EMA sets out stall on medicine shortages
pharmafile | December 11, 2012 | News story | Manufacturing and Production | EMA, GMP, shortages
The European Medicines Agency has called for action at the EU level to tackle the issue of medicine shortages caused by manufacturing disruption.
The agency issued a proposal document introducing various measures designed to avert cases where shortages have been caused by Good Manufacturing Practice (GMP) failures.
“Over the past two to three years there have been a number of public health crises caused by acute and chronic supply shortages as a result of manufacturing/GMP compliance problems”, says the EMA in its reflection paper.
An accompanying implementation plan details various short- and medium-term actions to minimise the risk of shortages, which the EMA attributes in part to the globalisation of manufacturing and supply chains.
Among the measures proposed is the development of a catalogue of centrally-authorised products (CAPs) and non-CAPs that have experienced shortages, which would be kept up-to-date with the help of voluntary communications by pharma companies.
It will also undertake a series of awareness-raising projects, starting in the second quarter of 2013 with a workshop to hear input from industry on how shortages can be averted.
The EMA document criticises the pharma industry for taking a ‘reactive rather than proactive’ approach to risk-management, adding that “sustained pressure is needed to bring about a change in a manufacturer’s approach to quality risk management and supply chain security”.
The agency also plans to develop tools to help it determine which shortages are critical and should be tackled at the EU level, as well as standard procedures for responding to emerging shortage situations.
Current shortages referred to in the paper include breast cancer drug doxorubicin, which was caused by the shutdown of a contract manufacturing facility operated by Ben Venue in the US.
The reflection paper was developed by the EMA in collaboration with the European medicines regulatory network, including the European Commission and regulatory authorities in EU member states.
Phil Taylor
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