New ATMP certification process nears adoption
This article was originally published in Scrip
A new procedure intended to streamline the evaluation of advanced therapies from smaller biotech firms is expected to be in place within the next month or so.
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The Conservative Party's victory in the UK general election means the Brexit withdrawal deal will be able to pass. The UK will leave the EU by 31 January and enter a transition period during which medicines regulation will remain broadly unchanged.
Health ministers have called for more action on access to medicines, including a new EU work agenda, rebuilding Europe’s manufacturing capabilities, further action on pricing, and greater leeway for member states to mitigate drug shortages by restricting parallel exports.