New Anonymisation Report Form Template EMA/Health Canada released today

New Anonymisation Report Form Template EMA/Health Canada released today

Today, EMA & Health Canada released a new Anonymisation Report Form Template they have developed jointly.

Form & 11-page instructions can be downloaded at:

https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/support-industry-clinical-data-publication

Shubhechha Bansod

Clinical Medical Editor

8 个月

For submitting one joint Clinical Data Publication package to both EMA and Health Canada what option are we supposed to select in the overlay text section in the new anonymisation report template? Because as of now we can only select any one PPD or PI. If you could please give your opinion on this.

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