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![Page 1: An agency of the European Union Daniel Brasseur PDCO European Medicines Agency “5 th anniversary Paediatric Regulation” PDCO Achievements.](https://reader037.fdocuments.us/reader037/viewer/2022102800/56649c775503460f9492bb42/html5/thumbnails/1.jpg)
An agency of the European Union
Daniel Brasseur PDCO European Medicines Agency
““55thth anniversary Paediatric Regulation” anniversary Paediatric Regulation”
PDCO AchievementsPDCO Achievements
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Paediatric Regulation
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Take home message
Good research in children is a need & time is needed to develop good research
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Research Needs in Paediatric Medicines
Total Opinions (+&-) 700
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Research Needs in Paediatric Medicines
PIP Opinions (= need) 500
Total Opinions 700
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Research Needs in Paediatric Medicines
PIP Opinions (= need) 500
Total Opinions 700
70% out of 700
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PDCO AchievementsPDCO Achievements Plan
Implementation of procedures
PIP Evaluation and Outcomes
Survey of the Needs
Priority list & FP7
Enprema
Challenges
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99
9
Overview of PDCO Procedure
ReStartClock
StopClock60 DAYS60 DAYS 60 DAYS60 DAYS
Adoption of
Opinion&
Final Report
StartClock
DecisionDecision
Evaluate ChangesFind AgreementFinalize PlanPublish Decision
Opportunity for the
Company to introduce Modifications
Understand PlanDetect ProblemsIdentify ExpertsPropose Changes
Adoption of Opinion,
orRequest for Modification
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1010
10
Overview PDCO of Procedure
ReStartClock
StopClock60 DAYS60 DAYS 60 DAYS60 DAYS
Adoption of
Opinion&
Final Report
StartClock
DecisionDecision
Evaluate ChangesFind AgreementFinalize PlanPublish Decision
Opportunity for the
Company to introduce Modifications
Understand PlanDetect ProblemsIdentify ExpertsPropose Changes
Adoption of Opinion,
orRequest for Modification
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1111
11
Overview PDCO of Procedure
ReStartClock
StopClock60 DAYS60 DAYS 60 DAYS60 DAYS
Adoption of
Opinion&
Final Report
StartClock
DecisionDecision
Evaluate ChangesFind AgreementFinalize PlanPublish Decision
Opportunity for the
Company to introduce Modifications
Understand PlanDetect ProblemsIdentify ExpertsPropose Changes
Adoption of Opinion,
orRequest for Modification
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PDCO AchievementsPDCO Achievements Plan
Implementation of procedures
PIP Evaluation and Outcomes
Survey of the Needs
Priority list & FP7
Enprema
Challenges
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1515
15
5 CHMP members+
1 members per Member State not yet represented
+6 members from families
& HCP associations
Each member has an alternate
PDCO PDCO
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Rapporteurships
0
10
20
30
40
50
60
70
Aus
tria
Be
lgiu
m
Bulg
aria
Czec
h Re
publ
ic
D
enm
ark
Esto
nia
Fi
nlan
d
Fr
ance
G
erm
any
Hea
lthca
re a
nd A
cade
mia
Hun
gary
Ic
elan
Irel
and
Ita
ly
La
tvia
Lith
uani
a
Luxe
mbo
urg
M
alta
N
orw
ay
Pa
tient
s' O
rgan
isati
on
Pola
nd
Port
ugal
Ro
man
ia
Slov
enia
Spai
n
Swed
en
The
Net
herl
ands
U
nite
d Ki
ngdo
m
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Update EMA/PDCO ReportRequest forModification
PIP Procedure First step = 7 “expert” inputs
Re-StartRe-StartClockClock
StopStopClockClock
Peer Reviewer’sComments
Day 27
Rapporteur’swritten
ContributionDay 20
Members’written
CommentsDay 30-55
StartStartClockClock
1st Rapp Oral Present.
