Latest from Eliza Slawther
Companies have until 17 March to respond to an EU consultation on a new strategy that will seek to simplify the regulatory framework and make it easier for innovative small and medium-sized enterprises to “access the capital they need” to scale up in the bloc.
An enhanced role for patients in the European Medicines Agency was a key proposal within the EU pharmaceutical legislation overhaul – but patient groups warn this provision could be scrapped or weakened due to ongoing negotiations.
The UK drug regulator has made a number of improvements to its innovative licensing and access pathway, including a more “core” role for National Health Service partners, which is expected to facilitate flexible commercial discussions around drug reimbursement.
The European Commission has confirmed that pharmaceutical companies will be able to request access to data for research under the new European Health Data Space Regulation, which has been published in the EU Official Journal and will enter into force on 26 March.
Lawrence Tallon has been announced as the new CEO of the UK drug regulator, the MHRA, more than a year after its current CEO, Dame June Raine, announced she would retire from the role.
Companies that fail to provide patient health data for secondary use when requested under the new European Health Data Space could be fined and also prevented from making access requests from other entities, a European Commission representative says.