EMA Taking Steps To Mitigate ‘Critical’ Product Shortages Due To GMP Problems
The EMA is consulting on changes to the template for declaring non-compliance with good manufacturing practice, as the first step in a revision of the procedures for handling GMP-related shortages of “critical” medicines.
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Medicine shortages are under scrutiny at national and EU level. In France, a newly established Senate task force is hearing evidence from a range of stakeholders including industry and regulators.
A survey of EU member states has shown wide variations in the way that they deal with shortages and discontinuation of medicines.
The French regulator has announced that it is importing supplies of Sandoz’ penicillin product benzathine benzylpenicillin as a result of shortages of the product. The French situation reflects a wider problem with supply of the product at the global level due to GMP issues and the shrinking number of API manufacturers.