Brexit: UK Industry Body Slams 'Ill Considered' Guidance On Batch Testing
Time Limit Placed On Acceptance Of Overseas Test Results
The UK BioIndustry Association says the updated guidance will result in duplicative and costly repetition and dent industry’s confidence in the government’s competence.
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As the final scheduled round of post-Brexit trade talks begins amid growing concern over the prospect of a deal and the pervasive threat of COVID-19, pharmaceutical industry bodies in the UK and the EU have issued an urgent call for an MRA on medicines GMP. They also want to see a one-year phase-in of medicines-related aspects of the Northern Ireland Protocol.
New guidance documents issued by the UK regarding medicines regulation after the end of the Brexit transition period cover the import of medicinal products from countries on an approved list, trade in APIs between the UK and third countries, and the acceptance of batch testing under existing mutual recognition agreements.
A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.