The Windsor Framework was announced 8 months ago, leading to Regulatory Affairs professionals across the UK to drop their jaws in disbelief, for this meant undoing 2 years worth of work that in many cases had only just finished.
Whilst I can’t deny that I was a jaw dropper, I also recognised the long-term benefits of this Framework in Regulatory Affairs, not to mention our colleagues in Supply Chain and Quality Assurance, and ultimately the patient.
Since the announcement, Industry has been applying pressure to the MHRA for guidance on artwork updates, necessitating a pragmatic and flexible approach. The latest guidance, has provided some of this much needed flexibility for the UK-wide ‘PL’ licences, however it appears it will be trickier to manage the ‘PLGB’ licences.
For those products with shared packs between Ireland and Northern Ireland, the HPRA have communicated a welcomed sensible approach taking some of the burden off of Industry. However many companies are still considering whether it is commercially viable to have a pack only destined for Ireland.
Whilst it’s understandable that Industry isn’t thrilled at the thought of these changes, I find it useful to focus on the long-term benefits this will bring. Since UK medicines will be licensed solely by the MHRA (not shared with EMA), only one pack will be required for the whole of the UK instead of two (i.e. GB and NI), reducing the complexity by effectively removing a market (i.e. NI).
There is no doubt of the negative implications of the Windsor Framework, however I don’t believe these to be long term. It is key to plan early (i.e. now) to decide your submission strategy in order to minimise the impact of additional workload. The 1st Jan 2025 may seem in the distant future, however time travels fast when you work in Regulatory!
Fusion Pharma is closely monitoring the guidance directly from the Health Authorities as well working closely with trade associations. We will be running a live webinar in October to look at the impact to marketed products in more detail.
