關(guān)于化學(xué)藥品注冊分類及申報資料要求部分問題答疑

1、關(guān)于化學(xué)藥品注冊分類及申報資料要求部分問題答疑questions are asked about the classification of chemical drugs and the requirements of the declarationforeign listed, domestic uniisted pharmaceutical, change its dosage form, increase the indication of the disease to press a few new drug to declare?answer: according to the ch

2、emical medicine register classification 3 to declare, after approval, follow the supplement application to increase the indicationswill the needle, needle and still drip form convert to the new drug, or will it be submitted for approval? do you need clinical research? do you want a new drug certific

3、ate?answer: the variety of unlisted sale is applied to new drug according to the new drug, the certificate of new drug is issued after approva1. there are already existing national standards for drug application in accordance with existing national standards, and no new drug certificates are issued

4、after approva1. transformation between water booster injection and static drops of dosage form of application, if the way and method for drug and dose, and generally do not need to conduct clinical studies, but the applicant must be a pharmaceutical production enterprise have the corresponding produ

5、ction conditionsif the normal film is changed to a s1ow release, the release age nt, if the qua ntity of the drug is con sta nt, can it be used as an animal pharmacological agent, only for clinical druggeneration?a: in "method" in item 4 in attachment 2) filings and instructions specified

6、in article 20, quick release, slow release and controlled release preparations shall at the same time provide compared with common preparation of single or multiple dosing animals pharmacokinetic research materials therefore, the kinetics of animal drugs cannot be avoidedhas the animal tissue extrac

7、t, which has not been approved for clinical study, be returned to the requirements of biological products?answer: no need to return. the pharmaceuticals that are applied for shall be subject to the approval of the requirements of annex ii of the measures if the application is made of biological prod

8、ucts, we shall undertake the examination and approval according to the requirements of annex iii of the measuresare genetic engineering hormones and enzymes to be declared by biological products or by chemical medicine?a: genetic engineering hormones are regulated by biological products; the enzyme

9、preparation of a single component is governed by the chemical medicine, and the multi-component enzyme preparation is under the management of biological productsis the listed drug available at the same time to change the dosage form, the way of medicine, indications and so on? howdo you fill in the

10、new drug class?a: ok. drugs that have already been listed in china, change the dosage form and change the way to the drug, the form of which is not listed abroad, it is registered class 2: listed, category 3. additional indication is a supplementary application, only after the application has been a

11、pproved.7. the domestic foreign-funded enterprises may buy foreign parent company has approved but not yet registered in our aerosol spray apparatus and powder in the domestic assembly, declare new drugs? how do you declare the import of imported equipment and powder? is it a production or import? i

12、s there a production period after approval?answer: the spray appliance is managed by medical device, according to the requirement of our bureau to be prepared for medical device pharmaceutical powder is a pharmaceutical, according to "method" register classification 3 declareif the applica

13、tion is submitted to the department of medicine registration of our bureau, the pharmaceutical registration department will transfer the information about medical devices to the medical equipment department; you may apply to the medical device department of our bureau, and the medical equipment depa

14、rtment will transfer the relevant information to the pharmaceutical registry.after approval, the registration shall be re-registered according to the relevant requirementsimport a certain kind of preparation, but do not import raw material medicine, domestic apply for this variety of raw material me

15、dicine and preparation how to apply?answer: raw material medicine according to register classification 3, preparation presses register to classify 6 applicationthe test room of the drug safety test has no glp certificate, the on-site evaluation is qualified, and the test data is approved?answer: the

16、 recognition.is the requirement for the application of the trial standard of drugs to be the same as that of the original "new drug examination and approval management measures" and "new biological products examination and approval managementc measures ?a. not exactly. "the way&q

17、uot;,the trial standard transfer shall be handled according to the supplementary application, and the requirements for the declaration shall be carried out in accordance with the relevant provisions of annex 4.the new drug is approved, the import drug is registered and the chinese version of the for

18、eign language is fully translated or abstract?a: the whole translation.is there no public publication, and is there a legal source of foreign information as a declaration?answer: yes, but must comply with the requirements of article 14 and article 21 of the measurescan the drugs and the drugs that h

19、ave been passed in the trial period of the trial period have been approved for extension?a: the standard transfer should be applied at the prescribed time limit the drugs that have been passed by the original trial standard shall be carried out in accordance with the relevant provisions of the docum

20、ents of the state pharmaceutical surveillanee (2002) 437can the combination of the compound be allowed to contain unapproved drugs?a: no.is there a probation period for imported medicines?a: the standards for imported drugs are standard for registration, and there is usually no trial periodis the mo

21、nomer compound extracted by the plant?a: it is feasible to comply with the requirements of chemical drugs.do both the material and the preparation have to be inspected and sampled at the same time?a: yescan the applicant of a variety of products be imported from the same species during the surveilla

22、nce period of the new drug?answer: can not imitate this breedhow to declare the application for the approval of the original pharmaceutical or import registration certificate for the listed manufacturer?answer: this raw material drug has already been listed, according to "the drug registration

23、management method" annex 2 to register classification 6 declare, the approval is sent to the approval document number; unlisted, according to the measures for the administration of drug registration registration category 3 declaration in attachment 2, can undertake clinical research, does not r

