IMPLEMENTATION STATUS OF THE CTD IN THE OTHER ICHREGIONS: Europe, Japan and Canada Christelle Anquez

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IMPLEMENTATION STATUS OF THE CTD IN THE OTHER
ICH-REGIONSEurope, Japan and Canada
Christelle AnquezOffice of International
ProgramsUS Food and Drug Administration-Public
meeting, January 21, 2003-
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CTD regulatory documents

• Europe
• Vol.2 , Notice to Applicant Vol. 2B Presentation
  and Content of the Dossier -May 2002
• New templates for Assessment Report for
  Centralized procedure
• Revision of legislation to reflect CTD update
  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 templates -September 2001
• Data guidelines (e.g preparation of
  bioequivalence data in CTD formatted submissions)

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Scope
Europe All product type (new chemical entities,
radiopharmaceuticals, vaccines, herbals, etc.)
Japan NCEs and New Biologics, New indication,
New dosage forms/dose, New route of
administration Generics and OTC are not
covered Canada NCEs, new biologics, new
indications, new dosage forms, new routes of
administration, generics and OTCs then will
extend to all other biologics and
radiopharmaceuticals
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Timeframe
Voluntary submission July 2001-July
2003 Then Europe and Japan mandatory from
July 2003 Canada Highly recommended
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Transitional arrangements
EU Mixed formatallowed i.e part CTD and part
old EU format no mixing within modules module
1 must be provided module 2 either expert report
or overview/summary specific guidance for
location of bio-availability date and (non)-GMO
Environmental Risk Assessment Data Japan
Acceptance of application using a combination of
the CTD and non-CTD formats providing that the
format used within a module is the same Canada
Idem as in Japan (program areas and guidance
available)
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Question Answers
EU specific regulatory/administrative questions
http//pharmacos.eudra.org/F2/eudralex/vol-2/B/ct
dqa_au2002.pdf Japan QAs document on the
organization of application dossier appended to
the New Pharmaceuticals application for Approval
-oct. 2001- Under revision Canada regional QA
will be included in Canadian General
Considerations guidances
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Training/Workshops

• EU
• Training for assessors organized by
  EMEA/Commission in June-July 2001 (CTD Q, S, E),
  March 2002 (navigator tool for the eCTD),
  November 2002
• Japan
• Internal explanatory meeting for reviewers in
  October 2002
• Workshop on CTD-Q for industries (August 2002)
• using the CTD-Q mock up developed by Regulatory
  and industry experts
• Canada Training at the end of February for
  industry in Montreal and Toronto
• Survey (reviewers and then industry)

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CTD Submissions received

• EU
• Centralized procedure (EU level)
• 7 new submissions in full CTD format and 3 new
  application in mixed format
• 5 supplemental applications
• 10 expected
• Decentralized procedure (EU member states level)
  under evaluation
• Japan 4 new submissions
• Canada 9 new submissions, 8 supplemental and 10
  abbreviated

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Website addresses

• EU pharmacos.eudra.org/F2/pharmacos/docs.htm
• Eudralex documents Vol 2B
• Download tables from module 1.2, 2.6 and 2.7
• Application form, part IA http//pharmacos.eudra.o
  rg/F2/eudralex/vol-2/B/part1a_jul02.doc
• Japan http//www.nihs.go.jp/dig/ich/m4index-e.htm
  l
• Canada CTD implementation package
• www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/guide_c
  td.html