Lessons learnt from providing technical assistance to Chinese generic medicines manufactures to achieve the WHO Prequalification standards

Abstract

The World Health Organization (WHO) Prequalification sets a benchmark of generic medicines quality standards for both local utilization and international procurement. So far in China, there are only 35 medicines prequalified by WHO among around 400 eligible products. With a large volume of generic medicines production capacity, WHO has been paying great attention to Chinese firms by providing technical assistance to achieve WHO Prequalification standards. In 2009–2011, Bill and Melinda Gates Foundation sponsored a project to scale up tuberculosis control in China. The adoption of anti-tuberculosis medicines in fixed dose combinations form was selected as an important intervention tool. In order to have quality assured anti-tuberculosis medicines available, four Chinese anti-tuberculosis generic manufacturers were selected for technical assistance as a pilot. The maturity of each generic manufacturers to achieve WHO standards was used to evaluate the role of WHO’s technical assistance. The maturity was measured from the perspective of production and dossier. The WHO’s technical assistance contributes to the maturity of manufacturers. In production, it increased from an average of 53% to 80% for quality management system, and 70% to 80% for good manufacturing practices; in regulatory dossier, it increased from 28% to 67% for quality part, and 0% to 75% for efficacy and safety part. It also found out the factors having impact on the effect of technical assistance. The sustainability of technical interventions was influenced by guaranteed market share and support of two key partners: active pharmaceutical ingredients producers and clinical research organizations. The pressure of upgraded national drug regulatory standards has an impact on the effect of technical assistance.