1. IMPLEMENTATION STATUS OF THE CTD IN THE OTHER ICH-REGIONS: Europe, Japan and Canada Christelle Anquez Office of International Programs, OC Food and Drug Administration -Public meeting, May 8, 2001-

2. 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

3. 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

4. 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...

5. 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)

6. 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

7. 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?

8. 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