The UK is signing up to two international collaborative programmes to coordinate regulatory approval of innovative medicines with other countries.
Members of the European Union operate closely coordinated medicines approval systems, with innovative products coming within the remit of the EMEA for central approval. Outside the EU, the UK will no longer be able to access this system in the same way. There may, of course, be future collaboration with the EU system but this remains uncertain.
Meanwhile, signing up to other international programmes offers a new type of collaborative opportunity.
- Project Orbis
This is a programme focused on promising cancer treatments. Coordinated by the US Food and Drug Administration, and involving Canada, Australia, Switzerland, Singapore and Brazil, the programme works to review and approve promising new medicines.
- Access consortium
This programme involves Australia, Canada, Switzerland and Singapore working together on review of new products.The consortium has previously approved nine innovative prescription medicines, of which five were new cancer treatments.
As well as sharing workload among regulators, this approach can help to make new medicines available in all member countries at the same time.
This article was written by Medilink EM Patron, Mills and Reeve LLP.
