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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 in the United States where specific rules to encourage the performance of clinical. trials in children introduced by the so-called "paediatric rule" and "paediatric exclusivity" adopted in 1998 and 1997 respectively. Only 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 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 the final aim of the EU Commission on this subject.

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

It is also proposed that an EU expert or working party 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 proposed to facilitate co-operation and avoid duplication.

The European Federation of Pharmaceutical Industries, speaking on behalf of the manufacturing companies, welcomed the proposals as generally positive. So also the reaction of over 70 other respondents.

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