The application and analysis of the import registration of the original research drug

Author: Since the implementation of the consistency evaluation policy, the original research drug has attracted much attention In the guiding principles for the selection and determination of reference preparations for general oral solid preparations, it is clearly stated that "reference preparations refer to the reference drugs used for the consistency evaluation of quality and efficacy of generic drugs, which are usually the objects to be copied, such as the original research drug or internationally recognized drug of the same kind", that is to say, the original research drug is the reference drug Preparation, so the original research drug is very important in the development of generic drugs, to a large extent determines the development direction of generic drugs In the work plan for the reform of chemical drug registration and classification published by the state on March 4, 2016, the declaration information of the original research drug was summarized into category 5.1, and the analysis of category 5.1 declaration was of great significance for the development of generic drugs According to insight database information, up to now (November 15, 2019), CDE has accepted a total of 550 category 5.1 import registration acceptance numbers Based on the year of declaration, the details are as follows: From the above data, we can see that the number of registered acceptance numbers of original research in China is increasing every year, especially in 2019, there are more than 200 acceptance numbers, which is enough to see that original research enterprises pay more and more attention to the Chinese market Among the 550 import registration acceptance numbers that have been declared, 206 original research enterprises are involved, among which the top 10 original research enterprises in terms of import varieties (calculated according to the acceptance number) are as follows, and Novartis Pharmaceutical Co., Ltd temporarily ranks first with 56 It can be seen from the above table that the original research drug companies that have entered China at present include Pfizer, Novartis, AstraZeneca, Gilead and other major international companies, among which the total number of application acceptance numbers of the above ten enterprises has reached 279, accounting for about half of the total number of applications To a large extent, the active ingredient of the original research drug is a brand-new molecule, which is unique in clinical efficacy Different treatment fields have different degrees of attention at home and abroad Understanding the distribution of the original research drug in the treatment field has a good reference significance for the project establishment of the enterprise The statistics of the original research drug in the treatment field are as follows: From the analysis of the above results, at present, the original drugs are mainly focused on tumor drugs and nervous system drugs In recent years, tumor has become one of the major lethal diseases at home and abroad Because of its complex etiology, diversified tumor cell variation, and no specific drugs have appeared in the world, drugs in this field have become the hottest research and development field Compared with domestic, foreign countries started early and the system is more perfect There are more anti-tumor drugs on the market, and the treatment is more diversified and reasonable With the continuous rise of domestic economic level and the expansion of drug market, a large number of anti-tumor drugs enter the medical insurance, attracting foreign enterprises to continuously put anti-tumor drugs into the domestic market At present, neuralgia drugs are also a hot area of research and development at home and abroad, including anti depression, anti epilepsy, anti dementia and other aspects The drug market in these areas occupies a large share in China, and the original research enterprises have begun to pay attention to the domestic market in this area The original research drug refers to the first drug on the market at home and abroad, which has carried out a complete clinical trial and has an authoritative position in terms of efficacy and safety In China, the original research drug is also defined as a reference preparation The State encourages the entry of the original research drug into the country, and analyzes from the aspect of priority evaluation, as follows: Note: Children's drug use is related to the dosage form, so the full name is listed, and other main active ingredients are listed From the above point of view, the original research drug mainly focuses on innovative drugs in the rapid evaluation The original research drug has carried out a complete clinical trial, and has a breakthrough effect in the efficacy Even if it has been listed abroad, the National Bureau will give priority to the evaluation according to innovative drugs, such as oxitinib, which was listed in the United States in 2015 and belongs to the third generation EGFR target drug, in August 2016 Apply for clinical application in February 2017, approve import, and give great support to the review speed.