8/23/2019 1 What’s New with MedDRA Version 22.1 and the MSSO David W. Richardson, M.D. Medical Officer, MedDRA MSSO 28 & 29 August 2019 MedDRA was developed under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The activities of the MedDRA Maintenance and Support Services Organization (MSSO) are overseen by an ICH MedDRA Management Committee, which is composed of the six ICH parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Health Canada, and the WHO (as Observer). 2 000363
Transcript
8/23/2019
1
What’s New with
MedDRA Version 22.1
and the MSSO
David W. Richardson, M.D.
Medical Officer, MedDRA MSSO
28 & 29 August 2019
MedDRA was developed under the auspices of the
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The activities of the MedDRA Maintenance and Support Services Organization (MSSO) are overseen by an ICH MedDRA Management Committee, which is composed of the six ICH parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, Health Canada, and the WHO (as Observer).
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Disclaimer and
Copyright Notice
• This presentation is protected by copyright and may, with the exception of the MedDRA and ICH logos, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the presentation is acknowledged at all times. In case of any adaption, modification or translation of the presentation, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original presentation. Any impression that the adaption, modification or translation of the original presentation is endorsed or sponsored by the ICH must be avoided.
• The presentation is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original presentation be liable for any claim, damages or other liability arising from the use of the presentation.
• 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 for reproduction must be obtained from this copyright holder.
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Topics
• What’s New with Version 22.1 –Summary of Changes (including SMQs)
• MedDRA Translations• Proactive Maintenance• Update on Points to Consider (PtC) Documents• New MSSO Staff• Social Media Initiatives• Update on MedDRA IT Tools• MedDRA Training• Upcoming Meetings• Other Topics
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What's New with
MedDRA Version 22.1
MedDRA Version 22.1
• Release on 1 September 2019
• A simple release
• Change request summary:
–MSSO considered 1,533 change requests, including SMQ requests (not including translation updates)
• Approved: 1,358
• Not approved: 174
• Suspended: 1
• Changes reflect the differences between v22.0 and v22.1
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Net Change of Terms
per SOC
767
92
6
101
55
89
16
21
16
31
115
24
58
31
190
122
70
61
7
71
52
52
22
6
68
11
31
Vascular disorders
Surgical and medical procedures
Social circumstances
Skin and subcutaneous tissue disorders
Respiratory, thoracic and mediastinal disorders
Reproductive system and breast disorders
Renal and urinary disorders
Psychiatric disorders
Product issues
Pregnancy, puerperium and perinatal conditions
Nervous system disorders
Neoplasms benign, malignant and unspecified (incl…
Musculoskeletal and connective tissue disorders
Metabolism and nutrition disorders
Investigations
Injury, poisoning and procedural complications
Infections and infestations
Immune system disorders
Hepatobiliary disorders
General disorders and administration site conditions
Gastrointestinal disorders
Eye disorders
Endocrine disorders
Ear and labyrinth disorders
Congenital, familial and genetic disorders
Cardiac disorders
Blood and lymphatic system disorders
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Version Report
• List of various types of changes in MedDRA
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• One new SMQ added
• See MedDRA Version 22.1 SMQ Introductory Guide for detailed information on new SMQ Sepsis
• Additional changes made to existing SMQ Agranulocytosis
• 105 level 1 SMQs in production
• 331 changes made in existing SMQs, see the Version Report
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