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Global Pharma Guidance Tracker – February 2022

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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UK MHRA Specifies Eligibility For Consultancy Firms To Monitor GMP, GDP Compliance

Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements. 

Digital Data Deluge Can Affect Oversight Of Patient Safety In Trials

The digitalization of clinical trials is generating more patient safety data than companies can process. A senior EMA official says sponsors should carefully select what is needed to maintain appropriate subject oversight by “getting the science right.”

Companies Urged Not To View EU Privacy Law As A Barrier To Conducting Decentralized Trials

A senior regulator from the European Medicines Agency says that while the EU General Data Protection Regulation can be intellectually challenging, the law is needed, and it should not deter companies from conducting decentralized clinical trials because of concerns they might have over the use digital tools to capture and process patient and trial data.

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