Expert reports, marketing authorisation applications

The experts reports joining the application for authorisation to introduce a drug in the market must contain a reasoned explanation of the sufficiently innovative character claimed for the drug. 

Once the clinical and safely evaluation studies for a new medicinal product have shown it to be safe, effective and of acceptable quality, the pharmaceutical company will usually want to submit a Marketing Authorisation Application (MAA) or New Drug Application (NDA) to the regulatory authorities. The chemistry, manufacturing and controls (CMC) section will form a major part of the application. For an MAA in Europe, a development pharmaceutics section is required to describe how the product was developed, and to explain the rationale for the selection of the formulation, pack, manufacturing process and specifications. Also required for Europe are expert reports for each of the pharmaceutical, safety and clinical parts of the application. These have to be written by experienced scientists nominated by the pharmaceutical company who have to critically appraise the development programme for the product. The pharmaceutical expert must acknowledge the acceptability of the CMC part of the application. 

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... 

Theoretically, the time from application to authorisation in the RMS should be less than 210 days. In fact, according to recent figures, it may vary from about 150 to almost 400 days for novel products. This is not surprising as the complexity of the data submitted can vary enormously and applicants take time to reply to questions posed. In the case of products which have been on the market of a particular MS for several years, new developments in science or in clinical practice may have taken place and a review of the existing and new data is appropriate, together with a re-evaluation of the risk benefit balance. This review should lead to updated expert reports and to an updated assessment report in the MS and is known as updating the dossier. ... 

The application format is to be harmonised with the EU Notice to Applicants (Expert Reports will also be requested). The particulars cind documents accompanying an application for marketing authorisation (MA) must be presented in four parts ... 

Application for marketing authorisation using either the centralised or the mutual recognition procedure has to be submitted in four highly structured parts - I, II, III and IV. Volume 2B of the Rules Governing Medicinal Products gives a detailed breakdown of the structure of each part of the dossier, including the three mandatory expert reports. 

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