Affiliations: Celgene EU Regulatory Affairs, Boudry, Switzerland.
E-mail: [email protected]
Abstract: Scientific advice constitutes an important part of the development
strategy as it can increase the likelihood of regulatory success. For this
reason, its timing has to be carefully planned. There are essentially two
routes which can be followed to get scientific advice in the EU: a "national advice", which is a decentralised procedure
and involves meeting with one national authority; a "scientific advice" at the CHMP level, which is centralised, called protocol assistance for
designated orphan drugs. This is a pan-European advice, which is adopted by the
CHMP based on the recommedations of the SAWP.
Keywords: Scientific advice, centralised procedure, national scientific advice, CHMP, SAWP