CTFG Workshop on the Voluntary Harmonisation Procedure

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


VHP in general


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?


++

+

+

-

++

+

+

+ -

TimeCompetent Authorities Ethics Committees

Results

0

30

60

90

120

Present situation for the approval of a multinational Clinical Trial


EU Voluntary Harmonisation Procedure (VHP) for a multinational Clinical Trials

+

+

+

+ -

TimeCompetent Authorities Ethics Committees

Results

0

30

60

90

120

+

nat.approval


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


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


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


Experience with VHP


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


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


Statistics


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


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


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%


Conclusions


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