Formulation and Quality – Chemical
Drugs and devices are regulated differently for very good reasons, so what happens when they are combined - what data should be generated, which regulatory authorities will review it and how should it be submitted? There are many challenges for both industry and regulators to address - and as medical technologies advance, more products are being developed that raise difficult questions. The US FDA Office of Combination Products was established in 2002 to address some of these challenges and has been working hard to improve cross-agency consultation efficiencies, as well as produce more guidance on requirements. What about other regions? The new EU Medical Device Regulation came into effect in 2017 amending the medicines legislation to place greater emphasis on review of safety and performance of devices incorporated into drug products. This will involve a new consultation procedure with third party 'notified bodies' from May 2020, but there is no guidance yet on how this will work in practice.
This presentation will explain the regulatory situation and recent developments for combination products in Europe and discuss industry collaboration work being led by the European Biopharmaceutical Enterprises (EBE) Biomanufacturing group - reflection papers available on the EBE website https://www.ebe-biopharma.eu/media-centre/position-papers/. Outcomes of the October TOPRA Annual Symposium joint Human Medicines/Medical Devices session involving The European Medicines Agency, EMA, and industry representatives will also be shared 'Medicinal products with integral medical devices – bringing two worlds together' https://www.toprasymposium.org/.