EU Eyes Revamp Of Policy To Speed Drug Approvals In Developing Countries

Article 58, a process introduced by the European Commission to help speed up the time low and middle-income countries take to approve new drugs, could be in for a massive overhaul. A revamp has been proposed because it is underused - just a handful of products have gone through the Article 58 process since its launch in 2004. The most recent is an antiseptic chlorhexidine gel that prevents new-born umbilical cord infections in developing countries. A joint project between GSK and Save the Children, it was approved late last month.








