Chinese FDA to Launch a Quality Consistency Evaluation for Generic Drugs

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Chinese State Food and Drug Administration (“SFDA”) issued a draft Work Plan for Quality Consistency Evaluation for Generic Drugs (“Work Plan”) on November 22 for public comments through December 6. As part of the 12th Five-Year Plan for Drug Safety, the Work Plan aims at elimination of generic drugs which fail the quality consistency evaluation in order to enhance the overall quality standards of generic drugs.

The Quality Consistency Evaluation will focus on consistency of composition and clinical efficacy between the test and reference products. SFDA intends to pilot the Quality Consistency Evaluation on the solid oral dosage forms of essential drugs which have been applied widely in the patient population, with a large sales volume, produced by multiple manufacturers and that can be compared to a specific reference product.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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