CESP欧洲通用提交平台 英文.pdfVIP

CESP Demonstration What is the Common European Submission Platform (CESP) ? CESP is an online delivery system , capable of accepting information from stakeholders through one portal and distributing it to one or more agencies. Features: • A simple and secure mechanism for exchange of information between stakeholders and agencies. • Currently provides a delivery system for: – CAP/ MRP / DCP / National submissions for both human and veterinary products. – Clinical Trial Information – Scientific Establishments • Accepts all submission types and includes mechanisms to handle resubmitting of updated information. • Not dependent on submission standards, i.e. will accept eAF, eCTD , NeeS , vNeeS. • One-way, from Industry to Regulator, with simple notification systems • Can manage files and folders of varying sizes • Eliminates the effort for handling CD/DVD submissions Benefits of CESP  Reduces manual processing of submissions for agencies and stakeholders.  Low cost solution for industry.  Multi purpose delivery system, can be used for any type of digital information transfer.  Simple , fast , efficient delivery system for information.  Single submission platform to multiple agencies.  Allows faster submission updates/ responses to agency information requests. Participating Agencies • Austria (AGES) • Ireland (IMB) • Belgium (FAGG) • Italy (AIFA) • Croatia (HALMED) • Latvia (State Agency for Medicines) • Cyprus (MOH) • Lithuania (VVKT) • Czech Republic (UKZBL) • Luxembourg ( Ministere de la Sante) • De