The first batch of priority review and approval of 5 children's drug registration applications officially announced! The basic principles of assessment have been determined

Source: CFDA drug review center issued the announcement on the basic principles of evaluation and approval of drug application priority and the first batch of priority evaluation varieties for children in clinical urgent need on January 29, 2016 According to the announcement, the basic principles for the evaluation of the varieties of children's drug application for priority review and approval in clinical urgent need organized by the drug evaluation center and the catalogue of children's drug registration application varieties for priority review and approval were publicly solicited and improved from December 21-28, 2015, and approved by the State Food and drug administration The identified priority review and approval varieties will be included in the priority review of the review plan The basic principles of the evaluation of the drugs for children in urgent need are as follows: 1 The principles are applicable to the evaluation of the drugs for children in urgent need 2、 Basic principle (1) new varieties for children: such varieties shall meet any of the following conditions 1 For the diseases that seriously threaten children's lives or affect children's growth and development, and there is no effective treatment drugs or treatment means at present; 2 Compared with the existing treatment drugs, it has obvious treatment advantages （2） Change dosage form or add new specification varieties: these varieties shall meet the following two conditions at the same time 1 The current domestic drug instructions contain the "dosage for children"; 2 The existing dosage forms or specifications are not suitable for children, and the new dosage forms or specifications are suitable for children （3） Imitated varieties: priority should be given to the evaluation of children's medicines which are in short supply in the current market If the number of manufacturers applying for the above-mentioned (2) and (3) varieties is more than one, the first priority shall be evaluated according to the order of application queuing If the evaluation fails to meet the requirements, the priority qualification shall be cancelled, and the following applications for the same varieties can be supplemented and replaced in order.