It is hoped that the single site will help to improve the lives of patients and their families by developing medicines as quickly as possible.
The Medicines and Healthcare products Regulatory Agency (MHRA) has helped Eisai, a leading Japanese pharmaceutical company, to develop its first European site.
The third case study, published today, illustrates how MHRA advised on the regulatory requirements Eisai needed for the innovative concepts and design philosophies they wanted to employ in the development of Eisai’s European Knowledge Centre.
It is hoped that the single site will help to improve the lives of patients and their families by developing medicines as quickly as possible.
Mark Birse, MHRA GMDP Group Manager Inspections, Enforcement and Standards said:
“It can be tricky to balance the desire to employ innovative features in site development with the need to meet regulatory requirements. At MHRA we understand this tension and we work to help companies push the boundaries, but crucially within the parameters of safe and secure regulation. Our Innovation Office is the best way to access the information and guidance you need to save time, money and to safeguard your investment in the UK.”
MHRA helped in a number of ways:
- attending advisory meetings to facilitate quick decision making
- reviewing the conceptual approach to make sure it was on the right track
- providing invaluable feedback at an early stage, helping Eisai to mitigate risk and avoid expensive changes to design later on in the process
- working to support Eisai in ensuring compliance
Alex Felthouse, Director of Engineering and Production Services, Eisai said:
“Establishing a presence in Europe was of strategic importance to us. Involving the MHRA Inspectorate early on in the design of our flagship research and production site really helped us to make sure we were developing something that was within the regulatory parameters for this type of site, particularly as we were planning to build in a variety of innovative features. We were able to access guidance and advice quickly and easily as the project developed, helping us to minimise risk and the potential for expensive and time-consuming changes to the site.”