�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 sanative area
of haematology and haemostaseology;
-- Thrombin alfa (recombinant), from Bayer HealthCare AG, in the therapeutic area of
haematology and haemostaseology;
-- Pramipexole dihydrochloride monohydrate, from Boehringer Ingelheim International
GmbH, in the therapeutical area of neurology;
-- Retigabine from Valeant Pharmaceuticals Ltd, in the therapeutic area of neurology.
The PDCO adopted negative opinions for PIPs for ezetimibe and zocor, from Merck Sharp &
Dohme, and for nicotinic acidulent (in an extended release shape), simvastatin and laropiprant, from
Merck Sharp & Dohme (Europe) Limited, both in the therapeutic field of endocrinology and
metabolic process. The PDCO adopted after on its own motion positive opinions on full waivers for
these medicines in all subsets of the paediatric population, on the grounds that these products do not
map a substantial therapeutic benefit over existing treatments for the pediatric population.
A paediatric investigation plan (PIP) sets out a programme for the ontogenesis of a medicine in the
pediatric population. The PIP aims to generate the necessary quality, safety and efficacy data through and through
studies to support the authorisation of the medicine for purpose in children of all ages. In some cases, a PIP
may include a waiver to study unitary 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 thirster to guide than studies in adults.
Opinions on product-specific waivers
The PDCO adopted an opinion for a product-specific waiver, 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 butt be issued if there is evidence showing that the medicative product concerned is likely to be
ineffective or unsafe in the pediatric population, or that the disease or condition targeted occurs only
in adult populations, or that the specific medicative product does not represent a significant therapeutic
benefit over existent treatments for paediatric patients.
The PDCO discussed the applicability of class waivers for products intended to treat conditions
included in the list of course waivers. Companies developing a product for a condition included in the
list of year waivers tin request check of whether the scope of the EMEA determination on a class
discharge for a condition is applicable to their product. Upon review by the PDCO, companies will
receive an issue letter confirming whether or not their product is considered to fall under the scope
of the EMEA Decision on class waivers.
Compliance check with PIPs
The PDCO endorsed a document which describes the EMEA conformation check with an in agreement PIP,
which is a requirement for the validation of new marketing authorisation applications and applications
for extensions or variations of indications. In addition 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
drafting of this document.
As of 26 July 2008, pharmaceutical companies who defer an application for a marketing
say-so for a medicine have to cater either the results of studies in children conducted in
accordance of rights with an approved PIP or an EMEA decision on a waiver or on a deferral. This will apply
from 26 January 2009 for medicines that are already authorised and for which a company is
submitting an application for an extension of indication.
At the request of the Committee for Medicinal Products for Human Use, a competent authority or the
applier, the PDCO will assess and formulate an judgment on the compliance of the application for
merchandising authorisation with the agreed paediatric investigating plan concerned, i.e. assess whether all
measures agreed in a PIP have been carried out in accordance with the EMEA conclusion 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 get together 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 take care the EMEA's Paediatric
Committee meetings to enable regulators from either way to observe operational activities, and to
optimise mechanisms and timing of selective information exchanges.
The objectives of the cooperation between the EMEA and FDA in the subject of paediatric medicines ar
to facilitate the framework for worldwide paediatric development plans, compatible for both agencies, with
the aim of avoiding exposing children to unnecessary trials.
The next coming together of the PDCO will be held on 27-29 August 2008.
1. PDCO opinions on PIPs and waivers are transformed into EMEA decisions within the
timeframe laid down by the Paediatric Regulation (Regulation (EC) No 1901/2006, as
amended). The decisions tin can be ground here.
2. The Principles of Interaction between EMEA and FDA Pediatric Therapeutics can be found on
the EMEA website here (PDF).
3. The document on procedural advice for validation of new marketing mandate 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 information about the PDCO and the Paediatric Regulation is available in the 'Medicines
for children' division of the EMEA web site.
European Medicines Agency
The European Medicines Agency (EMEA) is a decentralized 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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