July 21，CDE has published three consecutive announcements: First, the opinions of "The Basic Principles of the first imitation & rdquo; the basic principles of the first imitation & rdquo; varieties" and the publicity of the publicity of the first imitation & rdquo;，Second, it is intended to be included in the public announcement of the registration application for priority review procedures; the third is to include the publicity of priority review procedures for drug registration。

 

  This article focuses on the analysis of & ldquo; first imitation & rdquo; priority review approval system，Analysis of the Drug Catalog of Related Priority Review of CDE。

 

  A、& ldquo; The first imitation & rdquo;

 

   & ldquo; The first imitation & rdquo; varieties are included in three conditions for priority review

 

  To strengthen drug registration management，Speed ​​up new drugs with clinical value and research and development of new drugs and clinical urgent need for generic drugs，Conflict on the backlog of drug registration applications，CFDA's priority review and approval system was determined in February 2016。Pharmaceuticals with obvious clinical value and registration applications that belong to the type of disease that are targeted and have obvious clinical advantages are the scope of priority review and approval，But & ldquo; First imitation & rdquo; There is no incentive for priority review and approval。

 

  July 21, 2016，CDE also incorporates & ldquo; first imitation & rdquo; varieties also incorporate the scope of priority review and evaluation。

 

  So，What medicines can be included in the first imitation & rdquo; There are three conditions:

 

  First, there is only one import of the same variety.

 

  Where，The same variety refers to the same active ingredients、Products of the same way of administration，and distinguish the special preparation from ordinary preparations，If the micro -ball injection and ordinary injection are regarded as two different varieties。This means that the domestic & ldquo; the first imitation & rdquo; no need to mind whether the import manufacturer that has been listed is currently listed，& ldquo; First imitation & rdquo; medicine is just for domestic production manufacturers。

 

  The second is to review the same variety，The sequence of the host date of the drug review center belongs to the first one，If & ldquo; First imitation & rdquo; Register application review and not approve，The date of the hosting of the drug review center will be added in order stake betting appstake online sports bettingto add a registration application for the post.。

 

  CDE issued in March on the notice of the "Principles of How to Depete the Applicant's Principles" issued in March.，Apply for many applicants of the same variety，CDE determines the applicant，The first application for the first application is given priority review; the same day is determined to be the first，At the same time, give priority review。CDE receiving review task time determination，Paper declaration materials required to register the product, the completed payment and the electronic application form have been transferred to CDE，and develop site inspection report、Production site inspection report、The sample inspection report has been submitted。

 

  Third, it has exceeded the period of legal review.

 

  According to the management measures of drug registration，The so -called & ldquo; Drug registration time limit & rdquo;，Is the acceptance of the registered drug、review、The longest time for approval，The time used in accordance with the provisions of laws and regulations or the time used by the applicant's supplementary information is not calculated。

 

  Provincial、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall complete the verification of the research and development and original materials within 30 days after the application application、Test the application information、Sample、Notification of the Drug Inspection Institute for a registered inspection。Pharmaceutical registration test 30 days，Sample inspection and standard review at the same time。Technical review working hours，Application for the dosage form and generic drugs that have been listed on the market for 160 days。CFDA shall make an approval decision within 20 days; the decision cannot be made within 20 days，Approved by the leaders of the competent Bureau，Can be extended for 10 days，and the reason to inform the applicant of the reasons for extending time limit。CFDA shall be issued within 10 days from the date of the decision to make a drug registration approval decision、Deliven the relevant administrative license documents。

 

  To sum up，The review and approval of the review and approval of the generic drug is about 250 days，Now & ldquo; It has exceeded the legal review period & rdquo;，This is more like a policy compensation mechanism。

 

  Old registered classification 6 categories 6 medicines are also considered first imitation

 

  July 21，The first batch of & ldquo; the first imitation & rdquo; the list of varieties for the first batch of the currently to be reviewed.，Among the earliest dates of the hosting until June 2011，Report from the latest until the end of October 2015 (that is, 9 months ago)。

