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The situation is definitely better in the United States where specific rules to encourage the performance of clinical. trials in children were introduced by the so-called "paediatric rule" and "paediatric exclusivity" adopted in 1998 and 1997 respectively. Only last January the US Congress reviewed the latter legislation and widened its scope in view of its success, and abolished the former.
One of the advantages that the US has over the EU in the area of clinical trial development is the fact that there is regulatory oversight through the Investigational New Drug application from an early stage of development. And this seems to be the final aim of the EU Commission on this subject.
The Commissions' paper is suggesting the creation of a central database that would help determine priorities for future work and ensure that the same information and treatment possibilities are available throughout the EU.
It is also being proposed that an EU expert group or working party be created within the European Medicines Evaluation Agency with specific responsibility for all aspects relating to development, availability and follow-up of paediatric medicines. A pan-European network of specialist paediatricians is also being proposed to facilitate co-operation and avoid duplication.
The European Federation of Pharmaceutical Industries, speaking on behalf of the manufacturing companies, has welcomed the proposals as being generally positive. So also was the reaction of over 70 other respondents.Teacher: Michael
Many articles taken from 'A word with the doctor', by Dr. John Windsor.
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