Innovative combination products and their legal authorization process – what to be ready for?

Many of the most inventive medical solutions are actually combinations between drugs and tools that generally include a component of medical device and a piece of medication.

device contract

Autor: Centrum Naturhouse
Źródło: Centrum Naturhouse
Combined solutions are commonly medical instruments coated or impregnated with a drug substance, such as a catheter with an antimicrobial coating or a pharmaceutical covered stent. Other illustrations of innovative products involve bone-containing cements consisting of antibiotics and spermicide-covered contraceptives.
In spite of the medical benefits allowed by combined devices in the cure of some medical cases, the procedure of administrative analysis and permission for combination products is usually more intricate than that applied to unbound solutions. For example, in the EU, the evaluation on medical inventions incorporating drugs should involve the judgement of an adequate authority nominated by the European Union member state. Innovative product inventors are encouraged to estaplish a precise regulatory project, as fast as possible, in the procedure of creating new combination products. An effective regulatory strategy contains a detailed plan to pass through the product permission procedure, coherent with the device contract and the manufacturer’s plans for its market introduction. Manufacturers of combined devices should also demand the judgement of the competent authorities and independent third parties as regards the documents to be presented in backing of the CE marking requirements.

These steps are used to make the approval procedure as efficient as possible and can support reducing the risk of sudden and contractual setbacks that could extend or compromise product authorization.