19 drugs, thousands of approval numbers, this year or without consistency evaluation!

Source: Cypress blue 2018-01-31 19 drug, thousands of approval numbers, this year or without consistency evaluation! ▍ 19 on January 30, the drug evaluation center of the State Food and Drug Administration issued the notice on further improving the consistency evaluation of domestic unique varieties in 289 base drug catalog (hereinafter referred to as the notice) According to the notice, under the requirements of the General Administration's announcement on matters related to the conformity evaluation of quality and efficacy of generic drugs, the drug evaluation center combed the domestic unique varieties in the 289 catalogue and preliminarily formed a list of unique varieties (see Annex) 19 drugs are included in the list, and 1590 approval numbers are involved in all specifications Under the limited specification, there may be thousands of drugs in the specific drug category, which may involve hundreds of drug companies ▍ for special varieties, clinical trials should be carried out again In April 2017, in the announcement on issues related to the consistency evaluation of quality and efficacy of generic drugs issued by the General Administration, it was proposed for "domestic special varieties": At the option of the enterprise, the clinical trial can be carried out again to prove its safety and effectiveness, and the application shall be submitted in accordance with the requirements for application materials of conformity assessment of quality and efficacy of chemical generic oral solid preparations (Trial), and the conformity assessment shall be deemed to be passed after the subsequent review If the enterprise does not choose to carry out the clinical trial again, the State Administration of foreign affairs will announce that it lacks effective data and does not recommend the use of it ▍ state office: it can be extended to 2021 However, in the opinions on the consistency evaluation of quality and efficacy of generic drugs issued by the State Office in March 2016, it is indicated that among the drugs that need to complete the consistency evaluation by the end of 2018, the clinical effectiveness test and the varieties with special circumstances should be carried out, and the consistency evaluation should be completed by the end of 2021 Is it a little winding? No way To make this clear, we must quote large documents In fact, in the vernacular, the drug evaluation center has selected 19 unique varieties According to the requirements of the General Administration, these drugs must be re tested in clinical trials, otherwise they will not be used But before that, the state office said that the consistency evaluation of such drugs could be extended to 2021 ▍ do pharmaceutical companies do it or not? Look at these 19 drugs, most of them are general medicine and compound preparations Either there is no reference preparation, or there is little profit in the consistency evaluation of investment, resulting in hesitation According to the market feedback, for example, "berberine hydrochloride tablets" manufacturers, some are ready to give up In this time, it was listed into 19 unique varieties, and the good thing is that it can be extended to 2021, and clinical effectiveness test is inevitable It's just that there's a buffer in time, so it's still necessary to invest I don't know if the manufacturers of these general medicines will do it Attachment: 289 list of special varieties in China