Ingenious combination products and their legal approval process – what to get prepared for?

By | 9 July 2021
Many of the most ingenious medical solutions are indeed combos between pharmaceuticals and instruments that usually include a piece of medical tool and a part of medication.

device contract

Autor: Centrum Naturhouse
Źródło: Centrum Naturhouse
Combined products are commonly medical tools coated or impregnated with a pharmaceutical substance, such as a catheter with an antimicrobial coating or a pharmaceutical coated stent. Other examples of ingenious solutions involve bone-containing cements consisting of antibiotics and spermicide-covered condoms.
Despite the clinical profits permitted by combined instruments in the treatment of various medical cases, the procedure of regulatory cross-examination and permission for combination products is usually more complex than that used for unbound solutions. For example, in the European Union, the evaluation on medical inventions incorporating pharmaceuticals should involve the opinion of a competent authority elected by the European Union member country. Combination product manufacturers are encouraged to develop a detailed regulatory strategy, as soon as possible, in the process of creating new combination products. An effective regulatory project has a detailed plan to go through the invention permission procedure, compatible with the device contract and the inventor’s plans for its market launch. Inventors of combined solutions should also request the opinion of the adequate authorities and autonomous third parties as concerns the documents to be presented in backing of the CE marking requirements.

These stages are adopted to make the authorization procedure as efficient as possible and can help reduce the risk of unforeseen and contractual setbacks that might prolong or unable solution approval.