Regulatory Roundup for the Week of March 25, 2013

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FDA's Commissioner discusses pharmacy compounding, EMA updates guidance

FDA Commissioner Margaret Hamburg, M.D., calls for legislation for oversight of pharmacy compounders. “…our authorities are limited and not the right fit for FDA to provide appropriate and efficient oversight of this growing industry. There should be legislation that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate.  FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations.  Even during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting,” Hamburg says on FDA’s website.

The European Medicines Agency (EMA) is increasing fees paid by applicants and marketing-authorization holders 2.6%. The annual increase goes into affect April 1, 2013 and all applications received after March 31, 2013 will be charged the adjusted fees.


EMA has revised its procedural guidance for pharmaceutical companies to include the latest information related to new pharmacovigilance legislation. The revised guidance discusses pre- and post-authorization procedures. There are also specific sections for generic, hybrid, and biosimilar medicines.