Update CEP Indian Pharmaceutical Association更新CEP印度制药协会.pptVIP

IPA-EDQM Mumbai 12/2007 ?2007 EDQM, Council of Europe Overview Scope and running the system The EDQM inspection programme Update and key figures Perspectives 2008 Scope and running the system The Certification procedure To show for a pharmaceutical substance: Suitability of the Ph. Eur. Monograph to control the quality of a substance Compliance with European regulatory requirements Created in 1994, scope enlarged Managed by EDQM Harmonisation and centralisation of work Legal background Directives 2001/83/EC and 2001/82/EC Ph Eur monographs are mandatory (specific and general) Need to demonstrate that a specific monograph is suitable to control the quality of the active substance Where there is a monograph in Ph Eur: CEP ‘deemed to replace the relevant section of the module’ (3.2.S) CEP holder must give assurance in writing to the applicant…no change since CEP granted by EDQM Prevention of TSE risks Demonstration of compliance preferably by a CEP Legal background (2) Note for guidance : ??Summary of requirements for active substances “(CHMP/QWP/297/97 rev. 1 EMEA/CVMP/1069/02): CEP ASMF Full information in Marketing Application Resolution AP-CSP(07) 1 of the Council of Europe: Procedural aspects Scope of the procedure Substances covered by a specific PhEur monograph: Active, excipients, herbal drugs / herbal preparations TSE risk products (SM, intermediates, reagents,..) Not applicable for biotechnological products, products from human tissues, semi-finished or finished products, substances not included in Ph. Eur Scope (2) Open to any manufacturer of active substance / expicient whatever the geographical origin Centralised evaluation Facilitates management of Marketing Applications CEP accepted in all EP countries (36) + others (eg Canada, Australia, Morocco, Tunisia, New Zealand..) Confidentiality respected CEP dossiers submitted directly by manufacturers No applicant part (≠ ASMF) Independently of any marketing application Archived in a specific restricted