Transcript CSDG Annex VI of CTR Latest developments

CSDG Annex VI of CTR
Latest developments
Personal view of Tony Moult.
Any facts or opinions expressed in this presentation may not represent the
company view. These have been formed as the leader of the Work Group
formed by Efpia TDOC and CTWG to respond to the Annex VI aspects on
labels causing Industry concern
The sequence of events
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July 2012: draft CTR text published by the Commission for
stakeholder comment
April; 2014: Approved in the EU Parliament (EP) in ‘first reading’
and in Council. Published in the Official Journal: 27 May 2014
EFPIA input was mainly via the CTWG (Clinical Trial Working Group)
Prior to the EP vote in April 2014, some changes in Annex VI were
included at the insistence of a small number of MS. They were not
at the suggestion of the European Commission (EC). These changes
were documented in the official notes (Mid 2013) but visibility was
not high
Industry and the CTWG became aware of the changes after the
April parliament vote. The CTWG requested technical support and
expert help from the Technical Development Operational
Committee (TDOC).
Tony Moult as a member of that committee was requested to form
a joint TDOC/CTWG expert working group.
High level concerns
• New in Annex VI: expiry dating on inner as
well as outer pack.
• Efficacy and Quality of product
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Temperature and other special atmospheric
conditions may be an issue for date extensions
• Risk of error / tamper evidence on date
extension
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Error risk in depots is increased
Error risk in Clinic is significantly increased
Breaking of tamper evidence is needed and the
consequent risk
High level concerns
• New in Annex VI: expiry dating on inner as well as
outer pack (continued).
• Legibility
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Additional information makes space a problem .
Particularly with no small container exemption.
• Waste
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Small packs etc. may not be able to have date
extension labeling.
• Continuity of supply.
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Increased and more difficult process to extend date
High level concerns
• New in Annex VI: prohibiting use of electronic
systems (IRT/IWRS/IVRS/etc.*) to justify omission of
Expiry Date and other label elements.
• Expiry date is the current main concern.
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IRT control can be safer
Backward step compared with other regions (e.g. US)
Cost
• Prevents future innovation
*IRT: Interactive Response Technology, IWRS: Interactive Web Response System, IVRS: Interactive
Voice
Response Sytem
Timelines for implementation
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27 May 2014 CTR published.
28 May 2016* Effective if IT systems are in place.
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IT portal for submission and control is a prerequisite of CTR going
live.
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One year to implement from the effective date
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Challenging to achieve within stated timelines
Timelines will move back if there is any delay
Prior to commitment a independent audit of system is needed
We will have 6 months notice in the EC Journal of actual effective date
Studies from 28 May 2016* may use either process up to 28
May 2017*
All studies compliant by 28 May 2019*
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Long terms studies may need supply strategy now to meet this
or have mid study change.
* All dates move back if IT Portal is not completed, audited and this confirmed in the Journal 6 months before effective date.
Impact of current Annex VI Conclusion
• Will create great difficulty for IMPs
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Will reduce patient safety
• Will increase cost
• Will reduce innovation
• Will reduce EU competitiveness.
The sequence of events continued
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An initial letter of concern was drafted and sent to the
EC by the Director General of EFPIA (Richard Bergström)
the day before the CTR was published.
27th May 2014 Publishing of the Official Journal L158.
Volume 57 included Regulation (EU) No 536/2104.
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2014:158:FULL&from=EN
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This repeals Directive 2001/20/EC – The so call Clinical Trial
Directive.
The EC stated that it would be difficult to propose
amendments to the Annexes before application.
The EFPIA TDOC/CTWG work group produced and had
ratified a more detailed position paper (4 August 2014).
The sequence of events continued
• The position paper is the basis of communication
between EFPIA and the national trade
associations/ EC.
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A number of trade associations have responded about
contact with their authorities over the concerns
expressed.
Some member states agree with EFPIA. There is
reluctance to push change on this from some even if
they agree.
A copy of the position paper is provided (4 August 2014)
Current Situation
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Meeting with Fabio D’Atri of EC. 20th August 2014
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EFPIA could see no quality or safety benefit and asked what the
reasoning was for the changes.
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The response was : It was at the insistence of some member states
insisting on the changes.
From best personal recollection the justification of the Member States
was.
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“Essential information to the Patient or in an Emergency situation”
“Expiry Date labelling is linked to the Patient Number on the Label shortly before
dispensing and it would not be a problem”
The EFPIA position was reinforced by physical demonstration.
Discussions took place on how the situation could be remedied
ISPE presentation – Including two MS GCP inspectorates
Video produced and made public
http://www.efpia.eu/mediaroom//44/Rete205st-or-Expiry-Date-Labelling-in-Clinical-Trials
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Potential article in Script
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Meeting requested by ABPI with MHRA
Potential for Change from the current Annex VI
• Change has to be driven by Member States.
• Optimal solution; for the member state that
insisted on the current text to request the
change to the commission.
• On request to the commission some checks
would be made if there were other member
states that objected to the changes.
• Assuming consensus that the changes are
needed they could be introduced before the
CRT became effective. This would be via a
delegated act.
Best case
• EFPIA / National Trade Associations / Individual
Companies to make aware to the Member State
Authority contacts the need for change based
on innovation and patient safety needs.
• Change requested by Member States to the
commission ASAP.
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The best opportunity would be the Adhoc group
meeting of Member States meeting 27 November
2014
• Consensus building may result in an indication a
change is likely by the end of 2014.
• Change via a Delegated act may be possible by
May 2015.
Video then
Q and A?