to existing SOCs.What’s New MedDRA Version 24.0March 20210005503
Version 24.0 Change RequestsAt the HLGT level: No changes were made to existing HLGTs.At the HLT level: There were three High Level Terms (HLTs) added and four mergedas a result of complex changes in Version 24.0. The changes are as follows:New HLTsNew HLTTo SOCAuditory and vestibular diagnosticproceduresInvestigationsFollicular lymphomasMulti-axial to Blood and lymphatic systemdisorders and Neoplasms benign,malignant and unspecified (incl cysts andpolyps)Hepatitis virus infectionsInfections and infestationsTable 2-1 New HLTsMerged HLTsHLTAuditory function diagnosticproceduresTo HLTAuditory and vestibulardiagnostic proceduresFollicle centre lymphomasdiffuse predominantly smallcellFollicular lymphomasFollicle centre lymphomas,follicular grade I, II, IIIFollicular lymphomasHepatitis viral infectionsHepatitis virus infectionsSOCInvestigationsMulti-axial to Blood andlymphatic system disordersand Neoplasms benign,malignant and unspecified(incl cysts and polyps)Multi-axial to Blood andlymphatic system disordersand Neoplasms benign,malignant and unspecified(incl cysts and polyps)Infections and infestationsTable 2-2 Merged HLTsWhat’s New MedDRA Version 24.0March 20210005504
New Developments in Version 24.03. NEW DEVELOPMENTS IN VERSION 24.03.1NEW COVID-19 TERMS AND REVIEW OF VACCINE RELATED TERMSThe 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 onthe COVID-19 section of the MedDRA website. See the table below for severalexamples:LLTPTHLTPrimary SOCCongenital SARS-CoV-2infectionCongenital COVID-19Viral infectionscongenitalCongenital, familialand geneticdisordersLaboratory confirmedSARS-CoV-2 infectionwithout nfections andinfestationsLong COVIDPost-acute COVID-19syndromeCoronavirusinfectionsInfections andinfestationsCOVID-19 screeningCOVID-19 screeningVirus identificationand serologyInvestigationsTable 3-1 New COVID-19 Term ExamplesWith 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 proactivelyreviewed the vaccine-related terms in MedDRA and solicited feedback from aninternational group of regulatory and industry users on the MSSO’s proposals for newterms for Version 24.0, as well as any other potential terms for additions. As a result ofthis review, 15 new terms and changes were implemented in Version 24.0. See thetable below for several examples which include certain Adverse Events FollowingImmunisation (AEFI) relevant for SARS-CoV-2 vaccines:PTHLTPrimary SOCVaccine associatedenhanced diseaseImmune and associatedconditions NECImmune system disordersVaccine derived SARSCoV-2 infectionCoronavirus infectionsInfections and infestationsWhat’s New MedDRA Version 24.0March 20210005505
New Developments in Version 24.0PTHLTPrimary SOCSARS-CoV-2 RNAincreasedVirus identification andserologyInvestigationsAcute aseptic arthritisArthropathies NECMusculoskeletal andconnective tissue disordersBell’s palsy (promoted fromPT Facial paralysis)Facial cranial nervedisordersNervous system disordersTable 3-2 Vaccine Related Term Examples3.2STANDARDISED 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 theMedDRA Version 24.0 Version Report.3.3PROACTIVITY REQUESTSThe proactive maintenance process allows MedDRA users to propose general changesto MedDRA outside of the established change request process. These proactivityrequests may address inconsistencies, make corrections, or suggest improvements.During the Version 24.0 change request processing period, there were no open orimplemented proactivity requests. The MSSO publishes and updates a list of allproposals received and their status on the Change Request section of the MedDRAwebsite.The MSSO is interested in learning about any ideas that users may have about“proactive” improvements to MedDRA. Please email your ideas for “proactive” MedDRAimprovements to the MSSO Help Desk. Be as specific as possible in describing yoursuggestion(s), and include a justification which explains why you think your proposalshould be implemented.3.4MedDRA APPLICATION PROGRAM INTERFACES IN BETA RELEASEAs of January 2021, the MedDRA Application Program Interfaces (APIs) are nowavailable to MedDRA users in a Beta release phase. The MSSO will begin work onextending and formalizing API information to align with “Good practice” (GxP) qualityguidelines 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.What’s New MedDRA Version 24.0March 20210005506
New Developments in Version 24.0The MedDRA APIs provide similar features and functions to the Web-Based Browserand 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 APIpage are a programmer’s guide, input examples and answers to frequently askedquestions.What’s New MedDRA Version 24.0March 20210005507
