[cro] how to find a suitable cro enterprise to entrust drug consistency evaluation?

Today, let's talk about the topic of generic drug consistency evaluation It's 13 months before the first batch of varieties to carry out the consistency evaluation (by the end of 2018) We hope that the consistency evaluation work has been completed in order If we are still hesitant to carry out this work, we hope to make a decision as soon as possible Consistency evaluation is both a challenge and an opportunity The implementation of the consistency evaluation policy makes pharmaceutical enterprises face great challenges, and pharmaceutical enterprises generally believe that this process is also an opportunity to reshuffle Review of generic drug conformity assessment policy According to the opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs (hereinafter referred to as the opinions) issued in March 2016, the conformity evaluation of chemical generic oral solid preparations approved for marketing before October 1, 2007 in the national essential drugs catalogue (2012 version) shall be completed by the end of 2018, in which the clinical effectiveness test and In case of special circumstances, the consistency evaluation shall be completed before the end of 2021; if the products are not completed within the time limit, they shall not be registered again At the same time, the above opinions encourage enterprises to carry out consistency evaluation, and the state will give policy support to medical insurance payment, centralized procurement and other aspects Medical institutions should give priority to procurement and clinical selection In addition, if there are more than three manufacturers that have passed the consistency evaluation for the same kind of drugs, the products that have failed the consistency evaluation will no longer be selected for centralized purchase of drugs Some professionals pointed out that those generic drugs that completed the consistency evaluation earlier and had a high degree of similarity with the original drugs will have obvious advantages in the market For the first batch of generic drug conformity assessment, the list of reference reagents with less time left for generic drug conformity assessment has been published in succession in 8 batches, which is only one year and one month away from a batch of generic drugs (289 varieties) to be completed by the end of 2018 If it cannot be completed on time, the approval number of the drug will be cancelled Because of this, many pharmaceutical companies in the first half of this year, the pressure increased rapidly, but a small number of enterprises are still waiting According to relevant policies and announcements, a complete "consistency evaluation workflow" is expected to take 440 days, about 14 months, from the selection and purchase of reference preparations to the completion of inspection, verification and technical review and approval Heavy task, tight time? How should pharmaceutical companies complete the consistency evaluation as soon as possible in the remaining more than one year? Looking for cro enterprises may be a good way How to find the right cro enterprise In terms of consistency evaluation cost, the single generic evaluation quotation entrusted by pharmaceutical enterprises to cro at present is about 5 million yuan, including 1-3 million yuan for pharmaceutical index comparative study and dissolution curve comparative study, 1-1.5 million yuan for bioequivalence test, and higher quotation for evaluation in Beijing, Shanghai and other cities; and because the generic drugs to be evaluated involve all aspects, it is consistent with The number of standard cro institutions is limited, so there is still room for prices to rise From the perspective of time and cost, how to find the right cro enterprises for consistency evaluation? It is another difficult problem for pharmaceutical enterprises Yaozhitong cro platform may be able to solve this problem well Yaozhitong cro is a cro aggregation service platform under yaozhi.com, which integrates cro resources and integrates cro companies and cro projects at home and abroad The platform project covers one-stop outsourcing services such as consistency evaluation, new drugs, clinical trials, application and project planning The platform relies on a large number of user base of yaozhi.com and big data analysis technology to realize multi-channel and all-round accurate promotion The Yao Zhitong cro platform supports the release of projects requiring consistency evaluation and other related projects, which are displayed on the front page of the platform for many cro related enterprises to see and wait for cro enterprises to find them automatically In addition to the above methods, we can also take the initiative to find a suitable cro enterprise on the platform according to our own needs The enterprises displayed on yaozhitong cro platform are only allowed to enter the platform after strict examination by the staff, so as to ensure the authenticity and effectiveness of enterprise information Do not need to search in the vast network, Shangyao Zhitong cro platform, you can easily find a suitable cro enterprise Click "view details" to learn about Yao Zhitong's cro activity information!