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>70300
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>2 000
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Paediatric regulation
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Key objectives of the new EU Paediatric Regulation
– To improve the health of the children of Europe by:
• increasing high quality research for medicinal products for children
• promoting the development and authorisation of such medicines at the EU level
• improving the information on medicines designed for children
– While avoiding unnecessary studies in children and not delaying the authorisation of medicines for adults
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EU Paediatric Regulation 3 Pilars
• Paediatric Investigation Plan (PIP)
• Reward (incentives) for studies conducted
• Paediatric Committee (PDCO) at the EMEA
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PIP
Includes timing of planned studies for all the paediatric population subsets applicable to
1. Pharmaceutical development (paediatric forms)
2. Pre-clinical studies (such as juvenile toxicity)
3. Clinical studies in children
Subsets of population to be considered (neonates, infants, children, adolescents)
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EU Paediatric Regulation Key elements
• Mandatory paediatric development for new products according to a PIP agreed upon by the PDCO (possible deferrals or waivers)
• Mandatory submission of paediatric data when filing new applications unless waiver or deferral approved by the PDCO
• New Marketing Authorisation Procedure for off-patent products (PUMA)
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Incentives
Incentives for new medicinal products and line extensions of patented medicinal products:
Reward for studies conducted:6-month extension of the patent or the
supplementary protection certificate (SPC)Covers new indications, new pharmaceutical
forms and new route of administration
For orphan medicines, 2-year additional market exclusivity (10+2)
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Incentives
Incentives for off-patent medicines specifically developed for children
New type of Marketing Authorisation (PUMA) Paediatric Use Marketing Authorisation
• Covers only the paediatric indication(s) and formulation(s)
• Enabling 10-year (8+2) data protection
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COMPOSITION:
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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Early
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PIP applications
EMEA received after 12 months of activities (by submission deadline 20.12.2008)
PIP applications* 356
corresponding to
Number of indications covered in the requests for PIPs or waivers: 596
including full waivers for the paediatric development for the whole indication 58
* ‘Application’ covers one or more indication(s)
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Applications by therapeutic area
19%
17%
13%5%
2%
2%
3%
5%
5%
6%
5%
8%
5%
2%
3%
Oncology
Endocrinology,gynecology, m etabolismCardiovascular
Neurology
Pain
Im m unology
Haem atology
Vaccines
Other
Infectious diseases
Pneum ology/Allergy
Uro/Nephrology
Psychiatry
Ophtalm ology
Diagnos is
Facilitate Research
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RapporteurRapporteur
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Peer ReviewerPeer Reviewer
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www.emea.europa.eu
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Thank you