Australian Regulator Warns Of Delays To GMP Clearance Processes
Drug sponsors have been told to continue applying for extensions to good manufacturing practice clearances for overseas manufacturing sites as long as they meet the criteria for extension and apply in good time.
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International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine
A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.
EU Adopts New Rules On UK-Wide Approvals For Novel Drugs
Having been passed by the European Parliament and now the Council of the EU, new legislation will clear up some of the issues raised by Brexit relating to trade in medicines between Great Britain and Northern Ireland.
UK In Major Move To Boost Commercial Clinical Trials & Improve Life Sciences Environment
The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.