4/16/2020

1

MedDRA 23.0 UpdateMr. Patrick Revelle, Director, MedDRA MSSO

Dr. Judy Harrison, Chief Medical Officer, MedDRA MSSO

17/20 April 2020

Webinar

Topics

• Background

• Scope of Update

• Global Transition Date

• Release Package Details

• Questions received to date

• Other Questions?

2

4/16/2020

2

MedDRA and COVID-19

• ICH MedDRA Management Committee has decided to update MedDRA 23.0 to include COVID-19 related terms– Exceptional change to the standard release

schedule

– Necessary to ensure that any scientific and medical information from the COVID-19 outbreak can be captured, shared, and analyzed appropriately

3

MedDRA 23.0 Update

• To be released on 19 April 2020

– English (MSSO) and Japanese (MSSO and JMO)

– Release package will include all usual files

– Release will include all terms from the original MedDRA 23.0 release plus the ~70 new COVID-19 related terms and revisions to a few terms

– This version replaces the original MedDRA 23.0 release

4

4/16/2020

3

MedDRA 23.0 Update

(cont)

• HLT Coronavirus infections added to group these infections

5

MedDRA 23.0 Update

(cont)• Investigation terms

• Treatment, immunisation, quarantine terms in SOC Surgical and medical procedures

• Exposure terms in SOC Injury, poisoning and procedural complications

6

4/16/2020

4

MedDRA 23.0 Update

(cont)

• Regulatory authorities and industry users are urged to load this updated version in line with the global transition date for MedDRA on 4 May 2020

– Necessary for regulatory authorities to load the new version to avoid report rejections

7

Global Transition Date

• 4 May 2020– First Monday of the Second month following the release

in March 2020

• We understand that this gives a short time to up-version to this new release– Regulators on the MedDRA Management Committee have

agreed that internal process-related activities (e.g., training on the use of the additional COVID-19 terms) can be done at a reasonable time after the implementation on 4 May

– MedDRA Management Committee encourages other regulators to show flexibility as well

8

4/16/2020

5

Release Package

9

All 14 release files included

All 10 sequential files included*

*

*

Document describes this special release

Only file record counts updated to support validation

* Updated files or documents

*

*

MedDRA 23.0 Updated

Translations

• Updated translation release packages will be released by 3 May

– Same format and file updates as English

– Updated translation release packages will be clearly identified

– Translations will be posted as they are available• Check Downloads page periodically for specific language versions

10

4/16/2020

6

Main Page Screenshot

• <Screenshot>

11

Dedicated COVID-19

Page

• Updated with messages and links to COVID-19 related information 12

4/16/2020

7

Downloads Page

13UPDATE versions marked, translations posted as available but all by 3 May

Link to COVID-19 related terms and revisions spreadsheet

List of COVID-19 Terms in

the MedDRA 23.0 Update

14

• Provides all new and changes to COVID-19 related terms and revisions• Includes identifier for terms to include in a COVID-19 search

4/16/2020

8

MedDRA Version 23.1

• Normal release schedule

15

Questions and Answers

1. Do I have to implement the updated v23.0 in my system by the transition date of 4 May?You are urged to do so. Important if exchanging data.

2. What is the cut-off date for Change Requests for v23.1?1 June 2020

3. Can I still submit Change Requests for other COVID-19 related terms? By 1 June 2020 for v23.1By 1 December 2020 for v24.0Please check supplemental view in Web-Based Browser or MVAT to check if the term has already been submitted by someone else

16

4/16/2020

9

Questions and Answers

(cont) 4. Will there be an update to the Points to Consider documents for the new COVID-19 terms?No special update

5. When will the new terms be added to existing SMQs?More information will follow shortly. SMQ Infective pneumonia and SMQ Opportunistic infections impacted.

6. What strategies can we use to search for/retrieve relevant terms in the interim?See COVID-19 Related Terms spreadsheet for search list and strategy – new HLT and individual PTs/LLTs identified

7. Will there be an SMQ for COVID-19?Under consideration

17

Questions and Answers

(cont)

8. I already have cases coded using existing coronavirus terms. Should I re-code my data? Usual practices apply

9. Will there be an update to EMA’s v23.0 Important Medical Events (IME) List?Yes. To include certain COVID-19 terms. Coming shortly.

10. Will the new COVID-19 terms be included in the MedDRA-SNOMED CT maps? Yes. To be coordinated with SNOMED International for the April 2021 first production release.

18

4/16/2020

10

Regulatory Information and

Guidance Regarding COVID-19

• EMA– New treatments and vaccines– Clinical trials– Medicines availability– Safety of medicines

https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19#advice-on-safety-of-medicines-in-covid-19-patients-section

• FDA, United States– Clinical trials

https://www.fda.gov/media/136238/download

– Post marketinghttps://www.fda.gov/media/72498/download

19

Regulatory Information and

Guidance Regarding COVID-19

(cont)

• MHRA, UK– Clinical trialshttps://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19#reporting-of-serious-adverse-events-saes-and-submission-of-annual-safety-reports-dsurs-and-end-of-trial-notifications

• Health Canada, Canada– Clinical trials

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/management-clinical-trials-during-covid-19-pandemic.html

• PMDA, Japan– Clinical trials

https://www.pmda.go.jp/english/int-activities/0002.pdf

20

4/16/2020

11

Open Questions and Answers

21

Questions?