NICE and MHRA work closer to deliver innovative medicines faster
In the recent Life Sciences Sector Plan, one of the promises to make the UK the third best place in the world for life sciences was to streamline regulation and market access.
The MHRA regulates whether medicines can be licensed to be marketed in the UK - determining that they are safe and make a positive impact on patients. NICE then usually determines whether those medicines are value for money at the price being offered by suppliers.
In a joint information sharing agreement between the MHRA and NICE, pharmaceutical suppliers are going be invited to register early with both organisations in order to enable the parallel decision making over both licensing and value.
This will mean that medicines will be approved for use on the NHS in England concurrently with being licensed for use in the UK. It is expected that this move could benefit patients in England by receiving the newest medicines three to six months earlier as a result. Apart from benefiting patients, I see this as further underscoring why the UK is a great place to be to launch a new medicine.
The announcement has been hailed by all parts of the sector - from the ABPI for branded medicines to Medicines UK who are pleased with the effect this will have on biosimilars.
I'd be interested to hear any thoughts you have on this announcement? Do contact me on pgershlick@vwv.co.uk