at PDCODay 30
1st PDCO Discussion
+OE?Day 60
EMASm Report
Day 1
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18
Update EMA/PDCO ReportRequest forModification
PIP Procedure First step = 7 “expert” inputs
Re-StartRe-StartClockClock
StopStopClockClock
Peer Reviewer’sComments
Day 27
Rapporteur’swritten
ContributionDay 20
Members’written
CommentsDay 30-55
StartStartClockClock
1st Rapp Oral Present.
at PDCODay 30
1st PDCO Discussion
+OE?Day 60
EMASm Report
Day 1
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PIP Procedure Second step = 9 “expert” inputs
3rd PDCODiscussion
Final ReportDay 120
OE= oral explanation
Rapporteur’s Comments on Modifications
Day 80
PReviewer’s Comments on Modifications
Day 88
UpdateEMA/PDCOSm ReportDay 110
Members’Final Comments
to EMADay 105
PDCOPDCOOpinionOpinion
EMEAEMEADecisionDecision
Re-StartRe-StartClockClock
Company’sPIP Re-
SubmissionDay 61
EMASm Report
UpdateDay 71
2nd Rapp Oral
Present.
Day
& 2nd PDCO Discussion
+OE?90 .
OE?Final EMA DecisionDay 130
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20
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Evaluation procedure of PIPsEvaluation procedure of PIPs
PDCO FWG Formulation Group – monthly meeting
– PDCO members (Chair: Dr Siri Wang) + external experts (hospital, academia).
– Discussion on formulation aspects and reporting to the PDCO.
PDCO Paediatric Committee - monthly meeting
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22
Applications assessed by FWGApplications assessed by FWG
Around 1000 PIPs
validated PIP/waiver
applications
(March 2011)
5484
220
0
50
100
150
200
250
2008 2009 2010-2011
PIPs reviewed by Quality Sector
No. of PIPs60%
15/m
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2323
Critical Points for Paediatric FormulationsCritical Points for Paediatric Formulations
• Route of administration
• Appropriate dosage forms
• Excipients - 50% of the PIPs- choice excipient, safety, level, side effects……
• Taste and palatability
• Delivery devices
• Rate of infusion
• Volume to be administered
• Wastage
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Regulatory references 2 Regulatory references 2
(Draft) Guideline on pharmaceutical development of medicines for
paediatric use
• Collaborative work between QWP, PDCO, and external experts.
• Public consultation aimed very soon.
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WGroups
ReStartClock
StopClockDAY 0 or 30DAY 0 or 30 DAY 60 or 90DAY 60 or 90
StartClock
Opinion
Opportunity to discuss need for
juvenile animalstudies
Opportunity to discuss need for
juvenile animalstudies
Non-Clinical
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28
NcWG discussions November 2008 - September 2011
0
5
10
15
20
25
Num
ber
of P
IPs
disc
usse
d
Re-discussions
New PIPs
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WGroups
ReStartClock
StopClockDAY 0 or 30DAY 0 or 30 DAY 60 or 90DAY 60 or 90
StartClock
Opinion
Opportunity to discuss
extrapolations statistics
?modelling
MethodologyMethodology
Opportunity to discuss
extrapolations statistics
?modelling
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Reasonable to assume equivalence of disease Children = Adults- similar progression?- similar response to intervention?
Reasonable to assume similar concentration response (C-R)
in Children = Adults?
Conduct PKPK studiesConduct S S & EE trials
Conduct PK studies to achieve levels similar to Adults Conduct SS trials
Conduct PKPK/PDPD studies to get CR for PD measurementConduct PKPK to achieve target concentration based on CRConduct SS & EE trials
Is there a PD measurement
that can be used to predict EE?
NoNo
NoNo
NoNo
YesYes
YesYes
YesYes
YesYes
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31 “Classical Power”
Overall population
Affected population
Sick population (patients)
Available Population(volunteers) Resources
Project
Diagnosis
Prevalence
Participating Population (Cases)
Protocol
CT
Methodological constraints in small populations
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Modelling and Simulation!
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Definition of ModelsPublished Paradigm
PBPK (Physiologically Based PK)
PBPK-PD
POP PK (Population Based PK)
POP PK/PD
Disease progression models and response models
Kinetic (K)–PD models
Toxicity/AE models
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PDCO AchievementsPDCO Achievements Plan
Implementation of procedures
PIP Evaluation and Outcomes
Survey of the Needs
Priority list & FP7
Enprema
Challenges
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60%
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How many trials have effectively started?
