Minor Changes Still Burdensome to Report Under Revised Variations Regulation, European Industry and Competent Authorities Complain
By
Joanne S. Eglovitch / Email the Author / “The Gold Sheet” September 2009, Vol. 43, No. 009
Word Count: 2221 / Article # 08430091003
Executive Summary
Latest EU variations rewrite leaves both industry and regulators with concerns. Minor changes would still be difficult to implement and pre-notification requirements are seen as unworkable. A plan to subject all biologics changes to prior approval draws ire of biotech sector
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