1 / 9

CTD: regulatory documents

IMPLEMENTATION 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-. CTD: regulatory documents . Europe :

xue
Download Presentation

CTD: regulatory documents

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. IMPLEMENTATION STATUS OF THE CTD IN THE OTHER ICH-REGIONS:Europe, Japan and Canada Christelle AnquezOffice of International ProgramsUS Food and Drug Administration-Public meeting, January 21, 2003-

  2. 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)

  3. 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

  4. Timeframe Voluntary submission: July 2001-July 2003 Then… Europe and Japan: mandatory from July 2003 Canada: Highly recommended

  5. Transitional arrangements EU: ”Mixed format”allowed 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)

  6. Question & Answers EU: specific regulatory/administrative questions http://pharmacos.eudra.org/F2/eudralex/vol-2/B/ctdqa_au2002.pdf Japan: Q&As document on the organization of application dossier appended to the New Pharmaceuticals application for Approval -oct. 2001- Under revision Canada: regional Q&A will be included in Canadian General Considerations guidances

  7. 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)

  8. 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

  9. 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.org/F2/eudralex/vol-2/B/part1a_jul02.doc • Japan: http://www.nihs.go.jp/dig/ich/m4index-e.html • Canada: CTD implementation package • www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/guide_ctd.html

More Related