EU To Kick Off ‘Joint Action’ On Tackling Drug Shortages
The joint action on ensuring security of medicines supply will be supported by the EU regulators’ shortages task force, which is to track efforts to coordinate member state activities on the supply and availability of medicines.
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A new EU regulation has come into effect, giving the European Medicines Agency wider powers to monitor, prevent and manage shortages of medicines and medical devices in public health emergencies. A number of steering groups and other bodies and networks are being set up to put the new systems into action.
Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances.
An explicit ban on patent linkage would ensure that competition to originator drugs is not delayed, according to off-patent industry group Medicines for Europe.