The Opinions of the State Council on Reforming the Review and Approval System for Pharmaceuticals and Medical Devices (Guo Fa [2015] No. 44) divided drugs into two types: new drugs and generic drugs, and adjusted new drugs from the current "drugs that have not been marketed and sold in China" to "drugs that have not been marketed and sold inside or outside China". The current classification of new drugs is adjusted from "drugs that have not been marketed in China" to "drugs that have not been marketed outside of China", and the current classification of generic drugs is adjusted from "drugs that are imitated by existing national standards" to "drugs that are imitated by drugs of the same quality and efficacy as the original drugs". At present, the detailed new drug registration classification scheme is still in the pipeline, but the management department's re-adjustment of the drug classification will undoubtedly lead to the entry of three categories of drugs in the traditional classification into the generic category, which will have a huge impact on the registration and market development of such drugs. At a recent forum on "Writing with Intent" held in Guangzhou, experts expressed their concerns about the future of class 3 drugs.

Concern about the future of class 3 drugs

Compared with class 1.1 new drugs, domestic class 3 new drug development is becoming increasingly mature, as the risk and cost of developing class 3 new drugs is smaller than that of class 1.1 new drugs, so the domestic pharmaceutical industry in the development of class 3 new drugs and the rush to inject is also in full swing, competition is becoming increasingly fierce.

Apparently, policy adjustments have led to a quiet change in the registration game of "Class 3.1". Cheng Zengjiang, chairman of Beijing Kebayuan Biomedical Technology Co Ltd and founder of the same writing forum, said that in the past, based on the concept of protecting the national industry, the importation of new drugs was delayed as much as possible by means of "three reports and three approvals", but the orientation of the new policy has changed abruptly and the importation review is expected to be really speeded up. "The accessibility of clinical drugs in China has been prioritised, imported drugs have been approved at an accelerated pace, domestic class 3 drugs have become class 6, the original ones that did not get clinical approval have been directly withdrawn from review, and there is no chance of even doing class 3 drugs."

As a matter of fact, new class 3 drugs have a four-year monitoring period for new drugs, and the CDE no longer accepts registration applications for imported and domestic drugs before the expiry date, so the industry generally equates the "monitoring period" with the "patent protection period", and class 3 drugs therefore take into account As a result, the industry generally equates the "monitoring period" with the "patent protection period", and the three classes of drugs thus combine the titles of "first generic" and "new drug". However, this policy preference is also highly controversial within the pharmaceutical industry. "Will there be a monitoring period for Class 3 drugs if they become generics? If the monitoring period is abolished, will there be any meaningful monitoring period for Class 3 drugs that are already on the market? It will take time to observe the interface between the old and new system." Cheng Zengjiang speculated as such.

If the skin does not exist, the hair will not be attached. According to the logic of the newly released "No. 44" reform program, the classification of new drug registration for Class 3 drugs will be abolished in the future, and the monitoring period will naturally cease to exist. According to Wu Zhengyu, deputy director of registration at Eli Lilly and Company Suzhou Pharmaceutical Co Ltd, Class 3 drugs are neither an innovation nor a generic, and cannot exist in the long term. "What is unreasonable will be eliminated sooner or later, and robocopies are reasonable all over the world and must be done vigorously; in the future, people can still go for robocopies, but they may not get the special policies they used to get."

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