Abstract:
OBJECTIVE To investigate the current status and existing problems in quality and efficacy consistency evaluation of generic drugs, and to propose suggestions for facilitating generic drug consistency evaluation.
METHODS The product varieties, approval numbers held in manufacturers, publicity of reference products, as well as the problems identified in implementing generic drug consistency evaluation were summarized and analyzed for the oral solid dosage forms of the chemical generic drugs included in the National Essential Medicines List.
RESULTS The proportions of low-price and exclusive products involved in consistency evaluation remain relatively low, implicating that future accessibility risk was not negligible.
CONCLUSION The manufacturers are expected to assume their responsibilities in consistency evaluation and focus on quality improvement in their development; the competent regulatory authorities are expected to accelerate the issuance of incentive policies and measures, so as to facilitate generic drug consistency evaluation for the manufacturers.