Difficulties and troughs in the implementation of conformity assessment

Source: Xinkangjie 2016-04-18 small and medium-sized enterprises can't afford Xianda data v3.2 collate 219 corresponding enterprise discoveries of oral basic medicine products that must be completed before 2018 (see the table below) Shanghai Xinyi, China Resources Shuanghe, Baiyunshan, Shiyao and other enterprises are under great pressure In 2015, the profit of Cr double crane was RMB 661 million If a product budget of RMB 5 million is used, the consistency evaluation of 130 base drug products can be done, and the number of consistency evaluation products needed by CR double crane can be basically completed But for unlisted small and medium-sized enterprises, one year's profit is less than 30 million yuan, and one year's profit is just as good as six products Moreover, the investment of 5 million yuan may not guarantee to pass the consistency evaluation, so the attitude of SMEs towards the consistency evaluation is more wait-and-see The number of top 20 enterprises that must complete the consistency evaluation of basic drug oral drug products by 2018 is the difficulty of the implementation of the consistency evaluation 1 The legality of the reference reagent First of all, which is the original manufacturer of the reference reagent, whether it is listed in the United States, the European Union, Japan and other countries, can it still purchase relevant original research drugs, if not, whether high-quality generic drugs are still on the market? The above information collection has been difficult for many R & D personnel Secondly, the process of one-time import of reference reagents seems to be still under exploration, that is to say, even if we know which one is the target research object, the country is not ready to release it The biggest difficulty lies in the clinical trials, which need to provide the quality standards of the original research drugs or internationally recognized generic drugs It's learned that no one can break this big move Maybe the enterprise should first do a good job of CMC data, maybe it will be able to do be clinical, the original research and development have completed the consistency evaluation, and can implement the "take doctrine" 2 Be base is in short supply, be base is in short supply and the cost is more and more expensive For the base drug, which is difficult to bring benefits to researchers, the willingness of researchers to cooperate is not so high However, the be base is already limited, and it is inevitable that the cost will increase even more Moreover, since the initiative of the project is in the clinical base, and the service quality provided by the clinical base is not significantly improved, then CMC is well done, and the process is improved If it is planted in the clinic, it is difficult to trace back which aspect is not well done 3 The evaluation of R & D outsourcing dilemma consistency is not equal to the previous domestic 3.1 generic application At present, the R & D team of most domestic enterprises is not competent, only the R & D team that has participated in the application of generic drugs in the United States, the European Union and Japan and has relatively rich experience This means that most enterprises have to choose outsourcing, and the outsourcing team can not guarantee the exclusiveness of the project For domestic enterprises, the cost is only to raise the threshold, but it can not guarantee the exclusive position in the consistent competition.