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Global Pharma Guidance Tracker – December 2021

Executive Summary

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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COVID-19 Redefining Clinical Trial Transparency Expectations & Challenges

A senior Pfizer executive talks about the high regulatory expectations for public disclosure of clinical trial data for Comirnaty, the COVID-19 vaccine it developed in partnership with BioNTech. There were also concerns about re-identification of trial participants as many subjects took to social media to share their experiences with the Comirnaty study.

Care Needed With Plain Language Summaries Of EU Study Results

The EU will make it mandatory for clinical trial sponsors to prepare layperson summaries of their study results. Industry practices around content presentation, translation and dissemination of these documents will be keenly watched.

New EU Clinical Trials Transformation Initiative Gets Underway

Days before the EU Clinical Trial Regulation is set to come into effect, a new initiative has been launched to track and support its successful implementation and help deliver other trial-related reforms. 

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