How many children to be included?
How many indications to be developed?
What is the expected product attrition rate?
What are finalisation delays overall?
6%
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PDCO AchievementsPDCO Achievements Plan
Implementation of procedures
PIP Evaluation and Outcomes
Survey of the Needs
Priority list & FP7
Enprema
Challenges
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An agency of the European Union
Presented by: Dr. Radu BotgrosScientific Administrator, Safety and Efficacy of Medicines
REPORT ON THE SURVEY OF ALL PAEDIATRIC USES OF MEDICINAL PRODUCTS IN EUROPEestablished according to article 42of Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use
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Results (I)
Most frequent medicines used off-label/ unauthorised: – antiarrhythmics, – antihypertensives (rennin-angiotensin inhibitors and beta-
blockers), – proton pump inhibitors and H2-receptor antagonists,– antiasthmatics, and – antidepressants (mainly selective serotonin reuptake
inhibitors, serotonin-norepinephrine reuptake inhibitors and tricyclic antidepressants).
High rate of off-label use of oral contraceptives in ados– mainly in Scandinavia.
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Results (II)
Extensive off-label use of ABs in very young children.– macrolides
– betalactamines plus betalactamase inhibitors
– carbapenems
•Corticosteroids used off-label in the systemic treatment of very young children.
– Some for systemic use (e.g. dexamethasone) are not even authorised in some countries (Norway)
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Results (III)
Analysis of the pharmaceutical forms
• both oral and parenteral formulations are being used unauthorised or off-label,
• common reason: lack of appropriate dosages and strengths for the treated age groups.
off-label use of
– multivitamins
– many antiasthmatics.
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PDCO AchievementsPDCO Achievements Plan
Implementation of procedures
PIP Evaluation and Outcomes
Survey of the Needs
Priority list & FP7
Enprema
Challenges
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4646
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4747
PDCOevaluation
List DG Research
evaluation
PIP
DG Research
EMA
Funding
Applicant’sproject
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4848
PDCOevaluation
List DG Research
evaluation
PIP
DG Research
EMA
Funding
Applicant’sproject
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4949
PDCO
PIP
List
DG Research EMA
Applicant’sdraft PIP
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5050
PDCO
PIP
List
DG Research EMEA
Applicant’s project + agreed PIP
Funding
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PDCO AchievementsPDCO Achievements Plan
Implementation of procedures
PIP Evaluation and Outcomes
Survey of the Needs
Priority list & FP7
Enprema
Challenges
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Researcher
HCP
Industry
Regulators
Academia
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53
PDCO AchievementsPDCO Achievements Plan
Implementation of procedures
PIP Evaluation and Outcomes
Survey of the Needs
Priority list & FP7
Enprema
Challenges
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54EFPIA/EMA Infoday - 23 May 2011 1
Efpia survey on impact of the paediatric regulation on marketing authorization holders (Jan 2007 – Jun 2010)
Judith Creba (Novartis Pharma)
Craig Johnson (Eli Lilly)
Angelika Joos (Merck Sharp & Dome)
23 May 2011
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55EFPIA/EMA Infoday - 23 May 2011 6
34 companies provided input
biologicals
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Timing of Art.7 PIP submissions for new medicinal products (information received on N=146 out of 168 submitted PIPs)
EFPIA/EMA Infoday - 23 May 2011 1
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5757
Scientific Advice (paediatric only)
57
SA +PA
Paed
%2007 281 7.5
2008 320 7.2
2009 388 7.7
2010 400 8
0
5
10
15
20
2007
2008
2009
2010
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PDCO AchievementsPDCO Achievements Conclusion
Change of mindset with Industry
475 PIPs agreed
Start of Network of Networks
Limited view of immediate impact…
Better overview of Paediatric needs
Trials of off-label drugs (FP7)
Reflection ongoing to improve/ facilitate work
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Take home message
Good research in children is a need & time is needed to develop good research
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