Brexit & COVID-19 Bring New Roles For UK Biological Medicines Control Lab
Newly Standalone NIBSC To Help Standardize Vaccine Response Testing
One effect of Brexit is that the UK’s National Institute for Biological Standards and Control will have additional responsibilities from next year in terms of the independent batch testing and release of products such as vaccines and medicines derived from human blood and plasma in Great Britain.
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Two new projects have begun, one on standardizing the assessment of immune responses in individuals vaccinated in clinical trials, the other to improve understanding of potential immunity in patients who have been infected with SARS-CoV-2.
The EU pharmaceutical strategy published on 25 November will be the first step in a “complete overhaul” of the medicines legislative framework to be proposed in about two years’ time, says the European Commission.
EU and UK regulators are vying for vaccine filings, and the EMA will consider changing the terms of the marketing authorization for remdesivir after a WHO panel advised against its use in COVID-19. An Austrian biotech firm is investigating the prophylactic potential of a carrageenan-based spray.