Global Pharma Guidance Tracker – May 2021
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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The MHRA intends to drop around 300 roles as it faces a financial crunch after leaving the EU and other pressures.
The Association of Contract Research Organizations’ revised toolkit on decentralized trials explains how to deal with data quality and integrity.
The European Medicines Agency has updated its reflection paper on methodologies for comparative quality assessment. The paper clarifies expectations on the assessment of similarity for manufacturing changes and for generic and biosimilar development by introducing the concept of “similarity condition.”