Execution STATUS OF THE CTD IN THE OTHER ICH-REGIONS: Europe, Japan and Canada Christelle Anquez Office of Inter

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2. . CTD: administrative reports . Europe: Vol.2 , Notice to Applicant Vol. 2B Presentation and Content of the Dossier - May 2002New formats for Assessment Report for Centralized procedureRevision of enactment to reflect CTD: upgrade Annex I to Dir. 2001/83/EC Japan:

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Execution STATUS OF THE CTD IN THE OTHER ICH-REGIONS: Europe, Japan and Canada Christelle Anquez Office of International Programs US Food and Drug Administration - Public meeting, January 21, 2003-

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CTD: administrative records Europe : Vol.2 , Notice to Applicant Vol. 2B Presentation and Content of the Dossier - May 2002 New formats for Assessment Report for Centralized method Revision of enactment to reflect CTD: refresh Annex I to Dir. 2001/83/EC Japan : "On Organization of Application Dossier Appended to New Pharmaceuticals Application (NDA) for Approval" - June 2001 Canada : Preparation of Drug Submissions in the CTD Format" & layouts - September 2001 Data rules (e.g readiness of bioequivalence information in CTD designed entries)

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Scope Europe : All item sort (new substance elements, radiopharmaceuticals, immunizations, herbals, and so on.) Japan : NCEs and New Biologics, New sign, New measurement frames/dosage, New course of organization Generics and OTC are not secured Canada : NCEs, new biologics, new signs, new dose shapes, new courses of organization, generics and OTCs then will stretch out to all different biologics and radiopharmaceuticals

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Timeframe Voluntary accommodation: July 2001-July 2003 Then… Europe and Japan : obligatory from July 2003 Canada: Highly prescribed

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Transitional plans EU : "Blended format"allowed i.e part CTD and part "old" EU arrange; no blending inside modules module 1 must be given module 2: either master report or diagram/synopsis particular direction for area of bio-accessibility date and (non)- GMO Environmental Risk Assessment Data Japan : Acceptance of use utilizing a combination of the CTD and non-CTD groups giving that the configuration utilized inside a module is a similar Canada : Idem as in Japan (program territories and direction accessible)

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Question & Answers EU : particular administrative/regulatory inquiries http://pharmacos.eudra.org/F2/eudralex/vol-2/B/ctdqa_au2002.pdf Japan : Q&As archive on the association of utilization dossier added to the New Pharmaceuticals application for Approval - oct. 2001-Under update Canada : territorial Q&A will be incorporated into Canadian General Considerations directions

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Training/Workshops EU : Training for assessors composed by EMEA/Commission in June-July 2001 (CTD Q, S, E), March 2002 (pilot device for the eCTD), November 2002 Japan : Internal logical meeting for analysts in October 2002 Workshop on CTD-Q for ventures (August 2002) utilizing the CTD-Q ridicule up created by Regulatory and industry specialists Canada : Training toward the finish of February for industry in Montreal and Toronto Survey (commentators and after that industry)

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CTD: Submissions got EU : Centralized strategy (EU level) 7 new entries in full CTD organization and 3 new application in blended arrangement; 5 supplemental applications; 10 expected Decentralized technique (EU part states level): under assessment Japan : 4 new entries Canada : 9 new entries, 8 supplemental and 10 condensed

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Website addresses EU : pharmacos.eudra.org/F2/pharmacos/docs.htm Eudralex reports Vol 2B Download tables from module 1.2, 2.6 and 2.7 Application frame, part IA http://pharmacos.eudra.org/F2/eudralex/vol-2/B/part1a_jul02.doc Japan : http://www.nihs.go.jp/burrow/ich/m4index-e.html Canada : CTD usage bundle www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/guide_ctd.html