Regulations for Registration of Medicinal Products Article 24

Except as otherwise regulated, all applications covered in this Chapter are subject to a parallel assessment of dossier review and drug testing. If the submitted dossiers pass the assessment, then the applicant should follow the notice issued by the central health competent authority to collect the license. Once the test specifications are approved, the applicant should follow the notice issued by the central health competent authority to proceed with drug testing.The following applications only require dossier review, while drug testing can be exempt except for those cases deemed by the central health competent authority as drug testing being necessary.1.Drug registration:(1)Pharmaceutical preparations classified as OTC drugs (including Class B OTC drugs);(2)Vitamins meeting the criteria for products containing vitamin substances;(3)Generics;(4)Pharmaceutical preparations meeting the criteria set out by the Guidelines on the Review of Over-the-counter Drugs;(5)General active pharmaceutical ingredients; and(6)Pharmaceutical preparations and active pharmaceutical ingredients for exportation only.2.Post-approval changesAs mentioned in the preceding paragraph, for those drugs that only abide by dossier review, the applicant should submit color photos or scanned images of a sample product for assessment. If necessary, a reference standard should be provided for comparison.