(Co) Rapporteur - TOPRA

Industry experience with a recently approved
application where Hungary was
(Co) Rapporteur
Sibylle Grub
Novartis Pharma AG

Registration of a New Medical Entity
>„Rasilez“, „Enviage“, „Riprazo“, „Sprimeo“, „Tekturna“
active substance Aliskiren for the treatment of hypertension
under the Centralized Procedure
Submission - Sep 2006; Com Dec - Aug 2007
Rapporteur:
Co-Rapporteur:
Prof Guiseppe Nistico /Italy
Prof Janos Borvendég/ Hungary
- Discussion of future subsequent plans (FDCs)
- Discussion of life cycle management plans for Rasilez
- Portfolio meetings

Centralized Procedure
Day 0
Day 80
Day 120
(Clock stop ->
std 2m
Submission of application to EMEA
Dossier validated; review starts by Rapporteur/Co-rapporteur
Co-Rapporteur’s Assessment Report
Consolidated List of Questions from CHMP
Submission of Response to questions
05 Sep 2006
27 Sep
12 Dec
25 Jan
14 Mar
Day 121
Review of responses by Rapporteurs and CHMP
25 Mar
Day 150
Joint AR
30 April
Day 180
Day 181
CHMP “List of questions” or “oral hearing” invitation
Response to questions by applicant
+
24 May
21 June
Day 210
CHMP opinion
19 Jul
Day (277) 272
Commission Decision
+
1 month clock stop
22 Aug

Assessment team Hungary
Quality
Annamária Tamás
Timea Rajna
Julia Németh Palotás
Erzsébet Bozsik
Hilda Köszegi-Szalai
Non-clinical
Ilona Hermann
Ágnes Gyurasics
Sándor Elek
László Tóthfalusi (Ext: Assoc Professor Dept Pharmacolodynamics / SOTE)
Clinical
János Borvendég
Péter Gergely (Ext: Director SOTE, Central Laboratory of Immunology)
Sándor Elek
Lázló Tóthfalusi (Ext: Assoc Professor Dept Pharmacolodynamics / SOTE)

Activities in which the Co-Rapporteur
(& the Assessment team) was involved
Preauthorization Activities:
- Presubmission Meeting
- Clarification Day 120
- Meeting at Day 150 (clarification of Agencys‘ position)
- Meeting at Day 210 (opinion)
Post authorization Activities:
- FUM (Discussion on conduct of clinical study)
-RMP
-PSUR
- Type II variations

Success Factors
- Good scientific discussions with the Co-Rapporteur
and assessment team in Agency
- Open communication and excellent guidance on
addressing questions
- Pro-activity of the Co-Rapporteur in issue solving
- Acceptance of Face-to-face meetings
Availability of CHMP member and assessment team
- Teleconferences (whenever needed)

Success Factors during the registration
- Thorough review of the very large dossier of first in
class NME
- Timely availability of the assessment reports and
reflection of Co-Rapporteurs view in those
- Transparency of review / Sharing of view
- CPO interaction to facilitate interface with Health
Authority

Success Factors during the registration
- Interrationsship between the Rapporteurs:
Close interrelationsship with Italy
- Peer Review (Germany):
Helpful to consolidate the questions

Conclusion
First Centralized Procedure with Hungary as
Co-Rapporteur
Overall very positive experience for Novartis