Jiangsu Province will cancel the approval document if it fails to pass the consistency evaluation in the clean-up of the generic drug market

According to the seminar on encouraging innovation and ensuring the supply of generic drugs held in Nanjing on May 5, our province will intensify efforts to eliminate generic drugs with low quality, high repetition rate and failing to pass the consistency evaluation, so that people can use more generic drugs with high quality and low price The patented drugs are called "original research drugs" After the patent expires, other pharmaceutical companies can legally produce generic drugs However, dozens of pharmaceutical companies often flock to them, and the research on the prescription ingredients of the original drugs is insufficient or the production process is not qualified, resulting in uneven efficacy Wang Zongmin, director of the drug registration and Administration Department of the provincial food and drug administration, said that in order to expel the generic drugs with poor efficacy from the market, the state requires that 289 generic drugs included in the list of basic drugs be evaluated for quality consistency before the end of the year, and the generic drugs that fail to pass the evaluation will be cancelled the approval number By the end of October, our province had carried out consistency evaluation on 451 drugs for oral solid preparations, involving 254 varieties of 93 enterprises, completed the research and accepted 62 product specifications, ranking first in the country in terms of quantity; 16 were approved, ranking second in the country in terms of quantity At present, the generic drugs that pass the consistency evaluation are marked with the mark of "consistency evaluation of generic drugs" on the drug box According to relevant policies, high-quality and low-cost generic drugs will enjoy more preferential policies in drug catalog adjustment, medical insurance reimbursement policies, etc., while generic drugs that fail to pass the consistency evaluation will not be able to enter the unified procurement platform and the hospital.