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Recently, CDE issued a "notice on public consultation on the Technical Guidelines for Clinical Trials of Chemical Lycouted New Drugs (Draft for Comments)", giving guidance on how to conduct clinical trials of improved new drugs (i.e., Class 2 new drugs).
, at the same time, the author found that in recent years, China's two types of improved new drug registration declaration overall increasing trend, and many domestic 1 new drug varieties in the market, most of the two-class direction of improved development, improved new drugs are gradually becoming a scientific compliance with the development of the registration declaration of a new battlefield.
"every holiday to stay homework", almost become NMPA and CDE daily work arrangements, drug practitioners are also used to the day before the holiday afternoon and evening, browse the official website issued the job title;
on the 24th of this month, CDE official website issued a public consultation on the "Chemical-improved new drug clinical trial technical guidelines (draft for comments)" notice, how to carry out the clinical work of improved new drugs (i.e., class 2 new drugs) to give guidance.
this guiding principle (draft for comments), is led by a clinical department of chemical drugs, started in April 2020, in May 2020 to form a first draft, after the internal discussion of the drug review center, the technical committee review, after soliciting the views of some applicants, the formation of a draft for comments.
Figure 1.1: CDE issued relevant guidelines 1.2017 - So far the domestic improved new drug declaration statistics Since the drug registration classification reform, domestic enterprises for the registration of 2 types of modified new drugs, the number of registration sourcing, the number of increasing trend, perhaps this is one of the reasons why CDE issued the guiding principles (opinion draft) to regulate the development of improved new drugs.
through drug data query, in 2017 CDE to undertake a total of 46 new drug acceptance numbers, 2018 for 50, 2019 for 88;
Figure 2.1: 2017-present and domestic improved new drug declaration statistics 2.2020 first half of 2020 2 modified new drugs introduction 2020 (statistical date end of 2020627), the number of domestic 2 types of modified new drug registration acceptance number is 60, detailed varieties and enterprises see table 3.1.
domestic improved new drugs, in general 2.2 and 2.4 categories for domestic registration and declaration hot spots, that is, new dosage forms and new indications mainly.
Table 3.1: 2020 first half of the domestic 2 drug registration declaration statistics (data derived from drug intelligence data) 3. First half of 2 types of improved new drugs partial varieties introduced chemical drugs 2.1 class 2020 first half, with chemical drugs 2.1 class registered declaration of only 2 varieties, respectively, Hefei HYR-PB21 (to-dosicindication: postoperative single-dose local immersion anesthesia or peripheral nerve block anesthesia) and Jiangsu Hengrui developed the injection hr18034;
class 2.2 preliminary statistics, in the first half of 2020 the domestic registration of 2.2 chemical drugs registered a total of 28, involving 20 active ingredients.
, the domestic class 1 new drug butylbenzene, by Nanjing Yuke Pharmaceutical Co., Ltd. and Nanjing Libovi Pharmaceutical Co., Ltd. jointly registered the declaration of butyl benzene injection; The hydrochloric acid iliticoside lipid injection developed by Nanjing Green Leaf was registered with the chemical drug 2.2/2.3, and the injection of Grebenia developed by Jiangsu Osaikang Pharmaceuticals was registered with 2.2/2.4.
chemical drugs 2.3 class to chemical drugs 2.3 class registered declared only 3 varieties, in addition to the above-mentioned hydrochloric acid Iliticonfluene lipid injection, there is also Nanjing Yuke Pharmaceutical's compound Idalafon injection, Jiangsu Hengrui's HR18042 tablets.
2.4 class in the first half of 2020 in China with 2.4 chemical drugs classification registration of the acceptance number of a total of 29, involving 11 active ingredients.
, the domestic class 1 new drug methyl sulfonate apatinib, hydrochloric acid anrotini, toluene sulfonate rzeazole, toluene sulfonate nirapali, zebuttini, methyl sulfonate ametinib, are registered to declare, the process and results are worth looking forward to.
4. Summary In recent years, the author will summarize the domestic new drug registration declaration, 1 class of new drugs, especially in the inD aspects of the varieties, registration declaration is very hot! In contrast, class 2 improved new drugs are relatively tepid... And the publication of the guiding principles (draft for comments), so that the author once again pay attention to the registration of class 2 new drugs, found that the number of their declaration is steadily increasing, perhaps this is one of the reasons, so that CDE feel the need to give some guidance on the development of class 2 new drugs at this time.
the release of guiding principles, clear what to do and what not to do, will certainly make enterprises in the process of 2 new drugs to save a lot of costs, and at the same time, will also make the development of 2 types of new drugs more scientific, compliant, orderly!