The European Medicines Agency has the first set of drugs that have received “product-specific waivers” which means that they will not require further studies to be approved for paediatric use.
The waivers, which were adopted by the EMEA’s Paediatric Committee (PDCO) at its fifth meeting at the end of last week relate to Novartis’ immunosuppressant drug everolimus and two cardiovascular treatments, AstraZeneca’s Atacand Plus (candesartan cilexetil/hydrochlorothiazide) and Takeda Pharmaceutical Co’s Blopress Comp/Comp Forte (candesartan cilexetil/hydrochlorothiazide.
The agency noted that unless the applicant requests a re-examination of a PDCO opinion within 30 days, it is then “transformed” into an EMEA decision after 10 days. The PDCO claimed that it has “continued its interaction with academic experts” that any waivers it issues reflect “the state-of-the-art knowledge in the different paediatric fields, eg cardiovascular, ophthalmology and bone diseases”.
At the meeting, the PDCO also adopted guidance on the content and the format of data to be collected by member states on all existing uses of
medicinal products in the paediatric population, which should be
completed by the end of 2008 and must be communicated to the agency. This data will be used by the PDCO to establish an inventory of paediatric