If you want to survive, you must conduct evidence-based medical research within the specified time to prove that the product is effective, otherwise you should quit decisively and focus on the superior product.

Recently, the State Food and Drug Administration's "Announcement on Several Policies for Drug Registration Review and Approval" (2015 No. 230), a heavy policy, was officially launched. Ten aspects, including approval and speeding up the approval of drugs in urgent clinical need, put forward clear requirements for drug registration review and approval. In terms of content, these measures embody the two core goals of the drug review 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 duplicate varieties, and achieve overall industrial upgrading.

As soon as the news came out, it quickly attracted widespread attention. "I think this interlocking combination of punches played by the state is conducive to further purifying the industrial environment, and making companies that do R&D down-to-earth and insist on doing a good job of medicine stand out." Distinguished expert of the national "Thousand Talents Program", Shanghai Medicilon Dr. Chen Chunlin, CEO of Biopharmaceutical Co., Ltd. told this reporter that clinical data fraud seriously affects the normal progress of drug review and approval, interferes with the scientific evaluation of the effectiveness and safety of marketed drugs, and innovation requires a standardized clinical research environment escort.

Create an innovative "quality ecosystem"

It is reported that in the future, the application for clinical trials of new drugs will be approved at one time, and the method of staged application and staged review and approval will no longer be adopted. It is worth noting that the state encourages the strengthening of communication between reviewers and applicants before and during the clinical trial application, so as to solve the problems in the registration application and clinical trial process in a timely manner.

"Document No. 230 involves issues that the industry urgently needs to solve, such as strengthening the communication between reviewers and applicants before and during clinical trial applications, which is conducive to improving the effectiveness of the review." Huazhong University of Science and Technology Tongji Medical College Drug Policy and Management Research Center Researcher Dr. Chen Hao pointed out that establishing a communication mechanism is a common practice abroad. It is not difficult to imagine that the review will become more and more strict in the future. If the company's prior communication is not sufficient or its understanding of the regulations is not comprehensive, it may lead to the "shooting" of varieties, causing great risks.

Dr. Gong Zhaolong, CEO of Sidi Pharmaceutical Technology Co., Ltd., said: "The intensive policies introduced during this period will have a very large impact on China in the next five or ten years, especially the encouragement of innovative drugs." He believes that the next step needs to be further Improve policy coordination. "This is the choice of the market, and I think the government's supervision will be more consistent with the market in the future."

The reporter noticed that there are eight varieties that will be eligible to line up alone. Circular 230 provides an accelerated approval channel for drugs that are urgently needed in clinical practice. Drugs for the prevention and treatment of AIDS, malignant tumors, major infectious diseases, rare diseases and other diseases, drugs for children, drugs for the elderly and multiple diseases can be applied for accelerated review. "Meeting clinical needs as the orientation can encourage market shortages and the R&D and production of innovative drugs." In the view of Lu Xianping, President of Shenzhen Microchip Biotechnology Co., Ltd., the important thing in the future is not how to change the dosage form to make 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 devotes more space to stipulating clinical data fraud. The accepted drug registration applications with major defects such as missing research materials, incomplete data, and incomplete prescription process tests are allowed to voluntarily withdraw. In general, the door to voluntary withdrawal will remain open for irregular, untrue, and incomplete data in drug clinical trials. exception.

At the same time as the announcement, the clinical trial data of 11 drug registration applications of 8 companies were announced by the CFDA that their registration applications were not approved due to unauthorized modification, concealment of data, and data untraceability. Chen Chunlin's company is engaged in drug research and development outsourcing services. He said: "The source of clinical data must be traceable, and suspected artificial fraud must be severely punished." However, he is also confused. If the data is incomplete during the research process, it is caused by unintentional omissions, etc. How should it be defined? "It would be better if a 'red line' could be drawn."

In addition, since December 1 this year, the bioequivalence test of generic drugs has been changed to the filing system. Xu Yong, executive vice president of the Pharmaceutical Research Institute of Renfu Pharmaceutical Group, said in an interview with reporters a few days ago: "BE filing is an important link that can speed up drug evaluation and improve industry self-discipline. The next comprehensive promotion will save a lot of generic drug applications. The time spent waiting in line for clinical approval will greatly improve the overall level of domestic generic drugs.”

Comprehensively enhance the "inner beauty" of medicines

Circular 230 stipulates that generic drugs are accepted, reviewed and approved according to the principle of consistency with the quality and efficacy of the original drug. The reporter noticed a detail, and classified treatment for generic drugs that have been accepted for review: the original research drug has been approved for marketing in China, and the generic drug applied for registration does not reach the same quality and efficacy as the original research drug. There is no original research drug approved for marketing in China. Enterprises applying for generic drug registration can choose to review and approve according to the original regulations. However, within 3 years after the drug is approved for marketing, it needs to conduct consistency evaluation according to the regulations. If the drug fails to pass the approval, it can also be withdrawn. The application for registration that has been declared shall be re-applied after it has been improved according to the standards consistent with the quality and efficacy of the original research drug. Priority review and approval will be implemented for the above-mentioned re-approved registration applications, and the quality and efficacy consistency evaluation will be exempted after approval for marketing.

At the same time, CFDA has implemented the centralized review of the same variety and the "Approval Catalogue of Restricted Drugs". "This is to guide the orderly research and development and rational declaration of enterprises." Xu Yong said that organizing forces to conduct centralized reviews according to unified review standards and scales is conducive to improving efficiency. Through the consistency evaluation, there will be a batch of drugs that must be withdrawn from the market because they fail to meet the requirements.

Quantity is only an appearance. 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 state of multiple listings and disorderly competition, and to avoid waste and bad money driving out good money. R&D personnel are no longer encouraged to invest in production for inferior varieties."

More importantly, the competent authorities have a clear attitude towards situations where risks exist. If there is evidence that the drug is inaccurate in efficacy or has serious adverse reactions, the drug approval will be revoked immediately; Re-evaluation, and submit the re-evaluation results to CFDA within 3 years, and the approval of drugs that fail to pass the re-evaluation will be withdrawn.

"Compound varieties of traditional Chinese medicines, nutritional medicines, and auxiliary medicines approved according to chemical medicines, especially some medicines with low quality level, will be eliminated in the rule of survival of the fittest." During the interview, experts and business people have the same opinion, even if there is a three-year buffer period, it is also very difficult. If you want to survive, you must conduct evidence-based medical research using modern medical research methods within the specified time to prove that the product is effective. Otherwise, you should withdraw decisively and focus on superior products.

(Jilin Province Qijian Biotechnology Co., Ltd. www.qjbio.com.cn)