title: [Experimental testing of centrally authorised medicinal products. The CAP programme].
abstract: In addition to marketing authorisation, inspection and pharmacovigilance the experimental testing within the CAP programme provides another important instrument of assessing and testing centrally authorised medicinal products. Coordinated activities in European member states and institutions--including planning, sampling, lab testing, reporting and assessment of results--allow us to establish an effective quality control system for this group of innovative medicinal products. By means of using existing networks and national structures, unnecessary parallel sampling and testing can be avoided, and limited resources can be used in a better way. The CAP programme is an independent test and surveillance programme, which demonstrates the high quality of centrally authorised medicinal products in the EU/EEA. That way, it strengthens the confidence of patients and the public in these innovative medicinal products. Furthermore, it enables OMCLs to gain experience with new sensitive analytical methods, which can also be used in other areas, for example for the identification of counterfeits or the assessment of biosimilars and generics.
authors.affiliation: Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland, siegfried.giess@pei.de.
authors.forename: S
authors.initials: S
authors.lastname: Giess
mesh_terms: D004341:Drug Evaluation / Q000331:legislation & jurisprudence* / Q000592:standards*; D005060:Europe; D005062:European Union / Q000458:organization & administration*; D006078:Government Programs / Q000458:organization & administration*; D033161:Government Regulation; D007753:Laboratories / Q000458:organization & administration* / Q000592:standards; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations