On 23rd of June this year the very surprising result of a referendum in the UK was broadcasted. With a small majority, Britain voted to leave the European Union, which leads to several regulatory related questions:
- Are there any immediate actions every regulatory professional need to take care of?
- What regulatory implications do we have to start preparing for mid term ?
- What different types of exit scenarios are possible ?
- What are the implications for a distributed EU wide manufacturing setup ?
- What will happen with EMA related activities ?
- Will EMA remain in the UK ?
- What will be the status of MHRA in cooperation with other European NCA’s ?
- And more…..
At the moment we cannot answer these questions in detail. What we can do, and this is our recommend best practice approach, is to establish a company internal task force, with the current objective to list all possible implications and questions.
EMA recently published an update in which is described, that since this never happened before, there are no fixed procedures and for now everything remains untouched. However, there will be some challenges.
The recently published EFPIA statement might also be helpful.
Bloomberg published a valuable article about the opinion of Severin Schwan (Roche Holding AG Chief Executive Officer) in this matter:
In summary we can state with confidence, that there is a lot of work ahead, but for now there are no immediate actions required other than information gathering.
Sign up for our newsletter and stay informed on publications and guidelines, that we would broadcast once available.
Your Cunesoft Team