paediatric medicinal products
A large proportion of the medicinal products prescribed to
children have not yet been (sufficiently) investigated in children.
Consequently, there is insufficient certainty about the efficacy
and safety of their use in children.
MEB attaches considerable importance to obtaining the right data
about medicinal products for children. The development of new
knowledge, as well as additional information about the use of
medicinal products in children, can contribute to better
treatment.
The MEB intends to increase and extend its expertise in
the field of paediatrics. A Consultative Group of Paediatricians
has been set up for this. Its members include several leading
paediatricians/pharmacists within the Netherlands in the area of
paediatric pharmacotherapy.
Information about paediatric medicinal products:
Paediatric
Committee
On 26 January 2007 the new regulation
concerning medicinal products for paediatric use was published. As
a result of this new regulation, the EMeA has established the new
Paediatric Committee, which will assume a key position in
monitoring registration studies for paediatric medicinal
products.
Currently, the application for a marketing authorisation for a
new medicinal product must also contain the results of research
performed on the basis of a so-called PIP (paediatric investigation
plan). This PIP must be approved by the Paediatric Committee (PC).
The PC can also grant deferment for research in children or decide
that this research does not need to be performed (e.g., because the
medicinal product is intended for diseases that do not occur in
children). As a reward for the investigation of new medicinal
products for children, the patent for the medicinal product (in
effect the SPC = additional protective certificate) will be
extended by 6 months.
The option of marketing a special paediatric medicinal product
(Paediatric Use Marketing Authorisation - PUMA) will be created for
existing medicinal products. A special protective mechanism will
apply to these products: even if the paediatric medicinal product
is a line extension of an existing medicinal product, a new
protective period for the dossier will nonetheless be created.
Consultative Paediatricians
Group
Just like the European Commission, the MEB
attaches considerable importance to:
- the development of new medicinal products for children;
- further research into the use of existing medicinal products in
children;
- the development of new pharmaceutical forms of existing
medicinal products for children;
- remaining focused upon medical (research) practice while
realising its tasks.
The MEB wants to extend and expand its expertise in the field of
paediatrics by establishing the Regulation on Medicinal Products
for Paediatric Use and the Paediatric Committee in Europe in the
near future. Cooperation is consequently being sought with a number
of leading paediatricians/pharmacists in the Netherlands in the
area of paediatric pharmacotherapy.
The Consultative Group of Paediatricians was officially
appointed on 1 February 2006.
The composition of the group is as follows:
- J.N. van den Anker - Children's National Medical Center,
Washington; Erasmus MC-Sophia Children’s Hospital, Rotterdam
- H. van den Berg - AMC, Emma Children’s Hospital, Amsterdam
- F. Groenendaal - UMC, Wilhelmina Children’s Hospital,
Utrecht
- N.G. Hartwig - Erasmus MC-Sophia Children’s Hospital,
Rotterdam
- M. de Hoog - Erasmus MC-Sophia Children’s Hospital, Rotterdam;
NKFK (Dutch Knowledge Centre for Paediatric Pharmacotherapy)
- H.A. Moll - Erasmus MC-Sophia Children’s Hospital,
Rotterdam
- M. Offringa - AMC, Emma Children’s Hospital, Amsterdam; NKFK
(Dutch Knowledge Centre for Paediatric Pharmacotherapy); MCRN
(Medicines for Children Research Network)
- C.M.A. Rademaker - UMC, Wilhelmina Children’s Hospital,
Utrecht
- P.F. Schothorst - UMC, Utrecht
- B.A. Semmekrot - Canisius-Wilhelmina Hospital (CWZ),
Nijmegen
- R.N. Sukhai - LUMC, Willem-Alexander Child and Youth
Centre
- H.A.W.M. Tiddens - Erasmus MC; Sophia Children’s Hospital,
Rotterdam
- M.M. van Weissenbruch - VUMC, Amsterdam
The following persons participate on behalf of the MEB:
- J.A.J.M. Taminiau - chairman
- A.I.M. Wesseling - secretary
- H.G.M. Leufkens
- A.F.A.M. Schobben
The group has the following tasks:
- informing each other about significant developments in
paediatric medicinal products;
- critically monitoring the MEB in its activities related to
authorisation and recommendation in the area of paediatric
medicinal products;
- peer review of MEB reports about paediatric medicinal products
at the European level
- providing recommendations if the MEB requires expertise or
wishes to consult an expert;
- participating in national and international meetings on behalf
of the MEB.
Links