Technical gaps faced by Chinese generic medicine manufacturers to achieve the standards of WHO medicines Prequalification

Abstract

The study aims to determine the type and extent of technical gaps faced by Chinese generic medicine manufacturers to achieve the standards of WHO Medicines Prequalification. The study was undertaken with four manufacturers producing anti-tuberculosis Fixed Dose Combinations (FDCs) in China from March 2010 to June 2011 and with 47 manufacturers producing anti-HIV/AIDS, anti-tuberculosis, and anti-malaria medicines in China in August 2011. The study assessed key elements required to comply with WHO Good Manufacturing Practices and completion of regulatory dossiers. For Good Manufacturing Practices, the study found technical gaps in quality management, validation and qualification, and calibration and maintenance. More technical gaps were identified in risk management and correction action and prevention action. For dossiers, the study found three technical gaps: bioequivalence testing, incomplete information from active pharmaceutical ingredients suppliers, and stability testing. The study indicates the need for technical assistance to Chinese generic medicine manufacturers, particularly for dossier preparation but also that technical gaps are attributed to differences between the standards of Chinese drug regulations and of WHO Medicines Prequalification Program.