ctfg workshop on the voluntary harmonisation procedure
TRANSCRIPT
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA
Experience with VHP
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of Multinational
Clinical Trial Applications 30.April 2010, Bonn, Germany
Wolfram KannegießerClinical Trial Unit
Paul-Ehrlich InstitutePaul-Ehrlich-Str. 55-59
63225 LangenGermany
Fax: +49 +(0)6103 771277Telefon: +49 +(0)6103 771812E-Mail: [email protected]
http://www.pei.de
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 2
Structure
of the presentation
1.
VHP in general
2.
Experience with VHP in the beginnig
3.
Statistics
4.
Conclusion
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 3
VHP in general
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 4
Harmonisation of divergent decisions between Member States
Offer to the Sponsors to get one Clinical trial approved in many Member States in acceptable times
WHY a Voluntary Harmonisation Procedure?
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 5
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TimeCompetent Authorities Ethics Committees
Results
0
30
60
90
120
Present situation for the approval of a multinational Clinical Trial
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 6
EU Voluntary Harmonisation Procedure (VHP) for a multinational Clinical Trials
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TimeCompetent Authorities Ethics Committees
Results
0
30
60
90
120
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nat.approval
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 7
Max.5 Days
The VHP consists of three phases
VHP-Phase 1:Request for a VHP at any time -
Request by sponsors including the identification of the participating NCAs and submission of a full dossier
-
Decision by Member States to participate in the VHP
VHP-Phase 2: the assessment phase-
Review of the CTA by all the participating NCAs
-
1st common position around D30, total period maximum 60 days-
Administrative co-ordination by the VHP coordinator
VHP-Phase 3: the national Member States step-
Formal CTA applications to NCAs.
-
CTA approval
by
NCAs within
short
timelines
(after
positive VHP)
Max. 60 Days
10 Days
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 8
Key features of the Voluntary Harmonisation Procedure
Only electronic documents sent to one address (one stop shop)Only general documents required, which are part of any clinical trial application (Protocol, Investigators brochure, Investigational Med. Product Dossier)Reliable timelines for Sponsor and Member StatesHarmonised scientific discussion resulting in harmonised applications in the Member States -
no tracking of Member States specific modifications necessary
-
consolidated lists of grounds for non-acceptance, if needed
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 9
Documents
to be
submitted
for the VHP
VHP Application dossier :
1. General Information1.1 Covering Letter including EudraCT number1.2 Application form, if available1.3 List of NCAs concerned
2. Protocol related folder2.1 Current Protocol (including the summary/synopsis)
3. IMP related folder3.1 IB3.2 IMPD (including viral safety data if applicable)3.3 Scientific advises and PIP summary report (if applicable)
4. NIMP related folder, if applicable
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 10
Experience with VHP
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA
Experience
on VHP in the beginning
Problems in the start-up period:Totaly new procedure for all participantsFeedback of the participating member states on request not in every case satisfactorily (no reaction on VHP request or no reaction within timelines)No leading member state:This had an effect on the length of the list of GNAs and the duration of the TCsRolling submission of documents in the Accelerated Procedure H1N1
W. Kannegießer Page 11
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 12
Proposal of the EMA Task force to channel all clinical trials into the VHP to avoid diverging assessmentsLetter by EMA to the sponsors proposing to join2 Participants-
2 by applicant 1
-
9 by applicant 21 Rejection (applicant 3), only nat. applicationNo reaction (applicant 4), only national ap-plication in GermanyAll others no reaction (also not nationally)
Accelerated
VHP for pandemic
influenza
Vaccines
Few Member States per Applicat
ion 1-2
Rolling subm
ission of doc
uments
Extreme pres
sure after s
ubmission of
bits and pie
ces
Conclusion o
f CTFG : Never again
accelerated
VHP with a rolling
submission
of documents
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 13
Statistics
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 14
VHP numbers (March 2009-April 2010)
30 applications -
19 standard VHP
-
11 accelerated VHP (Pandemic Influenza Vaccines)
23 finished positive -
1 negative (GNA not addressed)
•
But 2 only approved by MS after modification of batch records
-
2 withdrawals (before dossier subm.) -
4 ongoing
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA
Participating
Member
States
in 28 VHPCountry No. of VHPGermany 20France 16Spain 16Belgium 9UK 8Austria 7Sweden 7Czech Republic 7Portugal 6Hungary 6Romania 5Greece 4Finland 4Denmark 4Italy 2Norway 2Ireland 2The Netherlands 1Bulgaria 1Lativia 1Iceland 1
Country reject joining VHPPolandThe Netherlands
The following MS weren‘t selected for a VHP:EstoniaMaltaCyprusLuxemburgSloveniaLithuania
W. Kannegießer Page 15
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 16
Summary
results
of the standard
VHPAverage time used for a VHP: 52 days
Mean of 8 Member States per standard VHP-
Range 2-18
Member States
Time until national CTA by applicant: mean ~18d-
Range 1-45 days
Time for national approval by NCAs: mean ~12d-
Range 1-80 days
Commercial applicants 80%,Non-commercial applicants 20%
Biologicals 20%Chemicals 80%
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 17
Conclusions
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTA W. Kannegießer Page 18
ConclusionsThe Voluntary Harmonisation Procedure is an efficient tool to achieve harmonised and quick approvals of clinical trials in many Member States of the EU in one procedure
VHP offers a one-stop-shop for CTAs
VHP accepts electronic submissions only
Time lines for applicants and Competent Authorities are reliable and are met
Substantial Amendments are now included in the VHP
CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of multinat. CTAH. Krafft; Paul-Ehrlich Institute; VHP Thank
you
for your
attention