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Samples in periodicals archive:
NYSE Amex: PBTH), today announced that its paediatric investigation plan for clinical development of its long-acting human growth hormone (hGH-CTP) has been accepted for review by the Paediatric Committee of the European Medicines Agency (EMA).
JERUSALEM, Israel, January 18 /PRNewswire/ -- The Gamida Cell-Teva Joint Venture (JV) announced today that the Paediatric Committee (PDCO) of the EMA has granted product specific waivers for StemEx for all subsets of the paediatric population (birth to 17 years of age) in all conditions.
In the meantime, companies may approach the Paediatric Committee, which will be established by 26 July 2007, to agree a PIP.
The regulation also sets up a paediatric committee at the European Medicines Agency that will agree paediatric investigation plans with companies and determine research priorities.
The committee also proposed amendments to the full parliament that would strengthen the independence of a European Medicines Agency (EMEA) paediatric committee monitoring child usage of adult pharmaceuticals.