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Determination and acquisition of reference preparation

Time:2018-01-05 11:49:52

Announcement on issues related to the Evaluation of quality and Therapeutic effect of generic drugs > Policy interpretation 2017-9-20 issued by the State Administration of Drug Administration http://www.sfda.gov.cn/WS01/CL1757/177663.html The second of them II. What optimization measures are proposed in the Proclamation to identify and obtain reference formulations? In order to facilitate the enterprises to carry out research work, administration has issued the 8 batch of 610 varieties of different specifications of the reference preparation, including the general office of the State Council on the implementation of < < on generics quality consistency evaluation and effect of opinions, related matters announcement > (2016 No. 106th) to complete the generic conformance assessment shall be in the catalogue of varieties announced before the end of the <2018 (hereinafter referred to as the <289 catalogue >) in 163 varieties (219 gauge). The list of the other about 90 varieties of modified specifications, modified form, modified base varieties, according to < generics quality consistency and efficacy evaluation of change General considerations in the Evaluation of Standard drugs (Oral solid preparations). < Reformed drugs (Oral solid preparations) in the Evaluation of consistency of quality and Therapeutic effect of generic drugs. General considerations in evaluation of generic drugs and general considerations in evaluation of quality and efficacy of generic drugs. The above specifications, dosage forms, about 90 varieties of salt base reference preparation selection basis has also been clear. So far. Guidance has been given for the selection of reference preparations for most of the varieties in < 289 Variety catalogue. On the one hand, the selection sequence of reference preparations is further clarified. On the other hand, it is clear that the Bureau will continue to record the reference to enterprises. The preparation shall be selected and confirmed, and the reference preparation catalogue shall be issued in accordance with the requirements of the reference preparation. With regard to the acquisition of the reference preparation, the enterprise may declare a one-time import application and import record. Procedures such as customs clearance to obtain reference preparations, in addition, the announcement clearly enterprises can also through other ways to obtain reference preparations, in the submission of consistency evaluation information, only in the information to provide purchase vouchers. Materials such as product packaging and instructions, or other appropriate means to prove the authenticity of the reference preparation.