Since January 31 2020, the UK is no longer a member of the European Union. The transition period, during which the UK continued to remain under EU pharmaceutical law, came to an end on December 31 2020. From January 1 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator.
Transitioning to a clinical services provider with the expertise to handle the post-Brexit scenario to manage your clinical trials within the European Union and the UK can help you avoid costly delays and disruptions of your trial.
Clinigen Clinical Supplies Management made it a priority to look into how Brexit can affect your clinical trials from January 2021. We have positioned ourselves in such a way that we can successfully address any Brexit-related supply challenges. Our specialist European supply infrastructure allows continuity of service and supply to our clients, to minimise any Brexit-related impact on their clinical supply chains.
There is a lot of uncertainty surrounding the studies that started during the time period leading up to the trade deal deadline. 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 the United Kingdom, there may 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, we have access to our own depots within the UK, staffed with UK QPs. This allows us to store IMPs for clinical trials in the UK and provide optimum cost and time efficiency.
For the sourcing of comparator drugs, our relationships with local manufacturers provide maximum flexibility and the best supply routes to cover study demand for different sourcing scenarios.
Moreover, we’ve expanded operations of the exclusive On-Demand supply service with Accord Healthcare for comparator products beyond the UK into France. Through this arrangement, our clients will continue to access the Accord portfolio – both UK and EU packs of product – for their clinical trials worldwide.
Clinigen and Accord have been partners since 2012 in the delivery of oncology injectable and solid dose products. Products are held in large batch sizes on consignment ready for instant dispatch to new and existing clinical trials.
Clinigen can provide a fast, flexible and secure supply chain for the distribution of Accord’s European product portfolio to pharmaceutical manufacturers, contract research organizations (CROs), clinical trial contract packagers and other specialist service providers. Our ability to supply and distribute medicines across borders on an On-Demand basis and in a timely manner provides even more flexibility to our clients running their clinical trials anywhere in the world.
Many pharmaceutical companies running clinical trials in Europe work with contract research organizations (CROs) and contract manufacturing organizations (CMOs) based in the UK.
UK and UK-based CROs and CMOs are no longer part of the EU which can 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 can 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 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. Clinigen Clinical Supplies Management 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.
As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.