An Approach of an Approval Strategy for a Regulatory-Driven Design of a Drug-Patch Combination Product according to the Current European Regulations

Introduction & background: Due to the Medical Device Regulation (MDR), Medtec industry was faced with major changes, including combination products. Qualification rules have been updated; new guidelines have been published. As a result, regulatory uncertainty hinders product innovations. A solid approval strategy is necessary. The product under analysis is a three component API-Carrier. Depending on the design, this combination can be used for oncological therapy or wound care. Based on the potential design options and the regulatory framework, an approval strategy was developed. Methods: An approach to find an approval strategy was developed. Over 270 data sources in the regulatory area were identified and considered to this case. Results: The European market was chosen as the initial target market. The preferred approval option is to place the unloaded carrier structure on the market as a medical device. The combined medicinal product will then undergo a simplified medicinal product approval. Here, the CE-certified carrier technology is referenced, and a notified body opinion is omitted. Discussion & limitations: The choice of target market is limited to the area of medical devices. Evidence, particularly regarding the potential mode of action, is outstanding. The acceptance by authorities remains to be seen. A quantifiable superiority of the chosen approach cannot be provided. Conclusion: Approval options were discussed, and a preferred one was selected. A conclusive line of argumentation was developed. The project will be pursued in the specified steps and efforts will be made to involve the authorities at an early stage.