Make up a missed lesson-New policy to ensure the interchangeability of generic drugs in China

Abstract

Generic drugs should be interchangeable with originators in terms of quality and efficacy. With relative lower prices, generic drugs are playing an important role in controlling health expenditures and ensuring access. However, the widespread understanding of "cheap price equals low quality" has a negative impact on the acceptance of generic drugs. In China, medical doctors doubt the efficacy and quality of generic drugs manufactured domestically. To address these concerns, the Chinese State Council released a policy in 2016 to ensure the interchangeability by re-evaluating the quality and efficacy of generic drugs. It intends to make up a missed lesson in the regulation to be in line with internationally accepted practices. Generic drugs firms, depends on the availability of appropriate comparators, should conduct either comparative bioequivalence studies or full scale clinical trials. The re-evaluation will be implemented in a stepwise approach with the essential medicines covered in the first step. The policy could achieve several benefits by increasing confidence on the Chinese produced generic drugs, upgrading regulatory standards, streamlining the Chinese generic drug industry and creating a healthy competition market. Nevertheless, enormous challenges remain in enlarging the capacity to review applications, selecting appropriate comparators, ensuring the capacity of domestic clinical research sites, and achieving the acceptance of re-evaluated generic drugs.

Keywords: Bioequivalence studies; clinical trial; comparators; drug regulation; efficacy; essential medicines; generic drugs; generic drugs industry; interchangeability; quality; re‐evaluation.