Proprietary Chinese medicine batch enlargement need to be filed

Need to record. According to the "Drug Production Quality Management Standard Certification Management Measures" (State Food and Drug Administration An [2011] No. 365), Article 8, drug manufacturers to alter, expand the workshop or production line, should be in accordance with this method to re-file the application for drug GMP certification. Proprietary Chinese medicines are a kind of traditional medicines in China, which are widely used in Chinese medicine clinical treatment, with the advantages of low side effects and mild efficacy.