This week in London, Medicines for Europe gathers regulators and industry leaders to discuss the future of regulation of generic, biosimilar and value added medicines industries.
Our industries, which supply 67% of Europe’s medicines, face an unprecedented set of regulatory challenges in the year ahead. With less than two months to adapt to the UK withdrawal from the European Union, we renew our calls for a clear contingency plan. Pragmatic solutions are needed to avoid medicine supply disruptions as companies finalise the process of separating UK and EU activities. New regulatory requirements including the Falsified Medicines Directive and extended requirements for environmental risk assessment need to be implemented thoughtfully in partnership between industry and regulatory authorities. This will help avoid disproportionate impacts on essential medicines that the majority of European patients rely on.
The EU must seize the opportunity to lead in international regulatory cooperation for the global development of complex medicines. Similarly, the EU’s ability to align with partners such as the US Food and Drug Administration (FDA) on Good Manufacturing Practice (GMP) mutual recognition offers the possibility to strengthen the oversight of global manufacturing supply chains. Digital tools like electronic patient information leaflets (‘e-leaflet’) need to be leveraged to improve the flow of information to patients and eliminate the vast complexity of updating paper leaflets in over 20 languages across the EU.
Marc Alexander Mahl, Medicines for Europe President commented: “The dialogue between industry and regulators to optimise the regulation of pharmaceuticals is an essential part of access to medicines. We need to take material steps forward to grasp the opportunities in areas like e-leaflets and global development while carefully managing disrupters such as Brexit. ”