Article 128th drug registration inspection, including inspection anddrug standard review.
Sample inspection, refers to the drug inspection according to the inspection applicants or approved by the State Food and Drug Administration drug standard of the sample.
Drug standard review, refers to an Institute for drug controlfeasibility, in the drug standard test method for scientific, set of projects and indexes can control the quality of drugs forlaboratory inspection and examination.
Article 129th drug registration inspection by the China drugs and biological products inspection institute or drug control of the province, autonomous region, municipality directly under the central government shall bear. Registration inspection of importeddrugs by the China drugs and biological products inspectionorganization and implementation.
Article 130th the following drug registration inspection by the control of pharmaceutical and biological products of China or thedrug inspection specified by the State Food and Drug Administration incurred:
(a) the provisions of article forty-fifth (a), (two) the provisions of drug;
(two) biological products, radioactive drugs;
(three) other drugs specified by the State Food and drug administration.
Article 131st allowed into the special procedures for examination and approval of drugs, drug inspection office shall give priority tothe sample inspection and drug standard review.
Article 132nd engaged in drug registration inspection institute for drug control, should be in accordance with the standards for quality control of pharmaceutical inspection laboratories and the national metrological certification requirements, personnel andequipment and drug registration inspection task to adapt, to meet the requirements of guarantee system and the technical quality ofdrug registration inspection.
133rd the applicant shall provide the drug registration inspectionneed relevant information, submit the samples or with the selectedsample for test, standard for inspection. Samples submitted orextraction for 3 times should be used in the inspection of biological products; registration inspection shall also provide the corresponding batch manufacturing test record.
134th Institute for drug control of drug standard review, in addition to the sample inspection, also should be based on the relevantresearch data, drugs of similar products at home and abroad and the state drug standards, puts forward review opinions on drugdrug standard, inspection items etc..
Article 135th requires the applicant to make drug standards, studythe applicant may not entrust some drug inspection opinions of review by the pharmaceutical standards; the drug inspection officeshall not accept the entrustment.