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Regulatory Focus™ > News Articles > Scientific Advice Meetings for Centrally Registered Products (EMEA)

Scientific Advice Meetings for Centrally Registered Products (EMEA)

Posted 01 March 2009 | By Salma Michor, PhD, RAC

Scientific Advice is the process of seeking guidance from the European Medicines Agency (EMEA) during the drug development phase. Scientific Advice is designed to speed up the development and availability of high-quality, effective and acceptably safe medicines for the benefit of patients.1 The group responsible for giving scientific advice started its work as a consultation group in 1996 and as a formal Committee for Proprietary Medicinal Products (CPMP) working group in 2003.2 The new Regulation (EC) No. 726/2004 (Annex I) established the Scientific Advice Working Party (SAWP) as a standing working party of the Committee for Medicinal Products for Human Use (CHMP), with the sole purpose of providing scientific advice, particularly regarding the development of new therapies.3


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