EU pediatric rules five years on: "culture change", but results still patchy
This article was originally published in Scrip
The EU's Paediatric Regulation has effected a "culture change" in Europe, to the extent that pharmaceutical companies have come to see clinical trials in children as an integral part of drug development, and the authorities now have a large amount of hitherto unpublished and valuable pediatric trial data at their disposal.
You may also be interested in...
The Conservative Party's victory in the UK general election means the Brexit withdrawal deal will be able to pass. The UK will leave the EU by 31 January and enter a transition period during which medicines regulation will remain broadly unchanged.
Health ministers have called for more action on access to medicines, including a new EU work agenda, rebuilding Europe’s manufacturing capabilities, further action on pricing, and greater leeway for member states to mitigate drug shortages by restricting parallel exports.