1. Swissmedic Swiss Agency for Therapeutic Products Hallerstrasse 7 CH-3000 Bern www.swissmedic.ch From Step 2 to Step 3 of the eCTD Introduction 2nd Follow-up Information Meeting with Workshops – Step 3 Dr. Claudia Zerobin Kleist 16th March 2011

2. 2 Overview 1.SIMES Step 3: Core Areas 2.Staggered approach for eCTD introduction 3.Impact on business 4.eCTD submissions since January 2010 5.Experiences 6.Conclusions

3. 3 SIMES Step 3: Core Areas (I) Further development and finalisation of the draft guidance  Applications according to paragraph 13 TPA (incl. pilot phase)  PSUR (incl. pilot applications) Update of guidance documents (1/2)  Guidance for Industry on Providing Regulatory Information in eCTD Format  v1.2  Questions & Answers of Swissmedic’s eCTD Introduction  v1.3 3

4. 4 SIMES Step 3: Core Areas (II) Update of guidance documents (2/2)  Immediate adaptation of the eCTD specification for step 3 arose not to be mandatory  Swiss Module 1 Specification for eCTD and Swiss Validation Criteria remain stable  Adaptation of the internal guidance documents for step 3 Communication and training  Follow-up information event for stakeholders (August 2010 and March 2011)  Internal training (January 2011) 4

5. 5 SIMES Step 3: Core Areas (III) Not part of step 3  Update of the IT tools (via release planning within the support organisation) Principles  Carry on established principles and ways of working of steps 1 / 2  Project setup (working groups):  WG Internal Regulations  WG Specification & Guidance  WG Communication & Training  Working with external stakeholders continued  No surprises for applicants 5

6. Complete Life Cycle Staggered approach for eCTD introduction (I) 8.Temporary Authorisation 9.Notification of sample packs

7. Staggered approach for eCTD introduction (II) Application types not (yet) possible in eCTD format  Application for Fast Track Procedure  Application for Orphan Drug  Notification procedure for complementary medicine  Application for Scientific Advice  Recognition of the product monograph  Veterinary products  Medical Devices  Clinical Trial Applications

8. Impact on business (I) Significant impact in business processes  Paper-related processes remain, but electronic processes were established in addition (parallel processes) Significant impacts for Swissmedic staff (1/2)  Facility Management (Document Management and Archiving)  Working with electronic submissions is a new task and requires new skills (technical validation, administration and electronic handling)

9. Impact on business (II) Significant impacts for Swissmedic staff (2/2)  Sector Marketing Authorisation  In the absence of a document management system the electronic marketing authorisation process has to be managed as well as possible with basic IT tools (standardised e-mails, dedicated mailboxes, electronic forms)

10. 10 eCTD submissions Jan. 10 – Feb. 15, 11 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)  ̴ 15% (95 out of 645) of all initial marketing authorisation applications are electronic-only submissions  ̴ 60% of NAS applications are electronic-only submissions

11. 11 Variations since July 2010 Variations (submission possible since July 1, 2010)  25 variations have been submitted as electronic-only submissions 11 variations requiring authorisation including scientific review 1 variation requiring authorisation w/o scientific review 8 variations requiring authorisation of the product information (SmPC, patient information) 5 variations requiring a notification procedure 11

12. 12 eCTD submissions Jan. 10 – Feb. 15, 11 eCTD sequences  A total number of around 161 eCTD sequences have been entered into the Swissmedic eCTD review system Companies  A number of 44 pharmaceutical companies have submitted esubmissions to Swissmedic 12

13. 13 Experiences (I) Collaboration with industry  The guidance documents for industry were prepared on time and in a efficient way.  Acceptability of specification and guidelines was high on industry’s side  Active involvement of SGCI in communicating the solution lead to confidence building 13

14. 14 Experiences (II) Adaptation of the Swissmedic-internal processes concerned  took longer than planned  need for intense discussions of changes in the processes and responsibilities  Advantage: solution has been fit for practice from the beginning and lead to a higher degree of acceptability by the persons concerned  eCTD leads to need for associates with modified competencies  Allocation of the new tasks to a subset of associates and intensification of trainings 14

15. 15 Experiences (III) Internal Communication  Internal communication of the solution on the department level showed to be important for awareness rising with associates concerning the changes and increased the commitment of the project team members External Communication  Information meetings help to promote electronic submissions with applicants 15

16. 16 Experiences (IV) Training  Trainings adapted to the role of the associate at the time of introduction of step 1 lead to good adoption of esubmissions within Swissmedic Faith in a productive eCTD solution on industry’s side  None of the electronic submissions was delayed so far due to the technical proceeding  Rapid reaction (within 24 hours) by a single point of access (esubmission@swissmedic.ch)(esubmission@swissmedic.ch 16

17. 17 Conclusions  Swissmedic is ready to receive esubmissions for all submission eligible for eCTD  Swissmedic receives an increasing number of esubmissions  The approach of working with stakeholders was a success  Continuous learning and improving remains a challenge  eCTD will continue to challenge

18. 18 Thank you for your attention Dr. Claudia Zerobin Kleist Business Project Manager SIMES Step 3 Swissmedic claudia.zerobin@swissmedic.ch eCTD