Asian Journal Of Social Pharmacy

Abstract: Objective To provide reference for relevant authorities in China to improve generic drug evaluation by comparing the background and methods of drug re-evaluation in foreign countries. Methods Comparative analysis method was used. Results and Conclusion Reasonable evaluation methods based on the experiences from foreign drug re-evaluation are put forward. It is suggested that the reference catalogue of pharmaceutical preparations and procurement platform should be established. Meanwhile the application process regulations and other measures should be perfected to better the consistency evaluation of generic drugs in China.

Key words: generic drug, consistency evaluation, reference preparation, dissolution curve, bioequivalence