The general office of the General Administration of the people's Republic of China solicits opinions on the procedures for the conformity assessment of the quality and efficacy of generic drugs and the requirements for the application materials for the conformity assessment of chemical generic oral solid preparations

Source: CFDA 2016-3-29 in accordance with the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44) and the notice of the general office of the State Council on the evaluation of the quality and efficacy of generic drugs (GF [2016] No 8) No.), the food and drug administration has formulated the procedures for conformity assessment of quality and efficacy of generic drugs (Draft for comments), and the requirements for application materials for conformity assessment of oral solid preparations of generic drugs (Draft for comments) (including the summary of research data information and requirements for application materials writing) Now, it is open to all provincial food and drug administration departments and all sectors of society for opinions Please feed back the modification opinions to the quality conformity evaluation office of generic drugs of the State Food and drug administration by email before April 20, 2016 Email: fzy@nifdc.org.cn attachment: 1 Procedures for conformity assessment of quality and efficacy of generic drugs (Draft for comments) 2 Requirements for application materials for conformity assessment of chemical generic oral solid preparations (Draft for comments) General Office of food and Drug Administration attachment 1, March 28, 2016 : procedures for conformity assessment of quality and efficacy of generic drugs (Draft for comments) Doc Annex 2: requirements for application materials for conformity assessment of chemical generic oral solid preparations (Draft for comments) Doc