�Opinions on paediatric investigation plans adopted
The Paediatric Committee (PDCO) adopted positive opinions on pediatric investigation plans (PIPs)
for the following medicines:
-- Dabigatran etexilate, from Boehringer Ingelheim International GmbH, in the alterative area
of haematology and haemostaseology;
-- Thrombin alfa (recombinant), from Bayer HealthCare AG, in the therapeutic region of
hematology and haemostaseology;
-- Pramipexole dihydrochloride monohydrate, from Boehringer Ingelheim International
GmbH, in the sanative area of neurology;
-- Retigabine from Valeant Pharmaceuticals Ltd, in the therapeutic area of neurology.
The PDCO adopted negative opinions for PIPs for ezetimibe and simvastatin, from Merck Sharp &
Dohme, and for nicotinic acid (in an extended release form), simvastatin and laropiprant, from
Merck Sharp & Dohme (Europe) Limited, both in the therapeutic area of endocrinology and
metabolism. The PDCO adopted subsequently on its own apparent movement positive opinions on full waivers for
these medicines in all subsets of the pediatric population, on the grounds that these products do not
represent a significant therapeutic benefit over existing treatments for the paediatric population.
A paediatric investigation be after (PIP) sets out a programme for the developing of a medicine in the
paediatric population. The PIP aims to bring forth the necessary quality, guard and efficaciousness data through
studies to support the authorisation of the medicinal drug for employment in children of all ages. In some cases, a PIP
may include a waiver to study peerless or more age groups of children, or a deferral when it is appropriate
to conduct studies in adults prior to initiating studies in the paediatric population, or when studies in
the paediatric population would take yearner to conduct than studies in adults.
Opinions on product-specific waivers
The PDCO adoptive an opinion for a product-specific release, recommending that the obligation to
submit data obtained through clinical studies with children be waived in all subsets of the paediatric
population, for bortezomib, from Janssen-Cilag International, in the therapeutical area of oncology.
Waivers can be issued if there is grounds showing that the medicinal product concerned is likely to be
ineffective or unsafe in the paediatric population, or that the disease or condition targeted occurs just
in grownup populations, or that the specific medicinal product does not represent a significant therapeutic
benefit over existing treatments for paediatric patients.
The PDCO discussed the applicability of class waivers for products intended to treat conditions
included in the heel of class waivers. Companies developing a product for a condition included in the
lean of social class waivers can request substantiation of whether the cRO of the EMEA conclusion on a class
waiver for a condition is applicable to their product. Upon review by the PDCO, companies will
receive an consequence letter substantiating whether or not their product is considered to fall under the scope
of the EMEA Decision on social class waivers.
Compliance check with PIPs
The PDCO endorsed a document which describes the EMEA obligingness check with an in agreement PIP,
which is a prerequisite for the validation of new marketing authorisation applications and applications
for extensions or variations of indications. In add-on to the Paediatric Committee, the EMEA has
liaised with the EMEA's Committee for Medicinal Products for Human Use (CHMP) and the Coordination
Group for Mutual Recognition & Decentralised Procedures for Human Medicines for the
drawing of this document.
As of 26 July 2008, pharmaceutical companies who submit an application for a marketing
authorization for a medicine take to provide either the results of studies in children conducted in
accordance of rights with an approved PIP or an EMEA determination on a waiver or on a deferral. This will apply
from 26 January 2009 for medicines that ar already authorized and for which a company is
submitting an application for an denotation of indication.
At the request of the Committee for Medicinal Products for Human Use, a competent authority or the
applicant, the PDCO will value and articulate an belief on the compliance of the lotion for
marketing authorisation with the in agreement paediatric probe plan interested, i.e. assess whether all
measures agreed in a PIP have been carried out in accordance with the EMEA decision on the PIP.
Compliance is one of several prerequisites for obtaining the rewards and incentives provided for by
the Paediatric Regulation.
Cooperation with US-FDA
The PDCO welcomed the attendance at the group meeting of a representative of the US Food and Drug
Administration (FDA) in the framework of the Principles of Interaction between EMEA and FDA
Pediatric Therapeutics. According to the terms of these principles, EMEA staff may attend the FDA's
Pediatric Implementation Team meetings and FDA staff may wait on the EMEA's Paediatric
Committee meetings to enable regulators from either delegacy to take note operational activities, and to
optimise mechanisms and timing of data exchanges.
The objectives of the cooperation between the EMEA and FDA in the field of pediatric medicines ar
to facilitate the model for world-wide paediatric evolution plans, compatible for both agencies, with
the aspire of avoiding exposing children to unneeded trials.
The next meeting of the PDCO volition be held on 27-29 August 2008.
1. PDCO opinions on PIPs and waivers ar transformed into EMEA decisions within the
timeframe laid down by the Paediatric Regulation (Regulation (EC) No 1901/2006, as
amended). The decisions canful be establish here.
2. The Principles of Interaction between EMEA and FDA Pediatric Therapeutics can be found on
the EMEA website hither (PDF).
3. The document on procedural advice for validation of new marketing authority applications
for extensions/variations and compliance check with an agreed PIP is published in the
Medicines for children section of the EMEA website.
4. More info about the PDCO and the Paediatric Regulation is available in the 'Medicines
for children' section of the EMEA internet site.
European Medicines Agency
The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary employment.
http://www.emea.europa.eu
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