Patient information dossier

An application for a marketing authorisation must be accompanied, among other items, by specified pharmaceutical, preclinical and clinical particulars and documents (the dossier ). Three important summary documents in the dossier are the SPC, a Package or Patient Information Leaflet (PIL), and the sales presentation of the product (label). The SPC has a formally prescribed structure (Box 17.1), and forms the basis for authorised chnical prescribing of the medicinal product concerned. 

Part I was a summary of the information presented in the whole dossier and included the application forms and administrative particulars on fees, various declarations and the t)rpe of application as well as particulars of the marketing authorisation (lA), proposed SPC (IBl), proposals for packaging, labels and package or patient information leaflets (IB2), and any SPCs already approved in the Member State(s) for the particular product (IB3). Also included were separate Expert Reports on chemical and pharmaceutical (ICl), pharmacotoxicological (preclinical) (IC2), and chnical documentations (IC3), as... 

The Medicines Agency publishes a summary of the authorisation dossiers for all new medicines inspired by the European Product Assessment Report (EPAR) of the EMEA. It organises information on meetings with representatives of various patient organisations and users of the medicines concerning the safety problems of the healthcare products. 

A very important cultural difference between Europe and the USA, that impacts upon drug development, is indirectly expressed at the stage when the regulatory authority examines the final submitted dossier. In the USA, the FDA adopts a bottom-up stance, in which it looks at the basic raw data and sees what conclusions can be drawn from it, using its own criteria for analysis and interpretation. In Europe the authorities adopt an attitude diametrically opposed to that of the FDA, by looking at the conclusions of all the studies, as manifested in the proposed labelling, patient leaflets, and summary of product information, and examining to what extent the data presented justify these conclusions. In Europe, considerable importance is placed on the role of independent experts, whose critical reports on the various sections of the dossier provide a sort... 

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