Download BCEU INFORMATION SHEET - Biological Consulting Europe Ltd

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