RE: Hopefully New regulations coming into place17 Mar 2025 11:41
From the action plan:
'The UK will be the first country in the world to bring the delivery of innovative and personalised medicines ever closer to patients. From July 2025, new regulations will allow the safe development of highly personalised and critical medicines to be manufactured and supplied for patients in hospitals or in their homes, at the point of care. Making it easier to manufacture innovative medicines in the UK will increase the attractiveness of the UK as a destination to market new life-saving medicines'
'NICE is continuing to transform its Technology Appraisal process, building on its success reducing evaluation times by a quarter in the last year. This year 40% of Technology Appraisals were completed in 240 working days after Marketing Authorisation, and NICE’s transformation will reduce this further to 60% for appraisals started in 2025/26'
'Improve alignment between MHRA decision and NICE guidance publication - The MHRA and NICE will tackle information sharing and collaboration between technical experts to remove delays to patient access to medicines. This pilot will see the MHRA and NICE exploring the development of a joint process to provide a new offer to industry: concurrent marketing authorisation (from the MHRA) and technology appraisal (from NICE), enabled by enhanced data sharing and collaboration between technical teams, saving time and delivering further efficiencies intended to benefit industry and patients.'
'Integrated pre-market scientific advice - Working in partnership, the MHRA and NICE will launch a fully ‘Integrated Scientific Advice’ service, accessed through a single point of entry. The new service will further establish the UK as a primary destination for clinical trials and investigations while ensuring translation of investigative medicines and medical devices to licensed products and quicker access to the healthcare system'
This is the year for GDR