Article 1 [Legislative Purpose] The Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Regulations) is formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) and the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law).
Article 1 This appendix applies to the preparation of drugs for clinical trial (including investigational drugs and placebo). When using an approved drug as a comparator drug or investigational drug, this appendix also applies to its repackage and relabel.