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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Lixue Zhang

College of Professional Studies, 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

    Abstract HTML PDF

Google Scholar citation report
Citations: 533

Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report

Pharmaceutical Regulatory Affairs: Open Access peer review process verified at publons

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