On 24th January 2023, the MHRA announced that further to the recent extension of the European Commission Decision Reliance Procedure (ECDRP) route to 31st December 2023, from 1st January 2024, there will be a new international recognition framework in place to replace it.

Details are still forthcoming, but the good news is that applications through this new framework will continue to have regard to decisions already made by the European Medicines Agency. The even better news is that this framework will extend beyond Europe to “certain other regulators”, allowing even greater flexibility for UK regulatory strategy and increasing routes to market in the UK.

At Jenson R+ we have been utilising both the ECDRP and its sister procedure, the decentralised and mutual recognition reliance procedure (MRDCRP), since their inception post-Brexit. This has given us a wealth of experience in the nuances, advantages and challenges of each.

There are many advantages to the ECDRP route for your UK business, not least the opportunity to keep product information harmonised across Great Britain and Northern Ireland (as well as other English-language pack countries such as Ireland, Malta, and Cyprus), as under the Northern Ireland protocol medicines marketed in this region must follow European regulations. This can be of great benefit for your supply strategy, as well as PI lifecycle management.

Reliance routes can also help to reduce regulatory workloads (both at a company and agency level) as well as overall approval timelines, although it is important to understand that new procedures as well as some variations will lag behind EU approvals when using this route, so careful management of critical applications and changes is key.

The expert medicines team at JensonR+ can help you navigate the complexities of the post-Brexit UK regulatory landscape, supporting you in creation of the best regulatory strategy to bring your medicines to the UK market quickly, efficiently and compliantly.

For more information please get in touch at consultancy@jensongroup.com.