146th if a pharmaceutical supervisory and administrative department shall abide by the "Drug Administration Law","administrative licensing law" and the "Drug Administration Law Implementing Regulations" provisions for drug registrationdeadline requirements. Said the drug registration time, the long time of drug registration acceptance, examination, approval and other work, the use of less calculation, according to the provisions of laws and regulations to suspend approval or the applicant to provide supplementary materials.
The drug registration inspection, review time shall be implemented in accordance with the provisions of the present measures. There is a special reason need to extend the time, it shall explain the reasons, report to the State Food and Drug Administration for approval and notify the applicant.
147th if a pharmaceutical supervisory and administrative department for examination after receiving the application form,and dealt with separately according to the following circumstances:
(a) applications in accordance with the law are not subject to administrative license, it shall immediately inform the applicantdoes not accept the;
(two) applications in accordance with the law does not belong to the scope of the functions of the Department, it shall immediatelymake a decision of rejection, and inform the applicant to apply tothe relevant administrative organ;
(three) the declaration materials can be corrected on the spot arewrong, the applicant shall be permitted to correct them on the spot;
(four) application materials are incomplete or inconsistent with the statutory form, it should be on the spot or in all of the first 5 days to inform the applicant should be supplemented, if it fails to do so,since the receipt of the declaration data date is accepted;
(five) apply items fall within the scope of its functions, application materials are complete and in statutory form, or the applicant hassubmitted all the information in accordance with the requirements of rectification, it shall accept the application for drug registration.
The pharmaceutical supervisory and administrative departments to accept or not to accept the application for drug registration, it shall issue a written document affixed with the special seal anddrug registration date.
Article 148th provinces, autonomous regions, municipalities directly under the central government, the pharmaceutical supervisory and administrative department shall accept the application within 30 days after the completion of the development and the original data verification, the application materials review,sampling, notify the drug inspection office registrationexamination, the examination opinions and verification reporttogether with the applicant's application materials submitted to theState Food and drug administration work, and notify the applicant of the examination opinions.
Article 149th drug registration inspection time in accordance with the following provisions:
(a) sample inspection: 30 days; at the same time sample inspection and review the standard: 60;
(two) the sample inspection of special drug and vaccine products:60 days; at the same time sample inspection and review the standard: 90.
In accordance with the provisions of article thirty-sixth by testing the drug clinical trials with sample test, should be completed in accordance with the preceding sample inspection time.
150th the technical evaluation work in accordance with the following provisions:
(a) new drug clinical trial: 90; admitted to the special approval procedures: 80 varieties;
(two) new drug production: 150; admitted to the special approval procedures: 120 varieties;
(three) to change the dosage form of drugs already on the marketand the generic application: 160;
(four) added the need for technical review application: 40.
Technical review time to apply for the registration of imported drugs according to the provisions of the preceding paragraph shall be.
Article 151st a need for additional information of the applicant in the technical review process, it should be a one-time issued a supplementary information notification, the applicant raises objection to the contents of the notice of the supplementary information, to listen to the applicant's statement. The applicant shall, within 4 months in accordance with the notice requirementsto complete the supplementary information, special approval to enter the program, shall be handled in accordance with therequirements of special approval procedures.
Receive additional information, technical review time shall not exceed the original provisions time 1/3; special approval to enter the program, shall not exceed the original provisions time 1/4.
Process of drug registration applicant to withdraw its application,the examination and approval procedures terminate automatically.
Article 152nd the State Food and drug administration shall make decisions on examination and approval within 20 days; can notmake a decision within 20 days, subject to approval of the competent authorities, may be extended by 10 days, and shallinform the applicant of the reason for extension of time limit.
Article 153rd the State Food and drug administration shall, within 10 days, the relevant administrative license issued by the registration and approval of drugs from the date of the decision is made.