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FDAnews Drug Daily Bulletin
Aug. 17, 2012 | Vol. 9 No. 162
PIC/S, EMA Agree to Harmonize Drug GMPs to Bolster Data Trades
The international Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the European Medicines Agency (EMA) are harmonizing their good manufacturing process (GMP) guides for drugs to ease the flow of shared inspection data. The two entities agreed to merge their respective GMP guides and related documents in a recent addendum to their two-year cooperation compact. That accord expires at the end of this year and the pair said they may renew the agreement after assessing their efforts.
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