Implementing Minor Changes is Hard to Do Under Variations Regulation

By Joanne S. Eglovitch / Email the Author / “The Gold Sheet” January 2012, Vol. 46, No. 1
Word Count: 1159 / Article # 08120126004

Executive Summary

European generic drug makers say that it is difficult to implement Type IA changes under the variations regulation because of all the paperwork involved in submitting these changes to competent authorities. A 26 percent fee hike in filing variations is also making it more costly and difficult for manufacturers to justify making changes.

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Subjects
Manufacturing
Regulatory
Industries
Biopharmaceuticals
Regions
Europe

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