Paediatric medicines rules may be eased
The European Parliament's environment committee has moved to ease requirements proposed in a planned EU directive for medicine manufacturers always to consider the potential effect of adult medicines on children.
The European Parliament's environment committee has moved to ease requirements proposed in a planned EU directive for medicine manufacturers always to consider the potential effect of adult medicines on children.
It has tabled amendments that would allow "justified derogations" from requirements proposed by the European Commission that firms should present results of paediatric studies on medicines at the same time as those from human pharmacokinetic studies on adults.
The committee also proposed amendments to the full parliament that would strengthen the independence of a European Medicines Agency (EMEA) paedi-atric committee monitoring child usage of adult pharmaceuticals. MEPs voted that members of this committee should not "have financial or other interests in the pharmaceutical industry which could affect their impartiality".
A more detailed change proposed suggested that for five years after the regulation enters into force, applications for extending supplementary protection certificates should be lodged not later than six months before their expiry.