The Pharmaceutical Journal
Vol 279 No 7470 p320
22 September 2007

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News summary

Consultation starts on list of diseases for which new drugs will not need paediatric tests

Consultation has started on a draft list of diseases for which new drugs will automatically be exempt from recently introduced European requirements to test their suitability for use in children (PJ, 13 January, p39).

The list has been drawn up so that companies do not have to apply for waivers to the requirement to submit paediatric investigation plans when they are developing new medicines to treat conditions that do not affect children.

The list includes a number of cancers and other conditions, such as Alzheimer’s disease, vascular dementia and age-related macular degeneration.

Comments on the proposed list can be sent to the European Medicines Agency until 5 October. The revised list will be finalised on 26 October 2007.