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The European Medicines Agency has published a plan to help Europe?s regulatory network prevent, mitigate and manage shortages of important medicines following manufacturing problems.
The European Medicines Agency has published a plan to help Europe’s regulatory network prevent, mitigate, and manage shortages of important medicines following manufacturing problems.
Shortages of medicines arising from unforeseen disruptions within manufacturing processes, such as GMP compliance issues, have increased in recent years. However, experience from these shortages has enabled the EMA to identify several short- and medium-term actions that will help to deal with future occurrences. These actions are outlined in the EMA’s reflection paper on medicinal product supply shortages caused by manufacturing/Good Manufacturing Practice Compliance problems.
Some of the actions being taken in the short term include, among others:
In the medium term, the EMA hopes to:
According to EMA, several trends have converged to increase the number of medicines’ shortage. One of the major contributing factors is the globalization of supply chains and manufacturing networks.