Pharmaceutical Regulatory Affairs: Open Access

Department of Regulatory Affairs, Northeastern University, Boston, MA, USA

Publications

• Review   
  Regulatory Framework and Quality Considerations for Launching International Active Pharmaceutical Ingredients (APIs) into the China Market
  Author(s): Lixue Zhang*
  
  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 arti.. Read More»
  DOI: 10.37421/2167-7689.2024.13.409

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