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Article: EU con on RO for injectables; harmonization efforts fail.(Brief Article)
- Article from:
- Validation Times
- Article date:
- April 1, 1999
- Author:
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One of the U.K.'s top drug regulators told an industry conference April 12 that the European Union prefers distilled water in drug production to reverse osmosis (RO) systems and that harmonization of U.S. and European requirements is not going to happen.
Dr. Andrew French, Ph.D., principal pharmaceutical assessor in the New Chemical Entities Group of Britain's Medicines Control Agency, told the International Business Communications' meeting in Washington: "The word used should be 'concordance' because we will never reach harmonization."
French noted the European Pharmacopoeia (EP) takes precedence over national compendia but some EU members have said ...