24、equire the new drug certificate shall be issued upon approval and approval numberdoes the non-pharmaceutical manufacturer declare the raw material of the standard preparation of the national standard preparation, the pre-clinical and clinical data on the preparation of the preparation? do you need t

25、o use the instruction manual?a: no preclinical and clinical studies of preparation are required no instructions are required for the raw material.can the raw material production plant be able to make the powder to be sold to the preparation factory to make the capsule preparation?a: no.do you write

26、all the ingredients in the prescription, or do you only write the main ones? do you need a source to prove it?a: all the registration will be listed and the source of the application will be attached. in the instruction manual, over-the-counter medications are all listed, and prescription drugs can

27、only be listed in the main ingredientshow to change the variety, content, and source of the ingredients?answer: according to supplementary application processinghow to declare the "sugar coat to "thin film garment"?answer: the enterprise that produces sugar and clothing piece applies

28、for production of film and clothing film, according to supplementary application declaration; enterprises that do not produce sugar sheets are applying for production of film and clothing, according to the national standard and drug declarationwill the validity of the provisional drugs be calculated

29、 according to the relevant formula? is the validity of the listed products valid according to the results of the sample stability test?answer: the accelerated stability test can be used as the basis of a tentative validity, but the validity of the listed drugs must be based on a pilot scale above pr

30、oduct data to determine the stability of the testcan the prescription be modified after the clinical study is approved? change the form? increased indications? change the unit of clinical research?a: clinical research after approval may be altered clinical research unit, and to the provincial drug a

31、dministration for the record, but can not modify prescription, changing the dosage form or add indicationshow do the number of control cases in the clinical study set? is there a control study for phase iii?answer: according to "method" article 27 the regulation executes30.can a drug be re

32、ported for multiple indications at the same time?a: ok.if the medicines for multiple indications are to be applied, such as the method of drug administration, can i be used in the phase i clinic? will the number of clinical cases of ii and iii be reduced? what are the specific rules?a: phase i clini

33、cal trial is to observe the human body the degree of tolerance for new drugs and pharmacokinetics, to provide evidence for dosage regimen, does not involve the use of indications, so there is no common problems the phase ii and iii phase need to be conducted in accordance with different indications,

34、 and the requirements for clinical research are in accordanee with the provisions of the fifth article in annex ii of the measuresis there a uniform requirement for the basic content of the clinical researcher，s manual?a: according to the relevant provisions of the gcpdoes the study of human bioavai

35、lability also requireinformed consent" and the review by the ethics committee"?a: the human bioequivalenee study belongs to the category of clinical research, must be carried out according to the requirements of gcp and therefore human bioavailability studies also need to beinformed consen

36、t", "ethics committee approval documents review etcthe quality standard is the same, the declaration of the production process differs from the clinical drug production process, whether need to declare the change of the production process separately?a: changes in the production process mus

37、t be reported and submitted to the relevant pharmaceutical materials, and clinical studies should be carried out if necessary.36 listed samples (including declaration production samples) before packaging self-control, listed product packaging in accordance with the state drug administration bureau t

38、o the provisions of the no 23 printing, whether it is feasible?a: ok. but the clinical research uses the packaging, labelling and the instructions of the drug to comply with the relevant regulations.is the change in the dosage and dosage of the listed drugs under revision?a: yes38. new businesses, n

39、ew shop in front of the gmp certification, continuous production of 3 products in this workshop, according to the production obtained drug approval number, can the 3 batches of product sale? (the workshop will receive gmp certification as scheduled)a: no, only with the pharmaceutical production lice

40、nse and the drug production quality management standard certification of workshop production, by the state drug administration to determine the drug inspection offices of qualified after an approval number and achieve, to apply for new drug samples of three batch production, can be in the market at

41、the period of validity of the drug.can the gmp certification workshop for chemicals (or chinese medicines) be used for the production of traditional chinese medicine (or chemicals) in the same dosage form?answer: general is ok, but special breed is not ok, be like penic訂lin class etcdoes the researc

42、h unit declare the new drug independently? otherwise there is no transfer of new drug technology after obtaining the "new drug certificate"?a: yes, but only after the approval is given to the new drug certificate and no approval document for the drugis the import registered drug that belon

43、gs to the rapid examination and approval to accelerate the examination and approval?a: ok.should the approved drugs be accelerated?a: applicants need to item 3 in the drug registration application form shall be indicated in the ''additional application matters" and put forward the appli

44、cation, the provincial drug administration should apply for whether can meet the requirements of rapid examination review and put forward opinions, state drug administration at the time of acceptance, determine whether to conduct rapid exam in ation and approval of the new drug applicationswill the

45、approval of drugs be accelerated?a: no, rapid approval is accelerated from time to time, and the requirement for filing is not reducedwhy don，t you give the first registration of imported drugs in china? is it against the principle of national treatment?answer: the monitoring period is for domestic

46、pharmaceutical production enterprise production production approval of new drugs for the first time and set up a monitoring system for the technical, the purpose is according to the requirements of maintaining public health and safety and quality control of drug monitoring. "the first listed im

47、port drug in china" was actually listed abroad,so there is no longer a monitoring periodafter the approval of the new drug approved by the new drug, the monitoring period of the new drug will be completed at the same timea: at the same timewill the import registered drugs which have been accepted before the monitoring period of the new drug be received, and will the domestic drug continue to be approved after the monitoring period? is