Problems With UK Pharmacovigilance Master Files Top MHRA’s 2021 Inspection Findings
A senior MHRA inspector says some companies are not clear about the structuring and content of the pharmacovigilance system master file needed for UK authorized products.
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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.
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.
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.