On January 24th, an online article "A large number of similar data in the consistency evaluation of generic drugs" caused a heated discussion. The author gave three varieties as examples, such as rosuvastatin calcium tablets, where the bioequivalence test data of the two production enterprises, Nanjing Chia Tai Tianqing and Lek Pharmaceuticals d.d, were completely the same; among the 6 generic drugs that passed the consistency evaluation of trametazidine hydrochloride tablets, the data of Hubei Sihuan and Grand Pharma also appeared to be the same; and the BE fasting data of metformin hydrochloride tablets of Guizhou Tian'an Pharmaceutical was consistent with the data of Shanghai Shangyao Xinyi Pharmaceutical Factory.

The author also stated in the article that it is very difficult and requires very high standards for a generic drug to pass the consistency evaluation formally. There are tens of thousands of generic drugs in our country, and only 1,988 specifications have passed the consistency evaluation so far. In addition to passing the quality standard tests in the laboratory, it is also necessary to verify its bioequivalence in human trials. And these verification methods and processes are basically international common practices regardless of the United States or Japan.

That afternoon, the Drug Evaluation Center of the National Medical Products Administration released a "Correction Explanation" on its official website, stating that "After verification, it was due to editorial errors when disclosing relevant product information in 2019 and 2021 that led to the above problems. The center has corrected the wrong information on the website in the first place."

Source: https://finance.eastmoney.com/a/202501243307871784.html