 

  Old Registered Classification Class 2 3.1 new drugs，1 5 new medicine，19 6 types of 6 generic drugs。In previous tender，The first imitation medicine has a single -column preferential treatment in individual provinces or the additional score incentive of technical scores in dual envelope。However, the definition of the first imitation & rdquo;，Individual bidding office stipulates that only the old registered classification of 3.1 drugs can be considered the first imitation，6 category is not counted。From this list,，6 Category My stake betting appMy stake betting appof generic drugs and only one imported medicine at the same time can also be counted as the first imitations。

 

  Company aspect，Hubei Yuanda Tiantianming Pharmaceutical Co., Ltd.、Jiangsu Hengrui Pharmaceutical Co., Ltd.、Qilu Pharmaceutical Co., Ltd. and Zhengda Tianqing Pharmaceutical Group Co., Ltd. each have 3 acceptance number shortlisted lists。

 

  Dosage form，& ldquo; First imitation & rdquo; List encourages more non -oral medicine: the most accepted number of injections，7; followed by eye drops，There are 6 in total; cream、An ointment and gel ointment also has 4。

 

  B. An Announcement List of Priority Review Approval Announcement

 

  A total of 19 acceptance numbers to enjoy the priority review

 

  In addition to the first imitation & rdquo; registration application list，As of July 21, 2016，CDE announced the relevant priority review of the drug directory，A target that belongs to the target with obvious clinical advantages to overcome the type of disease.、Rare disease、Viral hepatitis and malignant tumors, etc.;，Drug application applications that are 3 years before the patent expires and 1 year before the patent expires have also been publicized。At present, a total of 80 acceptance numbers have been included in the public list，A total of 19 acceptance numbers for priority review and approval were determined。

 

  In addition，The National Health and Family Planning Commission is also targeted at children's clinical need、Drugs in market shortages have produced a list of drug catalogs that encourage registration，Involved 32 products。This list is more inclined to encourage the use of medication and cardiovascular system for the nervous system，Especially anti -anxiety and antiepileptic drugs，Such as benzene cable、Benzya sodium、Di Xixi、Fluoriopidol、Lauraci、Chleosizi、Midazazolehon、Hydrochloride and Zuo Yiraistein，and the high blood pressure for the treatment of hypertension、呋 Semi、Katopoli、Nimo Ping、adrenaline、Huafarin and two nitrogenzide。

 

  The list of preferred review announcements is there self -inspection and verification varieties?

 

  In addition，Announcement on the "Announcement on the Checking of the Pharmaceutical Clinical Test Data Research" (Self -Checkout Project No. 117, 2015)，The applicant takes the initiative to withdraw and change to the standard of reciprocating drug registration that is re -declared in accordance with the standards of the original drug quality and efficacy.。

 

  Xianda Data V3.2 Discovery，Children's medication application catalog (first batch) of children with priority review and approval (first batch) chlorfalrabin injection (accepting number CXHS1200249)、Priority review procedure Laibamide capsule (accept number CXHS1400266 for anti -tumor drug registration application、CXHS1400267 and CXHS1400268)、April 28th priority review procedure registration application application application application application application application application application application application application application application drug registration application application application drug registration application application application application application drug (accept number Cyhs1490010)、McGee Capsule (Acceptance Number JXHS1500026)、July 21st Azatidin (JXHS1400125)，and the & ldquo; the first imitation & rdquo; the rich pomocarin norofovir (CXHS1400157) and the alcoholic alcoholic acid (CXHS1200320)，All belong to the 1,622 self -check checklist released on July 22, 2015。

 

  In addition，July 21st stake sports betting appStake Sports BettingReview Procedure and Drug Registration Application for Ruigo Feitini (Acceptance Number JXHS1500103)、Renicinibicinib tablets (acceptable number JXHS1500114) and citrus citrus pipyette (accepting number JXHS1500126)，and & ldquo; the first imitation & rdquo; the list of varieties list (CXHS1500143)，In the second batch of self -check checklists。

