US, Switzerland Sign MRA Recognizing Each Other's Pharmaceutical Inspections
FDA on Jan. 12 signed a Mutual Recognition Agreement with Switzerland’s Agency for Therapeutic Products (Swissmedic) that will allow the U.S. and Switzerland to rely on each other’s inspections of pharmaceutical and veterinary drug facilities, avoiding the need for duplicate…
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inspections, FDA said in a statement that day. Prior to the MRA’s entry into force, FDA still must “determine whether Swissmedic is capable of conducting inspections that meet U.S. requirements, and Swissmedic must make a similar determination with respect to the FDA meeting Swiss requirements,” FDA said. The MRA includes privisons on when the regulators intend to accept official good manufacturing practice documents from the other; how regulators will transmit the documents; and the establishment of two committees “to facilitate the effective functioning of the MRA,” said a release from the Office of the U.S. Trade Representative, which also signed the agreement.