Better medicines for children: EU Commission initiative to get best and safest treatments for children Part 5

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Better medicines for children: EU Commission initiative to get best and safest treatments for children Part 5 (Teacher: Michael)

The situation is definitely better in United States where specific rules to encourage performance of clinical. trials in children were introduced by so-called "paediatric rule" and "paediatric exclusivity" adopted in 1998 and 1997 respectively. Only last January US Congress reviewed latter legislation and widened its scope in view of its success, and abolished former.

One of advantages that US has over EU in area of clinical trial development is fact that there is regulatory oversight through Investigational New Drug application from early stage of development. And this seems to be final aim of EU Commission on this subject.

The Commissions' paper is suggesting creation of central database that would help determine priorities for future work and ensure that same information and treatment possibilities are available throughout EU.

It is also being proposed that EU expert group or working party be created within European Medicines Evaluation Agency with specific responsibility for all aspects relating to development, availability and follow-up of paediatric medicines. 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 manufacturing companies, has welcomed proposals as being generally positive. So also was reaction of over 70 other respondents.

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