Post on 14-Dec-2015
IMPLEMENTATION STATUS OF THE CTD IN THE OTHER
ICH-REGIONS:Europe, Japan and Canada
Christelle AnquezOffice of International Programs, OC
Food and Drug Administration
-Public meeting, May 8, 2001-
IMPLEMENTATION STATUS OF THE CTD IN THE OTHER
ICH-REGIONS:Europe, Japan and Canada
Christelle AnquezOffice of International Programs, OC
Food and Drug Administration
-Public meeting, May 8, 2001-
CTD implementation document
• Europe: “Presentation and Content of the dossier CTD”
• Japan: “Notifications on General Principle of CTD implementation”
• Canada: “Preparation of Drug Submissions in the CTD format”
All 3 drafts have been posted/published in April
Deadline for comments in May
CTD implementation document:Content
For all 3 regions: • Scope• Timeframe of implementation• Content of Module I• Relationship between the previous format
and the CTD format• Regulatory requirements
Scope • Europe: “intended to be applicable to all
categories of medicinal products”• Japan: NCEs and New Biologics, New
indication, New dosage forms/dose, New route of administration
Generics and OTC are not covered• Canada: NDS (NCEs, Biotech Products) then
abbreviated NDS, Supplemental Applications...
Timeframe Voluntary submission:
All 3 regions: July 2001
Then...• Europe: mandatory in July 2002 with some
flexibility• Japan: mandatory in July 2003
• Canada: no date yet fixed for mandatory use. Working assumption: July 2002 (NCEs and Biotech)
Sharing of information • The 3 regions: Telecons on a regular basis between
regulators• Europe: DIA workshop on the CTD in Paris in April
Some information on the EC website • Japan: Open forum with the industry in February• Canada: 2 meetings with the industry in January
(Montreal, Ottawa)
Workshop with the stakeholders in April
CTD implementation on Health Canada website with opportunity to ask questions
To be determined...• Europe: Placement of the DMF ?
Environmental assessment ? TSE provisions? Region-specific requirements?
Cross-referencing between the old dossier and the new CTD format possible ?
• Japan: Module V and the list of patients ?
• Canada: Placement of Environmental assessment of New Substances? Cross-referencing?
Training
• Europe: 3 Assessor training sessions, one each for Quality, Safety, Efficacy in June-July in London
• Japan: Training sessions with industry in June in Tokyo and Osaka
• Canada: Joint industry/reviewer training session is planned