1. Experience from a Generic Dossier Dr. Roger Bolten, 16 th March 2011

2. ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 2 Introduction and Content ► Facts on eCTD submissions in Switzerland ► Aim of Generic Companies ► Introduction in Sources of Generic Dossiers ► Challenge in eCTD ► Possible solutions

3. Facts Since 1.1.2010 eCTD submission are allowed: eCTD submissions January 2010 to February 15th 2011 ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 3 Initial Marketing Authorisations:  Generika: Generics  NAS: New Active Substance  BWS: Known Active Substance  NA div.: consists of: NKO (New combination), NDO (New Dosage Strength), NGF (New Dosage Form), NDE (New Dosage Recommendation), IE (New Indication)

4. ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 4 Facts ► Question: Why do the companies not submit Generic eCTDs ? Why is the paper submission still so popular ?

5. Aim of Generic Companies ► T2M: Time to market –Patent: First day of patent expiry –Data protection: To be the first ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 5

6. Sources of Generic Dossiers ► SDD Dossiers (Self Directed Development) –Own control over documents –Filing directly in the corresponding tools  Preparation of eCTD submissions possible –Requirement: Availability of an eCTD tool ► Licensing-In –«get dossier» from external developer –Reliance on the documentation you get (pdf-files, NEES, eCTD) ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 6

7. Challenges in eCTD ► Companies with eCTD tool (filing locally): –SDD: Recommended eCTD submission –Licensing-In: Depending on dossier status –eCTD: proof on validity of Modules 2-5 –NEES, pdf-files: work and time intensiv to create eCTD Problems: access to the files, time, costs, Swissmedic specific requirements which differs to EU-File (Modules 2-5) Easier: paper submission ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 7

8. Challenges in eCTD ► Companies with eCTD tool (filing in motherhouse, not locally): –Swiss Module 1 –File compilation (back and forth) –Time consuming –Hyperlinking Module (e.g form BEQ) –Different Validation tools  Decision “no go” for Switzerland ► Companies with a self developed tool for eCTD –To expensive to program the Swiss specific module 1 ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 8

9. Challenges in eCTD ► Companies without eCTD tool: –eCTD tools are expensive –smaller companies, only local –bigger companies, global approach –External solution –Consultant: expensive approach Problem: Gap between requirements and costs Solution: Paper submission ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 9

10. Challenges in eCTD ► T2M: do not lose time –Technical problems during filing the eCTD –Did not pass technical validation at Swissmedic –Missing experience in handling eCTD’s at time being  At the moment paper submission are easier and faster to submit than electronic submission ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 10

11. Possible Solutions ► Electronic submission will be more and more an EU requirement –Licensor offers more and more real eCTD’s –Offer of cheaper «low budget» eCTD tools –Electronic archiving of documents more and more a requirement –Growing «know-how» to handle eCTD easier and faster ► Generic Dossier► Dr. Roger Bolten► 16. March 2011► Seite 11

12. Thank you for your attention