Drug vs medical device clinical trial applications - TOPRA

26RegulatoryRapporteurPart 3 – Technical dossierThe content of the technical dossier for an IMP (so-called IMP dossier,“IMPD”) or a medical device should include different sectionssummarising the quality, the non-clinical and the clinical data (whererelevant) and include a benefit/risk assessment.Obviously, the content of the quality, non-clinical and clinical sectionswill differ significantly between both product types and thereforecannot be compared. Nonetheless, guidance on the content of thetechnical dossier of specific products has been released and is brieflysummarized here.Case of medical devices containing an active substance“Where the biomedical research implies the use of a medical devicecontaining an active substance, which – when used separately – islikely to be considered as a medicinal product, the technical dossiershould be completed by information regarding this active substance”.Pursuant to this requirement, the technical dossier should includequality, non-clinical and clinical data – in particular local pharmacokineticand local effects data – on the active substance used, completed by ascientific rationale justifying its addition to the medical device.It is interesting to note that, where the active substance has alreadybeen authorised as part of a medicinal product in the EU, the qualitysection related to this substance may be limited to the SmPCtogether with a statement from its manufacturer specifying that it isstrictly identical to the one contained in the authorised medicinalproduct – and described in the quality part of the approved MarketingAuthorisation dossier. In that case, the non-clinical and clinical datashould demonstrate that the efficacy/safety ratio remains unalteredwhen compared to the usual utilisation of the medicinal product.On the contrary, when the medical device contains an “unauthorisedactive substance”, the data to be provided on the active substance aresimilar to the ones which need to be included in the so-called “full IMPD”.Table 4 details the data to be provided as part of each of the threesections of the “active substance technical dossier” depending on itsauthorisation status.