Article 159th "administrative licensing law" provisions of article sixty-ninth of the situation, the State Food and drug administrationaccording to the request of the interested party or according to its functions, can revoke the drug approval documents.
160th the provisions of drug supervision and administration department and its staff in violation of this law, any of the following circumstances, correction by its superior administrative organ or the supervisory organ shall order; if the circumstances are serious, the persons directly in charge and other directly responsible personnel shall be given administrative sanctions:
(a) shall not accept the case in accordance with statutory requirements of the application for registration of the drugs;
(two) not in accepting public signs shall be publicized according tomaterial;
(three) in the acceptance, review, approval process, not to the applicants, interested persons to perform its statutory duty of disclosure;
(four) the applicant to submit the declaration materials are incomplete or inconsistent with the statutory form, not a inform the applicant must all make up the contents of the;
(five) fails to explain not accepting or not to approve the application for drug registration;
(six) a hearing shall be held without hearing according to law.
161st if a pharmaceutical supervisory and administrativedepartments and their staff in drug registration process to ask for or accept the property of others or seek other benefits, which constitutes a crime, shall be investigated for criminal responsibility according to law; if no crime is constituted, administrative sanctions shall be imposed according to law.
162nd if a pharmaceutical supervisory and administrative department in drug registration in any of the following circumstances in the process of correction, by its superior administrative organ or the supervisory organ shall order, the persons directly in charge and the other persons directly responsible shall be given administrative punishment; constitute a crime, shall be investigated for criminal responsibility according to law:
(a) to approve the registration decision or made beyond the statutory functions and powers granted registration decision does not meet the statutory conditions for the;
(two) make a decision or not registered within the statutory time limit to grant registration decision application which meets the statutory conditions;
(three) in violation of the provisions of the provisions of article ninth did not fulfill the obligation of confidentiality.
Article 163rd drug inspection office for drug approval requiredinspection work, issued a false inspection report, shall be punished in accordance with the "Drug Administration Law" article eighty-seventh.
Article 164th the drug supervision and Administration Department of unauthorized charges or fees is not in accordance with thestatutory items and standards, by its superior administrative organ or the supervisory organ shall order it to return the illegal charges; the leading persons directly in charge and other directlyresponsible personnel shall be given administrative punishments.
Article 165th in the drug registration in accordance with the provisions of the implementation of "no pharmaceutical non clinical research quality management standards" or "drug clinical trial quality management standards", shall be punished in accordance with the "Drug Administration Law" article seventy-ninth.
166th the applicant declared in the clinical trials, submitted false drug registration information and samples, the pharmaceutical supervisory and administrative departments shall not accept or clinical trial of the drug is not approved the declaration, a warning shall be given to the applicant, the applicant does not accept thedrug clinical trial application within 1 years; have been approved for clinical trials, revoke the approval approval of the drug in clinical trials, and impose a fine of 10000 yuan and 30000 yuan,the applicant of the drug clinical trial application will not be accepted within 3 years.
The drug supervision and Administration Department of the applicant to submit false information and sample builds bad behavior records, and shall publish.
Article 167th apply for drug production or import, the applicant to submit false drug registration information and samples, the State Food and drug administration shall refuse to accept or not to approve the application, give a warning to the applicant, the application will not be accepted within 1 years; have beenapproved for production or import, revoke the pharmaceutical approval certificates, the application may not be by 5 years, be subjected to a penalty of between 10000 yuan and 30000 yuan.
Article 168th in accordance with the provisions of the provisions of article twenty-seventh, the need for drug test, the applicantrefused, the State Food and Drug Administration for it shall be given a warning and shall be ordered to make corrections, the applicant refuses to correct, not to approve the application.
Article 169th under any of the following circumstances, by the State Food and Drug Administration cancelled drug approval number, and publish:
(a) under valid approval documents, the applicant proposedcancellation of drug approval number;
(two) in accordance with the provisions of article 126th shall not be re registered;
(three) "drug production license" or shall be revoked according to law;
(four) in accordance with the "Drug Administration Law" forty-second and "drug management law implementation rules" in article forty-first, the serious adverse reaction, or other factors h, armful to human health and drug, revoke the approvaldocuments;
(five) to cancel the administrative penalty decision, the drug approval certifications according to law;
(six) the other shall be revoked according to law or to withdraw thedrug approval documents.