Intensive contacts with the European Parliament have enabled the Austrian Presidency to achieve an early agreement (at second reading) on the Paediatric Medicines Regulation. This regulation will ensure that medicinal products can be produced specifically for children in future. That means account will be taken of child physiology when developing new medicines.
“Most of the medicinal products on the market have not been specifically authorised for use in children”, said Austria’s Health Minister Maria Rauch-Kallat. “Doctors are therefore often forced to prescribe medicines for use in children even though experience concerning their efficacy and safety in this patient population is not available. It is not enough simply to prescribe smaller doses for children, however.”
The regulation provides for the establishment of a Paediatric Committee within the European Medicines Agency, which will be responsible for the assessment and agreement of paediatric investigation plans. A key provision of the new regulation is a six-month extension of patent protection for medicinal products if:
A new type of marketing authorisation for paediatric use is proposed for medicines whose patents have expired (but which have been specifically developed for use in children); this affords the products ten years of data protection.
"The EU Paediatric Medicines Regulation guarantees the maximum possible safety in child medication", Rauch-Kallat concluded.
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