Feb. 13, 2013
The European Medicines Agency (EMA) recently released a proposal for how it can help mitigate potential and real drug shortages stemming from manufacturing problems, reported FiercePharmaManufacturing. The six-page proposal notes that “Recent unexpected disruptions to the manufacturing supply chain due to manufacturing/GMP (good manufacturing practices) compliance problems have resulted in acute and chronic shortages of important medicinal products in the European Union (EU) requiring changes to prescribing information, and initiation of patient allocation programs.”
The Reflection Paper is concerned with public health crises that arise due to unforeseen disruptions within the manufacturing process, caused by manufacturing/GMP compliance problems and affecting medicinal products for human use, independent of their route of authorisation, where a need for co-ordination of the assessment and risk reducing actions at a Community level has been identified. Supply disruptions not caused by manufacturing/GMP compliance problems fall outside the scope of this Reflection Paper.
EU legislation currently requires mandatory pre-notification by Marketing Authorisation Holders (MAHs) of disruption of supply in the case of permanent or temporary cessations and for manufacturers of medicines in the case of any defect that could lead to an abnormal restriction in supply.
It will be interesting to see if the Food and Drug Administration (FDA) and the EMA work together on this proposal, perhaps by entering into a Memorandum of Understanding (MoU).
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