Summary of Changes4. SUMMARY OF CHANGES4.1SUMMARY OF IMPACT ON THE TERMINOLOGYThe tables below (Tables 4-1 through 4-5) summarize the impact on MedDRA inVersion 24.0. These tables are intended only as a reference. For detailed information onthe changes to Version 24.0, please see the MedDRA Version Report included withinthe MedDRA download or in MVAT.SOC, HLGT, HLT ChangesLevelChange Request Action Net Change v23.1 v24.0SOCTotal SOCs02727New HLGTs000Merged HLGTs000Total HLGTs10337337New HLTs303Merged HLTs404Total HLTs1-11,7381,737HLGTHLTTable 4-1 Summary of Impact on SOCs, HLGTs, HLTs1Total net change of HLGTs or HLTs equals the number of new HLGTs or HLTs minusthe number of respective merged HLGTs or HLTs.What’s New MedDRA Version 24.0March 20210005508
Summary of ChangesPT ChangesLevel Change Request ActionPTv23.1v24.0New PTs274262Promoted LLTs1523Demoted PTs3136Net Change125824924,57124,820Total PTsTable 4-2 Summary of Impact on PTs1Netchange of PTs equals the number of new PTs plus the number of promoted LLTsminus the number of demoted PTs.LLT ChangesLevelCurrency StatusNet Changev23.1v24.0LLTCurrent Terms70773,28473,991LLTNon-current Terms19,2999,300LLTTotal LLTs170882,58383,291Table 4-3 Summary of Impact on LLTs1TotalLLTs include PTs as they are also in the LLT distribution file.New SMQsLevel Net Changev23.1v24.010108108208282302020What’s New MedDRA Version 24.0March 20210005509
Summary of ChangesLevel Net Changev23.1v24.04016165022Table 4-4 Summary of Impact on SMQs4.2 SUMMARY OF IMPACT ON RECORDS IN MedDRA FILESThe table below summarizes the impact on MedDRA in Version 24.0. The table isintended only as a reference.INTL ORD.ASCSOC.ASCSOC HLGT.ASCHLGT.ASCHLGT HLT.ASCHLT.ASCHLT PT.ASCMDHIER.ASCWhat’s New MedDRA Version 24.0March d010
Summary of CSMQ LIST.ASC1SMQ dified228Added874Removed0Modified222Table 4-5 Summary of Impact on Records in MedDRA Files1 Thenumber of SMQs added includes both top level (Level 1) and sub-search SMQs.4.3MedDRA TERM COUNTSThe table below shows term counts by SOC for HLGTs, HLTs, primary and secondaryPTs and LLTs, and primary PTs and LLTs. Note that the number of LLTs also y andSecondary)2PTs(Primary andSecondary)2Blood andlymphatic systemdisorders1,2113094,4681,0878717Cardiac disorders1,5103672,4996583610Congenital,familial andgenetic disorders4,1731,6584,1731,65810019Ear and labyrinthdisorders44796893233176SOCWhat’s New MedDRA Version 24.0March 2021000550HLTs3 HLGTs311
Summary of ChangesLLTs(Primary)1PTs(Primary)1LLTs(Primary andSecondary)2PTs(Primary andSecondary)26981981,907581389Eye orders4,0459317,8891,83910521General disordersandadministration disorders7042171,556461194Immune systemdisorders5441572,950828264Infections andinfestations7,5122,0797,9152,19715012Injury, poisoningand stigations14,3526,00214,3526,00210623Metabolism andnutrition disorders1,0062952,8928386314Musculoskeletaland connectivetissue disorders2,7034976,9511,4415911Neoplasmsbenign, malignantand sordersWhat’s New MedDRA Version 24.0March 2021000550HLTs3 HLGTs312
Summary of ChangesLLTs(Primary)1PTs(Primary)1LLTs(Primary andSecondary)2PTs(Primary andSecondary)2Nervous puerperium andperinatalconditions1,6782393,008651488Product ,3948517723Renal and tem andbreast c andmediastinaldisorders1,8465774,5061,2464912Skin andsubcutaneoustissue ical lardisorders1,4133337,1821,7866811SOCHLTs3 HLGTs3(incl cysts andpolyps)SocialcircumstancesWhat’s New MedDRA Version 24.0March 202100055013
Summary of ,820LLTs(Primary andSecondary)2PTs(Primary andSecondary)2HLTs3 HLGTs3Table 4-6 MedDRA Term Counts1Primarycount 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 4-3.2Totalcount includes the number of terms that are both primarily and secondarily linkedto the designated SOC at either the LLT level or the PT level. Therefore, the sums oftotal LLTs and PTs are greater
This 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 summ
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This What’s New document contains information on the origins and types of changes made to the Medical Dictionary for Regulatory Activities (MedDRA) between Versions 23.0 and 23.1. Section 2, Version 23.1 Change Requests, provides a summ
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Last previous edition approved in 2018 as A234/A234M – 18. DOI: 10.1520/A0234_A0234M-18A. 2 For ASME Boiler and Pressure Vessel Code applications see related Specifi-cation SA-234 in Section II of that Code. 3 For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards volume information, refer .
