CRED 8 Presentations

01/07/2024

Scientific advice (SA) at EMA

• The agency gives scientific advice by answering questions posed by companies. The advice is given in the light of the current scientific knowledge, based on the documentation provided by the company. It is not the role of the agency to substitute the industry's responsibility for the development of their products. • Scientific advice is prospective in nature. It focuses on development strategies rather than pre-evaluation of data to support a marketing authorisation application. • Scientific advice is not legally binding on the agency nor on the company with regard to any future marketing authorisation applications for the medicine concerned. Deviation should be justified. NB: figures have been published showing that asking SA will in most case lead to a successful MAA/MA

The Organisation for Professionals in Regulatory Affairs

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SNSA

SNSA is intendedto be used in situations wherean applicantwishes to obtain national scientific advice from more than one NCA at the same time. Currently phase 2 of the pilot is running until end 2024 The intentionof SNSA is to enhance the quality and consistencyof such advice. One NCA takes the lead (leading NCA), chosen by the applicant Meeting can be organisedincluding all NCAs participating in the SNSA For more information/application form/fees: See HMA website: Heads of Medicines Agencies: EU-Innovation Network (EU-IN) (hma.eu)

The Organisation for Professionals in Regulatory Affairs

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