Drug vs medical device clinical trial applications - TOPRA

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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.
November Issue 200627Table 4: “Active substance technical dossier” requirements (for a medical device)Technical dossier part Authorised active substance Unauthorised active substanceQuality Manufacturer statement Summary data on the pharmaceutical, chemical andbiological qualityNon-clinical and clinical Unaltered benefit/risk ratio Local pharmacokinetic and local effects data in particularAdditional SmPC –(Prepared from Order N°SANP0623370A, article 3)Abridged technical dossierIn certain circumstances (see Table 5 and Table 6), an abridged technical dossier for IMPs and medical devices can be submitted to the AFSSAPS.The general principle is that whenever the IMP or the medical device is already “known” to the AFSSAPS or another EU competent authority,the submission of an abridged technical dossier is permitted.Table 5: Simplified technical dossier for IMPs (simplified IMPD)CircumstancesSimplified IMPD contentQuality Data Non-clinical Data Clinical DataThe IMP has a MA in any EU Member State, USA or Japan, or isauthorised for a compassionate use in France, and is used in the trial:– within the conditions of the SmPC SmPC SmPC SmPC– outside the conditions of the SmPC SmPC Yes YesThe IMP has no MA in any EU Member State but:– another pharmaceutical form or strength of the IMP has a MA inany EU Member State and the IMP is supplied by the MAH– the drug substance is part of a product with a MarketingAuthorisation in a MS and is supplied from the same manufacturerSmPC Yes YesSmPC Yes YesThe sponsor has already submitted a CTA for this IMP to theAFSSAPS and– new data are available since CTA New Data New Data New Data– the IMP is used in the trial outside the conditions stated in theprevious CTANo Yes YesThe IMPD was submitted as part of a previous CTA submitted by athird party who authorised the sponsor to refer to the previousCTA and– new data are available since CTA New Data New Data New Data– the IMP is used in the trial outside the conditions stated in theprevious CTANo Yes YesThe IMP is a placebo P+A No NoBut if the excipients are identical to the IMP and if it is not a sterile No No NoformIMP: Investigational Medicinal Product; IMPD: Investigational Medicinal Product Dossier; MA: Marketing Authorisation; MAH: Marketing Authorisation Holder;CTA: Clinical Trial Application. (Prepared from Order N°SANP0622223A, article 4)www.topra.org
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