WORRIED ABOUT THE IMPACT OF BREXIT ON YOUR CLINICAL TRIALS?
As we see it, you have a choice. Will you wait to see what the impact of Brexit will be and hope your trial is not disrupted? Or, as we recommend, will you take preemptive action and choose CSM to manage your clinical trials within the future European Union and mitigate the risk NOW?
Since Friday, January 31 2020, the UK is no longer a member of the European Union. The objective is to finalize a trade deal by the end of the year. For clinical trials it will be a drawn-out process, given the complexity of the existing regulatory regime. Although the UK government wants to align "where possible" with the EU Clinical Trials Regulation (CTR), trial participants in the UK and recruitment for future international trials could be affected.
This is why we’ve made it a priority to look into how Brexit might affect your clinical trials in the future. At CSM we have positioned ourselves in such a way that we are able to successfully address Brexit no matter what the outcome will be.
Given that clinical trials are planned well in advance, and cannot simply stop mid-trial, there is a lot of uncertainty surrounding the studies that will start during the time period leading up to the trade deal deadline. It is likely that UK-based Qualified Persons (QPs), who are essential to European pharmaceutical manufacturing, will no longer be able to certify clinical trial batches for the European Union. With 25% of the European Union's QPs based in theUnited Kingdom, it is possible there will be a shortage of QPs after December 2020.
Our EU GMP facilities in Brussels and Frankfurt are staffed with certified QPs who can support your drug product EU release and batch certification. Both facilities have decades of experience and outstanding quality and regulatory track records. Moreover, being part of the Clinigen Group, CSM has access to its own depots within the UK, staffed with UK QPs. This allows CSM to store IMPs for clinical trials in the UK and provide optimum cost and time efficiency.
For more information, read CSM’s full article on Brexit, where you will learn more about how CSM is prepared to roll with the punches, and download our free whitepaper on Brexit and Biotech.
BREXIT: IT’S A TOUGH PILL TO SWALLOW
Many pharmaceutical companies running clinical trials in Europe work with contract research organizations (CROs) and contract manufacturing organizations (CMOs) based in the UK.
As of January 1 2021, the UK and UK-based CROs and CMOs will legally no longer be part of the EU which will have a dramatic effect on the European portion of the global ecosystem of testing or distributing investigational medicinal products (IMPs).
The impact on the supply chain of clinical trials could completely derail the development of a new drug, with significant negative financial and economic consequences. The complexity of the European clinical trial supply chain means that arrangements need to be made NOW to avoid shortages, or delays, to medicines reaching patients in the UK and mainland Europe.
For more information, read this Case Study about the EU Release and the Importation of IMPs in the EU. CSM helped a contract manufacturing organization (CMO) take an investigational medicinal product into Europe. Certified on time, the clinical trial was carried out in full compliance thanks to our attention to detail.