New Drug Classification Cited 3 Categories of Drug Imitation Change
Release time：2015-08-26
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The Opinions of the State Council on Reforming the Review and Approval System of Drugs and Medical Devices (No. 44 [2015] of the State Council) classifies drugs into two types: new drugs and generic drugs, and adjusts new drugs from the current "drugs that have not been marketed in China" to "drugs that have not been marketed in China", the generic drugs will be adjusted from the current "generic drugs with existing national standards" to "generic drugs with the same quality and efficacy as the original drugs". At present, the detailed new drug registration and classification supporting plan is still in the pipeline, but the management department's re-adjustment of drug classification this time will undoubtedly cause the three types of drugs in the traditional classification to enter the category of generic drugs, which will affect the registration and listing of such drugs. Market development has a huge impact. At the "Tongfreehand brushwork" forum held in Guangzhou recently, the participating experts expressed their concerns about the prospects of the three types of drug companies.
Focus on the Future of 3 Drugs
Compared with 1.1 categories of new drugs, the development of 3 categories of new drugs in China is becoming more and more mature. Because the development risk and cost of 3 categories of new drugs are smaller than those of 1.1 categories of new drugs, the domestic pharmaceutical industry is also full of power in the development and preemptive registration of 3 categories of new drugs, and the competition is becoming increasingly fierce.
Obviously, the adjustment of the policy level has led to the change of the registration game of "robbing the 3.1 class. Cheng Zengjiang, founder of the same freehand brushwork forum and chairman of Beijing Kebeiyuan Biomedical Technology Co., Ltd., said that in the past, based on the concept of protecting national industries, the import of new drugs was delayed as much as possible by means of "three reports and three batches". The orientation of the new policy has changed suddenly, and the import review is expected to be really accelerated. "The accessibility of clinical drugs in China has been given priority. The approval of imported drugs has been accelerated. The three types of drugs in China have been changed to six types. The original direct withdrawal of clinical approval documents has not even given the chance to make three types of drugs."
In fact, the three types of new drugs have a four-year new drug monitoring period, and CDE will no longer accept imported and domestic registration applications before the expiration date. Therefore, the industry generally equates the "monitoring period" with the "patent protection period". Therefore, the three types of drugs take into account the titles of "first imitation" and "new drug. However, this policy of preferential treatment is also highly controversial within the pharmaceutical industry. "If the three types of drugs become generic drugs, will the monitoring period be given? If the monitoring period is canceled, is the monitoring period of the three types of drugs already on the market still meaningful? The convergence of the old and new systems still needs time to observe." Cheng Zengjiang is such a guess.
If the skin is not there, the hair will be attached. According to the logic of the reform plan of the newly issued "Document 44", the registration classification of three types of new drugs will be completely canceled in the future, and the monitoring period will naturally cease to exist. Wu Zhengyu, deputy director of registration of Lilly Suzhou Pharmaceutical Co., Ltd., believes that the three types of drugs are neither an innovation nor a generic, and cannot exist for a long time and permanently. "Unreasonable things will be eliminated sooner or later, and imitation is reasonable all over the world, and it must be done vigorously. In the future, we can still imitate, but we may not get the special policies of the past."
Regarding the possible changes in the research and development of the three types of drugs, Lu Wenqi, director of the Guangdong Biomedical Innovation Technology Association, said frankly that the role of the monitoring period for the market is now very limited. Even for newly approved drugs in China, the monitoring period needs to be entered. The medical insurance catalog can only be released, but the medical insurance and bidding policies are now being adjusted, and the market is still watching. "Relying on the research and development of three types of drugs, it is still very difficult for enterprises to survive. Four or five or more than a dozen enterprises produce a variety of drugs, and finally bid for low prices. The market still cannot do it, and enterprises can only earn hard money. China's new drug research and development still needs to seek technological upgrading. New drug innovation often seems difficult, but it is not so difficult to persist in doing it. In the past, new drug research and development was fast and convenient, enterprises need to be patient. Whether they are making new drugs or generic drugs, they should practice their internal skills."
New Classification Tests Imitation Quality
After the class 3 drugs are changed from new drugs to generic drugs, their registration path will probably follow the bioequivalence test (BE) in accordance with the spirit of the new document, without the need for clinical trials. Previously, the relevant person in charge of the CFDA has pointed out that in vitro testing is the basis, and encourage in vivo testing. "In vitro dissolution test is done, and the dissolution curve is consistent with the original research. We regard it as equivalent in vivo. If there is no condition for dissolution in vivo, bioequivalence must be done. Bioequivalence is an important channel that can best prove that the drug is effective and ineffective and has equal curative effect."
In the exchange with the freehand forum, people in the industry also have their own views on this: on the one hand, some experts believe that the registration of generic drugs is likely to be further graded, and the requirements for clinical trials are still high for varieties with indications that may differ greatly from race and individual, while some varieties only need to be BE; on the other hand, the relationship between bioequivalence and dissolution curve is not directly equivalent. Cheng Zengjiang told reporters that the dissolution curve is different from BE, and BE is also different from clinical equivalence. "The requirements of BE for the three types of drugs may require the revision of the prescription and process. At this time, the enterprise is faced with two choices: whether to follow the method of regarding in vitro consistency as in vivo consistency, or to do BE directly in one step to the end, which requires the enterprise to weigh itself."
Wu Xiaoming, vice president of Anhui Xianfeng Pharmaceutical, further said that before the release of Document 44, great attention was paid to pharmaceutical equivalence. In fact, as long as impurities can be controlled and the four curves are consistent, there are still many choices in the process method, such as the selection of active agents and the control of the addition amount. However, the overall understanding of the industry needs to be further improved for individual medication, absorption and metabolism. "The dissolution curve is divided into several levels. First, it is tested according to the quality standard method. This is the dissolution of the first level. The dissolution method of the second level should have certain distinguishing power, but it is not necessarily related to the body. Although it is consistent, it is not necessarily equivalent. The third level is to find the dissolution curve of in vitro correlation, which cannot be done overnight, it is necessary to repeatedly re-evaluate and accumulate big data in vivo and in vitro. Japan and the United States are already trying to do this."
The Announcement on Soliciting Several Policy Opinions on Accelerating the Resolution of the Backlog of Drug Registration Applications (No. 140 of 2015) issued by the State Food and Drug Administration has made it clear that the review and approval of clinical trial applications should be optimized, and bioequivalence tests should be changed from the approval system to the filing system. The "BE filing system" undoubtedly provides technical support for Document 44, and while improving the speed of review and approval, it also strictly enpairs the requirements for the enterprise drug application and registration process and data management.
Xiao huifeng, director of phase I clinical department of Guangzhou boji pharmaceutical biotechnology co., ltd, pointed out that if the enterprise adjusts the scheme during the progress of BE test, it is suggested that the enterprise carry out pre-test. "The cost of bioequivalence test is rising very fast now, and the cost will continue to rise in the future. Pre-test can reduce risks, and it is not necessary to do equivalence after the pre-test is completed. However, some trends can be seen during pre-test. If the test preparation and reference preparation have obvious high-risk trends, the process can be adjusted in time or pharmaceutical research can be done to provide better samples, thus reducing risks."
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