Register to declare a new battlefield - class 2 new drug development.

Recently, Theof Pharmaceutical Sansic, 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 on improved new drugs (i.e., Class 2 new drugs)Well, in the study of guiding principles at the same time, the author found that in recent years, China's 2 types of improved new drug registration declaration overall increasing trend, and many domestic 1 new drug varieties in the market, most of the two types of improved development, improved new drugs are gradually becoming a urgent scientific compliance with the development of the registration declaration of the new battlefield"every holiday to stay homework", almost become NMPA and CDE's 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's official website issued a notice on public consultation on the Technical Guidelines for Clinical Trials of Chemical-Improved New Drugs (Draft for Comments) to guide the clinical work on how to carry out the clinical work of improved new drugs (i.e., Class 2 new drugs)this guiding principle (draft for comments), is led by a clinical department of chemical drugs, started in April 2020, formed a first draft in May 2020, after internal discussion by the Drug Review Center, the technical committee review, after soliciting the views of some applicants, the formation of a draft for commentsFigure 1.1: CDE issued relevant guidelines
Since the reform of drug registration classification, domestic enterprises for the registration of 2 types of modified new drugs, the number of increasing trend, perhaps this is one of the reasons why CDE issued this guiding principle (opinion draft) to regulate the development of improved new drugsthrough 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 - Domestic improved new drug declaration statisticsthe first half of 2020 (statistical date as 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 in the table belowDomestic 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 mainlytable 3.1 of the: First half of 2020 - domestic category 2 drug registration declaration statistics(Data derived from drug intelligence data)drug 2.1 classin the first half of 2020, with chemical drugs 2.1 class registered declared varieties only 2, respectively, Hefei Heyuan Pharmaceutical Seidogen sieinjection HYR-PB21 (proposed indications: postoperative single-dose local immersion anesthesia or peripheral nerve block anesthesia) and Jiangsu Hengrui developed injection HR18034;the preliminary statistics of theclass 2.2 of the chemical drug, the acceptance number of the domestic registration declaration with 2.2 chemical drug classification in the first half of 2020 was 28, involving 20 active ingredientsAmong them, the domestic class 1 new drug butylbenzene, by Nanjing Yuke Pharmaceutical Co., Ltdand Nanjing Libovi Pharmaceutical Co., Ltdjointly registered the declaration of butyl benzene injection; The hydrochloric acid developed by Nanjing Green Leaf Iliticonfluene lipid injection, to chemical 2.2/2.3 registration declaration;chemical drugs 2.3with chemical drugs 2.3 class registered declared varieties only 3, in addition to the above-mentioned hydrochloric acid Iliticonflueginoglicosine lipid injection, there is also Nanjing Yuke Pharmaceutical's compound Idalafon injection, Jiangsu Hengrui HR18042 tablets2.4in the first half of 2020 in China with 2.4 chemical drugs classified registration of the total number of 29, involving 11 active ingredientsAmong them, the domestic class 1 new drug methicillatin apatinib, hydrochloric acid anrotini, toluene sulfonate remamine, toluene sulfonate nirapali, zebuttini, methicatini, have registered declaration, the process and results are worth looking forward toin recent years, the author every quarter will summarize the domestic new drug registration declaration, 1 class of new drugs, especially in the inD aspectof 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 timeThe release of guiding principles, clear what to do and what not to do, will certainly make enterprises in the development of 2 types of new drugs in the process of saving a lot of costs, and at the same time, will also make the development of 2 types of new drugs more scientific, compliant, orderly!