The first section of the drug registration standards
Article 136th the national drug standards, refers to the State Food and Drug Administration promulgated the "Pharmacopoeia of people's Republic of China", the drug registration standards and other drug standard, its content includes the quality standard,inspection method and production technology.
Drug registration standards, refers to the State Food and Drug Administration approved applicants specific drug standards forpharmaceutical production enterprise, production of the drug mustperform the registration standard.
The provisions for drug registration may not be lower than the standard of Chinese pharmacopoeia.
Article 137th drug registration standards project and test set,should comply with the basic requirements of Pharmacopoeia of the people's Republic of China, the State Food and DrugAdministration issued the technical guiding principles and the national drug standard compilation principle.
138th the applicant shall select the representative research workof standard sample.
The second section pharmaceutical standard material
Article 139th pharmaceutical standard material, is testing for drug standard of physical and chemical testing and biological methods,with certain quantity, used for equipment calibration, evaluation of measuring methods or to test drug assignment substances,including standard, standard, in medicine, reference.
The 140th China drugs and biological products inspection is responsible for standardizing the national drug standardsubstance.
Chinese drug and biological products assay may organize therelevant province, autonomous region, municipality directly under the central government, drug control, drug research institutions ordrug production enterprise collaboration standardizing the national drug standard substance.
The 141st China drugs and Biological Products Inspection Institute of standard calibration from raw material selection,preparation method, calibration method, the calibration results,the accuracy of fixed values, traceability, stability and packagingtechnology and packaging conditions comprehensive audit data,and can be used as the national drug standards materialconclusion.
The third section drug name, description and Tags
Standard name, 142nd applications for registration of drugsmanual and labels shall conform to the State Food and drug administration.
The 143rd drugs manual and labels by the applicant, the StateFood and drug administration center according to declare the data to examine the inter enterprise information content inpharmaceutical production, approved by the State Food and Drug Administration approved.
The applicant shall be responsible for the pharmaceutical directions and labels of the scientific, normative and accuracy.
144th the applicant shall follow the post marketing drug safety andeffectiveness of the proposed amendment, supplement of drug instructions timely application.
145th the applicant shall, in accordance with the provisions of the State Food and Drug Administration format and requirements,according to the approved content printed instructions and labels.