China – Experts suggest new method for assessing imported generic drugs in China

Population pharmaceutical quality assessment could be used to improve the quality consistency of generic drugs, suggests study.

According to researchers, a newly developed strategy could improve the quality of generic drugs by assessing process control and process risk. In addition to enhancing generic drug quality consistency, the approach could also serve as a basis for regulatory decision-making.

Generic medicines, the patent-expired versions of the branded drugs, contain the same active pharmaceutical ingredients (APIs) and serve the same indications as the branded ones, but are much cheaper. To be marketed, generic drugs must meet the same quality standards as their branded counterparts…