Evolution of the registration regulations for proprietary Chinese medicines in China

In this review, we provide a comprehensive overview on the registration of proprietary Chinese medicines (PCMs) in China over the past century by examining published literature and historical data. We will examine this evolving administrative practice for PCMs registration in China, which is divided to the following five stages: (1) initial measures (1915-1948); (2) early development (1949-1965); (3) provincial approval and trial implementation of the “approval number” system (1966-1984); (4) legislation and cleanup (1985-1999); and (5) centralized national approval (2000 until now), offering a panoramic view on the characteristics of PCMs registration management in China.