EU grants U.S. API makers exemption from certification rule

The FDA has gotten the coveted waiver from the European Commission from its new rules for imported APIs less than two weeks before the rule is set to go into effect on July 2. It means that APIs manufactured in the U.S. and shipped to Europe will not have to also provide certification from the FDA that they meet EU manufacturing standards. The U.S. joins Switzerland, Japan and Australia in being exempted from the requirement to provide written proof of standards. Release | More

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