What is the core standard for judging the value of new drugs?
If you want to survive, you must conduct evidence-based medical research within the prescribed time to prove that the product is effective. Otherwise, you should decisively withdraw and focus on the superior products.
Recently, the State Food and Drug Administration's "Notice on Certain Policies for the Examination and Approval of Drug Registration" (No. 230 of 2015) was officially hanged on the net, from improving the approval standards for generic drugs and optimizing the evaluation of clinical trial applications. Ten aspects, such as approving and accelerating the examination and approval of drugs such as urgent clinical needs, have made clear requirements for drug registration review and approval. From the content point of view, these measures embodies the two core objectives of the drug reform: one is to encourage independent innovation by improving the quality of drugs; the other is to vigorously improve the level of generic drugs, eliminate low-level repetitive varieties, and achieve overall industrial upgrading.
The news broke out and quickly caused widespread concern. "I believe that this interlocking combination of punches by the state is conducive to further purifying the industrial environment, allowing enterprises that are doing research and development and sticking to good medicines to stand out." National "Thousand Talents Program" special experts, Shanghai Medicilon Dr. Chen Chunlin, CEO of Biomedical Co., Ltd. told this reporter that clinical data fraud seriously affects the normal conduct of drug review and approval, and interferes with the scientific and effective evaluation of the effective safety of listed drugs. Innovation requires a standardized clinical research environment.
Create an innovative “quality ecosystem”
It is reported that in the future, the clinical trial application of new drugs will be approved once, and the method of instalment declaration and instalment review and approval will no longer be adopted. It is worth noting that the state encourages the communication between the reviewers and applicants before and during the clinical trial application, and solves the problems in the registration application and clinical trial process in a timely manner.
“No. 230 document addresses the urgent needs of the industry, such as strengthening the communication between the reviewers and the applicants before and during the clinical trial application, which is beneficial to the review and improvement.” Center for Drug Policy and Management, Tongji Medical College, Huazhong University of Science and Technology Researcher Dr. Chen Yu pointed out that establishing a communication mechanism is a common practice abroad. It is not difficult to imagine that the future review will be more and more strict. If the company's prior communication is not sufficient or the regulations are not comprehensive, it may lead to the "shot" of the variety, posing a great risk.
Dr. Gong Zhaolong, CEO of Ideas Medical Technology Co., Ltd. said: “The policy of intensive introduction during this period will have a very big impact on China's future five years and even ten years, especially the encouragement of innovative drugs.” He believes that further needs to be further Improve the coordination of policies. "This is the choice of the market. I think the government's supervision will be more consistent with the market in the future."
The reporter noted that there are eight major varieties will enjoy the qualification to stand alone. Circular 230 provides an accelerated approval channel for clinically urgently needed drugs. Drugs for the prevention and treatment of AIDS, malignant tumors, major infectious diseases and rare diseases, children's medications, elderly-specific and multiple-dose medications may be submitted for expedited review. "To meet clinical needs, it can encourage market shortages and R&D and production of innovative drugs." In the view of Lu Xianping, president of Shenzhen Microcore Biotechnology Co., Ltd., the important thing in the future is not how to change the dosage form to do new drugs, but should pay attention to it from beginning to end. Meeting clinical needs is the core criterion for judging the value of a new drug.
Circular 230 also uses more space to regulate clinical data fraud. Applicants for registration of drugs that have accepted major defects such as missing research data, incomplete data, and incomplete prescription process tests are allowed to withdraw actively. In general, the data that is not standardized, untrue, and incomplete in the clinical trials of drugs, the door that allows active revocation will still be opened, but will be severely punished if there are problems found in the application submitted after the completion of the self-examination, no exception.
At the same time as the announcement, the clinical trial data of 11 drug registration applications of 8 companies were not authorized due to unauthorized modification, data reporting and data non-traceability. Chen Chunlin's company is engaged in drug R&D outsourcing services. He said: "The clinical data source should be traceable. It is suspected that human beings must be severely punished for fraud." However, he is also confused. If the data is incomplete during the research process, it is caused by unintentional omissions. How should it be defined? "It would be better if you could draw a 'red line'."
In addition, since December 1 this year, the generic bioequivalence test has been changed to the filing system. Xu Yong, executive vice president of Renfu Pharmaceutical Group Medical Research Institute, said in an interview: “BE filing is an important part of accelerating drug review and improving industry self-discipline. The next comprehensive promotion will save a lot of generic drug applications. The waiting time for clinical approvals will increase the overall level of domestic generic drugs."
Comprehensively enhance the "inner beauty" of drugs
Circular 230 stipulates that generic drugs are accepted and reviewed and approved according to the principle of consistency with the quality and efficacy of the original drug. The reporter noticed a detail on the classification of the acceptance of the generic drug review: the original drug has been approved for listing in the territory, and the generic drug applied for registration has not reached the approval of the original drug quality and efficacy; it has been listed outside China. There is no approved original drug in the territory, and enterprises applying for generic drug registration may choose to conduct the review and approval according to the original regulations. However, within three years after the drug is approved for listing, it is necessary to conduct the conformity evaluation according to the regulations, and the unapproved drug approval certificate; the enterprise may also withdraw. The declared application for registration shall be re-declared after being improved according to the standards consistent with the quality and efficacy of the original research drug. The above-mentioned re-declared registration application will be subject to priority review and approval, and will be exempted from quality and efficacy consistency evaluation after approval.
At the same time, CFDA passed the centralized review of the same varieties and the Catalogue of Selected Drug Approvals. "This is to guide the orderly research and development and rational declaration of enterprises." Xu Yong said that centralized evaluation according to unified evaluation standards and scales will help improve efficiency. Through the consistency evaluation, there will be a batch of drugs that must be delisted because they do not meet the requirements.
The quantity is only an appearance, and the deeper meaning is that the structure of drug research and development is more reasonable. Some experts in the interview said: "This is mainly to avoid the status of multiple listings and disorderly competition, to avoid waste and bad money to drive out good money. For low-grade varieties, R&D personnel are no longer encouraged to invest in production."
More importantly, the competent authorities have a clear attitude towards the existence of risks. Any evidence that the efficacy of the drug is inaccurate and adverse reactions are harmful to human health, immediately withdraw the drug approval; relevant production enterprises should promptly carry out related products. Evaluation, and submitted the re-evaluation results to CFDA within 3 years, and failed to approve the withdrawal of the drug approval.
"Chinese medicine compound varieties, nutritional drugs, and auxiliary drugs approved according to chemical drugs, especially those with low quality levels, will be eliminated in the rules of survival of the fittest." In the interview, experts and business people agree that even if there are three years of buffering The period is also very difficult. In order to survive, it is necessary to conduct evidence-based medicine research using modern medical research methods within the prescribed time period to prove that the product is effective, otherwise it should decisively withdraw and focus on the superior products.
(Jilin Qijian Biotechnology Co., Ltd. www.qjbio.com.cn)