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Global Pharma Guidance Tracker – October 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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UK MHRA On ‘Steep Learning Curve’ For Post-Brexit Safety Reporting

The UK medicines regulator has made changes to its guideline on pharmacovigilance procedures to ensure it can continue receiving all necessary safety information in a timely manner now that it has left the EU. It has also explained the safety reporting procedures for products marketed in Northern Ireland, which are still governed by EU medicines regulations. 

ICH Makes Progress On Tackling Safety Data ‘Overload’

Changes to an ICH guideline could help drug companies that are being deluged with post-approval safety information to cut down on noisy, low-value data.

EMA To Consider How To Deliver Drug Risks Information Via Digital Formats

European Medicines Agency plans to finalize changes to its guideline on additional risk minimization measures and then establish a new drafting group on digitalization of education materials.

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