Be test implements filing management to reduce the need for disorderly declaration

Source: the announcement on the filing management of bioequivalence test of chemical drugs (No 257, 2015) issued by the pharmaceutical economic news on December 4, 2015 was released on December 1 (late at night), a time node with unlimited reverie, and the opinions of the State Council on reforming the review and approval system of pharmaceutical and medical devices (GF [2015] 44) Compared with the announcement on several policies for drug registration review and approval (No 230 in 2015), it only started the implementation of drug regulatory policy reform Reducing the need for no disorderly declaration of be test from approval system to record management greatly shortens the time for drug registration applicants to obtain the permission to conduct be test and reduces the time cost for them to obtain drug approval documents, but compared with the previous, it certainly increases the technical difficulty of obtaining approval documents For regulators, reducing the need for disorderly declaration is not only conducive to improving work efficiency, but also to improving the quality of evaluation and access drugs In order to ensure that the whole process of be test is under control, the competent authorities at all levels have changed from the role of ex post judgment to the role of process participation, guidance and whole process supervision, with clear rights and responsibilities, solving the problem of regulatory timeliness and avoiding the accumulation of regulatory risks According to No 257 document, "the food and Drug Administration of each province (autonomous region, municipality directly under the central government) is responsible for the daily supervision and management of the be test conducted by the registration applicant and the drug clinical trial institution within its administrative region, and the verification of the authenticity and integrity of the be test data completed by the registration applicant." The regulatory responsibilities of the grass-roots Drug Administration for the specific implementation process are clarified; "the State Food and Drug Administration analyzes and evaluates the filing data of the registration applicant, and if there are obvious defects in the filing data and high risks in safety, the registration applicant shall be informed in time to terminate the be test In the process of technical review, the drug review center of the State Food and drug administration may put forward causal verification and sampling inspection for the filing data and the registration application related data after the completion of be test; if any problem is found in the authenticity, the application will not be approved.. " The right of the competent department to make final evaluation, judgment and decision on the research results, as well as the responsibilities of the competent department for risk assessment and control of the drug research process are clarified The pharmaceutical industry will always be a sunrise industry in the sunshine, and the pharmaceutical supervision needs more sunshine supervision The be test implements the filing system management, "the reference preparation of the registration applicant's be test and the basic information of each participant are open to the public" to accept the social supervision together, which increases the transparency of the drug registration review, works in the sunshine, and highlights the "openness, fairness and fairness" of the policy "If you don't have the diamond, don't do the porcelain work." In the era of approval system, as long as the drug registration applicant obtains the clinical approval of be license, the good days of getting the production approval will be gone To carry out be trial research, the first step is to put on record through the "drug clinical trial registration and information publicity platform", which mainly includes registration applicant information, product basic information, prescription technology, quality research and quality standards, reference preparation basic information, stability research, API, trial scheme design, ethics committee approval documents, etc ”Once these materials are submitted, they will form electronic files, and there is little chance to supplement or change them If it needs to be changed, the be test that has been carried out shall be terminated in time and an application shall be made, and the filing materials shall be submitted again Once the review finds that "there are obvious defects in the filing data and high risks in the safety", the applicant will be informed to terminate the be test in time As far as the applicant is concerned, there must be no uncertain battle The research before be test should not only be systematic and complete, but also be consulted and communicated with the supervision and review institutions before filing After confirming that there is no obvious technical defect, we will sign the be test contract with the "qualified drug clinical trial institution", and organize experts to discuss and formulate a detailed research plan The record number of be test has time limit requirements The information of subjects shall be submitted through the record platform in time If the information is not submitted within one year, it shall be explained If it is not submitted within two years, the original record number will automatically become invalid After the be test is completed, there is also a time limit for the submission of all research data The requirement that "the registration applicant shall submit the summary report or situation description of be test on the filing platform within one year after the completion or termination of be test for some reason" is actually the real-time monitoring of the research, which squeezes the time and space for the registration applicant to cheat and ensure the "authenticity, accuracy and traceability of the research data" The end of the be trial study is not the completion of the registration application Whether the drug registration application can be passed is based on the comprehensive review of all electronic filing materials and paper registration application materials submitted after the completion of be test research In view of the strength of the policy, it is suggested that the applicant must "be clear about the policy and never take chances" On the other hand, in the process of research, online monitoring from time to time improves the probability of successful drug registration of applicants The policy encourages the applicant to file the be test Before December 1, 2015, the application is still waiting in line Do you want to apply for registration or filing After December 1, 2015, please act in accordance with the regulations and put on record! According to the requirements of the filing scope of the annex, the full meaning generic drugs must be tested by be; for the products on the market that have quality risks and need to make auxiliary materials and process changes, it is better to use be test to prove the rationality; If the previous research is not perfect, and there is no evidence that the quality of the marketed products is consistent with the original research products or internationally recognized high-quality products, it should be proved by be test Of course, there are also special cases For some drugs with safety risks, or the be test can not completely replace the drugs that are clinically proven to be "effective and safe" or not for the purpose of domestic registration, be is required For the test, the policy is rigorous and very cautious It is recommended to follow the process of registration, application and approval in accordance with the relevant provisions of the measures for the administration of drug registration Is this announcement higher than the "measures for the administration of drug registration" in terms of technical operation, which makes the industry have more expectations for the introduction of the new "measures for the administration of drug registration" (including the definition of registration classification)