Release of technical guidelines for research of paclitaxel (albumin binding) generic drugs for injection

On January 8, CDE official website released the notice on "technical guidelines for research on generic drugs of paclitaxel for injection (albumin binding type)" (Draft for comments) According to the notice, in order to implement the opinions of the State Council on reforming the review and approval system of pharmaceutical and medical devices (GF [2015] No.44), the opinions of the general office of the State Council on carrying out the consistency evaluation of the quality and efficacy of generic drugs (GBF [2016] No.8), the opinions of the general office of the State Council on deepening the reform of the review and approval system to encourage the innovation of pharmaceutical and medical devices (Ting Zi [2017] No.42) ）With the relevant requirements of the State Administration and the drug Audit Center on the chemical generic drugs, the research ideas and technical requirements of the special injection chemical generic drugs were clarified, and the applicant was served to carry out relevant research work for specific varieties After extensive investigation and discussion with experts and the industry, CDE organized and drafted the technical guidelines for the research of Taxol (albumin binding) generic drugs for injection 》(Draft for comments) We are now open to the public for comments within one month from the date of publication Please send your feedback to the email address of the following contact Contact person: Zhang Junlin, Na Xinzhu Email: zhangjl@cde.org.cn, naxzh@cde.org.cn Thank you for your participation and support Drug Evaluation Center January 8, 2020 Attachment: