Brexit: Life Science Firms In An ‘Impossible Position’
Guidance Still Awaited On Licensing & Pharmacovigilance
As negotiations between the UK and EU enter a crucial phase, the UK life sciences industry has called for more clarity and guidance on what companies can expect to face at the end of the Brexit transition period.
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The pharmaceutical industry has welcomed a decision to allow more time to bring in new medicines regulations in Northern Ireland, but continues to insist that a mutual recognition agreement between the UK and the EU on drug manufacturing is the best way forward.
Two new quality guidelines are needed to address the increase in applications for clinical trials and marketing authorizations of oligonucleotide- and peptide-based medicines, says the EU regulator.
The European Commission has laid out a number of possibilities for changing the EU framework on compulsory licensing to improve the availability of products in health emergencies. The options include extending the scope of compulsory licences beyond patents to other forms of protection such as data exclusivity.