The
European Commission, the FDA, and the European Medicines Agency (EMA) have
signed a new confidentiality agreement that allows regulators on both sides of
the Atlantic to share non-public and commercially confidential information,
including trade secrets about inspections.
The
new agreement formally recognizes that FDA's EU counterparts have the authority
and demonstrated ability to protect the relevant information, according to the
EMA statement.
Posted by Dr. Tim Sandle
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