Information that should be submitted with the application for drug registration of radiopharmaceutical drugs are as specified in Appendices 10 and 11.The application should comply with the Guidelines on Clinical Trials of Radiopharmaceutical Drugs and the Guidelines on the Assessment of Radiopharmaceutical Drugs as announced by the central health competent authority.Regulations for new drugs stipulated in this Chapter are also applicable to radiopharmaceutical drugs with new dosage forms and new doses.Appendix 10：Documents Required for the Application for Drug Review and Registration of Radiopharmaceutical Drugs.pdfAppendix 11：Technical Documents Required for the Application for Drug Review and Registration of New Drugs, New Dosage Forms and New Dose of Radiopharmaceutical Drugs.pdf