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