New combination products and their legal authorization process – what to be prepared for?

Many of the most innovative medical instruments are actually combinations between drugs and tools that in general include a piece of medical instrument and a piece of drug.

device contract

Autor: Centrum Naturhouse
Źródło: Centrum Naturhouse

Combined solutions are frequently medical instruments covered or impregnated with a drug substance, for example a tube with an antimicrobial coating or a pharmaceutical coated stent. Other cases of ingenious solutions involve bone-containing cements consisting of antibiotics and spermicide-coated condoms.
In spite of the clinical advantages offered by combined instruments in the cure of some medical conditions, the procedure of administrative analysis and approval for combination products is frequently more complicated than that used for unbound products. For example, in the EU, the assessment on medical devices incorporating medicines should involve the opinion of a competent authority designated by the European Union member country. Combination product inventors are encouraged to develop a specific regulatory strategy, as fast as possible, in the process of developing new combination products. An effective regulatory strategy determines a comprehensive plan to go through the product approval procedure, coherent with the device contract and the inventor’s plans for its market launch. Inventors of combined products should also solicit the opinion of the competent authorities and independent third parties as concerns the documentation to be presented in support of the CE marking requirements.

These stages are adopted to make the authorization procedure as productive as possible and can help reduce the risk of unexpected and contractual delays that could protract or unable solution approval.

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