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Consistency evaluation how to keep up with BE test management

2020-06-17
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The pace of evaluation of the consistency and quality of generic drugs has gradually become clearer, and has become the hottest topic in the pharmaceutical industry over the past year. How to do consistency evaluation? Industry insiders are eagerly looking forward to the implementation of specific rules. At the same time, the results of the data verification have been published for three rounds, and the government’s determination and efforts to pay close attention to the quality and efficacy of drugs are more intense than in the past.
   Recently, the State Food and Drug Administration once again emphasized that the progress of consistency evaluation must not be delayed. It is also the focus of the current work of enterprises to carry out consistency evaluation as soon as possible. Among them, the issue of the management of bioequivalence (BE) trials has received great attention from representatives of the “two sessions” and corporate personnel. A person from a well-known CRO company told reporters that the current issue of low BE positivity in clinical trial institutions also troubles them.

   Insufficient quantity
  From December 1, 2015, the CFDA issued the “Announcement on the Implementation of Recording Management of Bioequivalence Testing of Chemical Drugs”, and the management of bioequivalence testing has entered a new stage. This is a great benefit for enterprises. The scope of filing does not distinguish between imported and domestic drugs, and promotes local pharmaceutical companies and foreign companies to stand on the same platform for registration. According to Circular 230 and Circular 231 issued in November 2015, in principle, companies should adopt in vivo bioequivalence test (BE) evaluation for generic drugs. In this way, the management of the BE test cannot be ignored in the consistency evaluation.
  An analysis pointed out that according to the CDE drug clinical trial registration and information disclosure platform, as of January 20, 2016, the total number of trials registered on the platform was 4,898. According to the total number of clinical trials registered annually (obtained CTR number), the number of clinical registrations of drugs in CDE has decreased year by year since 2014. Even if the BE system was released in December 2015, it has not been able to recover the downward trend in 2015.
“The serious shortage of BE test resources has become a key bottleneck restricting the development and consistency evaluation of domestic generic drugs in recent years.” Du Zhenxin, a representative of the National People’s Congress and chairman of Chenxin Pharmaceutical, also mentioned this in the motion submitted by the National “Two Sessions” One phenomenon. In 2015, CDE carried out a centralized review, and it is expected that nearly 1,000 drugs will be approved to carry out BE trial research before June 2016; from 2016, the change of the generic drug BE trial to the filing system will bring about a recent increase in direct demand; Among the nearly 170,000 drug approval numbers, there are 107,000 chemical drugs, more than 95% of which are generic drugs. Only the approval number of the basic drug oral preparation consistency evaluation task must be completed before the end of 2018. 20,000; According to the law of the company’s research and development of preparations, it is not easy to pass the BE test at one time. A process adjustment and optimization process is required. A project is likely to carry out BE test research multiple times.
At present, the number of GCP institutions qualified for BE research is only more than 100. In addition, the cost and risk of CFDA strict verification of clinical trial data have increased significantly. GCP’s enthusiasm for undertaking BE trial research has declined, and existing BE research resources cannot be completed significantly. Excessive research tasks.
At the same time, in the context of strict investigation of the current clinical trial data, the penalties for trial counterfeiters are increased. Although the price of the BE project is now significantly increased, the risk of the BE project is too high for clinical trial bases and CROs. Unwilling to start new projects easily. In the future, the clinical trial base and CRO will be more willing to do projects with higher quality and higher return.
“According to my understanding, there is indeed a phenomenon in which clinical trial institutions are not very enthusiastic about the consistent evaluation of the BE trial because of the high requirements and the high risks. Compared with the innovative drug research and development support, the income is not high, and it is indeed given to the entire Industry has an impact.” The CEO of a pharmaceutical company mentioned.
  Flexible management
   But what exactly should be done at the specific operational level? Some people in the industry said that some government officials came to ask if they could find the top experts to tell the company how to evaluate and how to do the BE test.
A CEO of a pharmaceutical company told reporters: “Some people who do bioequivalence research in large US companies have not yet determined whether domestic bioequivalence tests for consistency evaluation use international standards or look for Chinese characteristics. The standard is not known, so there is hesitation about whether to return to China.”
  Regarding the shortage of resources in key clinical trial institutions, Du Zhenxin believes that medical institutions that are not GCP certified but have the relevant conditions should be allowed to organize BE trials. The varieties and known dosages of BE test drugs that have been approved for marketing are safe and controllable, and the test technical specifications are very mature. Clinical institutions that have received professional training and supervision, and are not GCP certified, are fully equipped with the conditions and management capabilities for trial development. Allowing non-GCP certified medical institutions with relevant conditions to organize BE trials will play a positive role in reducing the management burden on GCP bases and alleviating the contradiction between supply and demand of BE trial resources.
   In addition, when the generic drug varieties declared in countries such as Europe, America, Japan and India are registered in China, if they are on the same production line and prescription process, they can share the BE test data developed abroad. Countries such as Europe, America, Japan, and India have high requirements for the authenticity, integrity, and standardization of generic drug BE test data, but the qualification requirements for test institutions are different from those in China. If a domestic pharmaceutical company has applied for a generic drug variety to a developed country, and at the same time has submitted a domestic application for registration, it is recommended that the BE test data carried out abroad be shared if the production line and prescription process are the same. In this way, it can not only reduce the burden of R&D investment, enhance the competitiveness of enterprises, increase the enthusiasm of domestic pharmaceutical companies to go abroad, but also save domestic BE test resources.
Some well-known enterprise R&D personnel mentioned to reporters, “In foreign countries, individuals or enterprises are allowed to set up laboratories that meet GCP requirements and undertake the corresponding research content, not necessarily qualified hospitals.” According to his understanding, there have been people who wanted to In order to get involved in this field, foreign-funded enterprises, domestic financial oligarchs, and large pharmaceutical companies may also enter in echelons in the future.
“Let the meeting bring risks, and policy formulation must be based on science to clarify the rules.” The CEO of a pharmaceutical company said, “For the problem of insufficient clinical institutions, you can consider flexible treatment, such as through relatively simplified certification, and then increase Some clinical trial institutions.”

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