 

  For the drugs (especially oral solid preparations) are included in the above -mentioned priority review and approval,，Identity is a bit embarrassing。Because in accordance with the latest registered regulations，This kind of medicine must be consistent evaluation to be approved，The above products may not be studied in accordance with the existing regulatory processes，For example, there is no original research sample filing in one -time research，So even accelerate，Can it pass a question。

 

  In view of this，Preferred review approval drug catalog，Products that belong to domestic manufacturers and are oral solid preparations，It is very difficult to obtain the first imitation of the first imitation in accordance with the current registered regulations。For Villaryville Capsules、Fogaic acid for Norofovir two pyrarodidone capsules、Jifei Nini Film、The products of Casunine Hydrochloride Tablets and Stubbarbara Tablets，Domestic enterprises need to evaluate their market scale、Competitive trend (whether there are similar varieties in the application manufacturers at the same time in Europe and the United States) and the difficulty of passing consistency imitation，Fang to consider the formulation of the project。

 

  Is some varieties be preferentially examined

 

  After careful reading and reviewing the assessment principles and screening varieties of the review center，As industry insiders，Summary summary as follows:

 

  1. First imitation variety preferred review，First of all, you should pay attention to clinical necessity，Followed by the availability of medication，registered back pressure again。

 

  2. Among the 22 varieties listed in the file of the file，There are 4 varieties used to treat open glaucoma，is the front column vegetarian、Belimi Pre -column、Billinamine and Qu Fu 噻。Where，The primary primary and Belimin are prostaglandin derivatives，Bollingamamine is a carbonate enzyme inhibitor，Quovan? It is the compound preparation of the prostrate and 噻 (adrenaline & beta;-receptor block)，So，One possibly primary primary vegetarian and Belomi primary vegetarian may be more appropriate，Due to the leading date of the collaterals in front of Qu Fu，Suggestion Preferred。

 

  3. Siterk and Gunarik are structural analogs，All are promoting gonadotropin to release hormone inhibitors，May wish to take one in one。Because the undertaking date of Xitarik is the top，Suggestion Preferred。

 

  4. Compound fluoroneon and butyl chloropatate is cortical steroid drugs，More clinical replacement varieties，List as a priority review variety or need to be considered again。Similarly，Whether Losoropen as a non -sterite anti -inflammatory analgesic drug is included in the priority review channel，You should also consider more。

 

  (Dr. Chen Shun, Hua Likang, Shenzhen)

 

  Speed ​​up for review and approval, method innovation is also very hard

 

  Facing the problem of the backlog of drug registration applications，The relevant Stake Sports Bettingstake online sports bettingpolicies of the competent department are also very hard in method innovation。

 

   & ldquo; First imitation & rdquo; The variety shall belong to the "Opinions on Solving the Capital Evaluation Approval of Pharmaceutical Registration Application" (Food and Drug Supervision [2016] No. 19) referred to: & ldquo; Clinical trial application and patent application and patent application and patent expiration 1 year before the patent expiration of patents & rdquo; one category。Publicly publicize the selected varieties，It is a further refinement and clarity in operation。But on the other hand，According to the requirements of Code 19，Pharmaceutical registration implementation approval should be approved by the registered applicant first，Now the logic of & ldquo; first imitation & rdquo; to select specific varieties to solicit opinions，Where there is any discussion。After all, the basis for the listing of drugs should be its clinical value，or is it urgently needed for clinical practice。This publicity time is urgent，No system in the registered applicant、Comprehensive application for the reasons for the review and approval of the comprehensive application for review and approval，It is estimated that there is a certain difficulty for raising the reason for sufficient reasons。Of course，To improve the efficiency of review and approval，For such a clear measures，I believe the industry still supports and welcome。

 

  (Chen Zhouquan, a doctoral research and development doctor of a large pharmaceutical company)