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Biological Consulting Europe Ltd Wallace Building Roslin BioCentre ROSLIN Midlothian EH25 9PP United Kingdom BCEU BCEU INFORMATION SHEET P: +44 (0) 131 440 6480 F: +44 (0) 131 440 6486 www.bioconsulteurope.com Scientific Advice Procedures in Europe for Human Pharmaceuticals Obtaining scientific advice from the regulatory agencies is a key part of the overall development programme for human pharmaceuticals. Ongoing interaction with the agencies from the early stages of development through to the marketing authorisation stage increases the probability of a successful outcome. In Europe, two routes are available for seeking scientific advice: the central route which involves submitting a request to the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP); the national route where requests are submitted to the regulatory agency of one or more individual Member States of the European Union. Scientific advice requests are categorised according to the ICH/CTD definitions and can be made for any, or all, of these categories: quality (chemistry, pharmacy and manufacturing); non-clinical (toxicology and pharmacology); clinical (safety and efficacy). Scientific advice procedures in Europe typically require the payment of fees which vary dependent a number of factors. For advice obtained by the central route, the fees are set by the European Medicines Agency (EMA). For companies with Small and Medium sized Enterprise (SME)* status, access to the scientific advice process is facilitated by a 90% fee reduction. In the case of products with Orphan Designation* there is a 100% reduction for those companies with SME status. For companies without SME status the fee reduction for Orphan Products is 40%. The selection of a national and/or centralised scientific advice procedure should be based on considerations such as stage of development, therapeutic class and intended marketing strategy. In some cases it is valuable to obtain advice from national agencies prior to seeking centralised scientific advice from the SAWP of the CHMP. BCEU has extensive experience in assisting companies seeking scientific advice, both centrally and on a national basis, and supporting these companies with their subsequent development programmes. *The Orphan Designation and SME processes are described in separate BCEU Information Sheets. V2.3 Jul 2013 Consultants to the Biopharmaceutical Industry Biological Consulting Europe Ltd registered in Scotland, number SC370519, registered office Quartermile Two, 2 Lister Square, Edinburgh EH3 9GL
