UK/EU Industry ‘Still Working In The Dark’ On Post-Brexit Regulation
Manufacturing & Northern Ireland The Most Taxing Issues
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.
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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.
The Northern Ireland Protocol brings added complexities that for medicines regulation in the UK, particularly in areas such as new drug approvals and batch release procedures.
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.