Abstract

The pharmaceutical landscape in China is undergoing a significant transformation, driven by a growing demand for high-quality medications amidst improving living standards and an aging population. This surge in demand has attracted global Active Pharmaceutical Ingredient (API) manufacturers to explore opportunities within the China market. As China integrated into the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Chinese National Medical Products Administration (NMPA) implemented reforms to streamline pathways and enhance global collaboration.

To facilitate international API players in comprehending API regulations in China, this study delved into various regulations, announcements and guidance issued by the Chinese NMPA, combining insights gleaned from years of practical experience. This article presents a descriptive observational and review study on API regulations in China. It discusses the regulatory historical footprint of China Drug Master Files (China DMFs), the latest registration classification and quality considerations for APIs, focusing on starting materials, process validation, specifications and registration sample testing. Furthermore, it compares the registration classification to the US regulatory pathways. The study emphasizes the importance of regulatory compliance for international API manufacturers seeking to enter the Chinese market. Through this exploration, valuable insights are gained into the evolving regulatory landscape in China and its implications for international API manufacturers, aiding in their strategic decision-making processes and ensuring adherence to regulatory standards for successful market entry and product approval.