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Regulatory Requirements for Registration of Pharmaceutical Product in China

China’s pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the world by the year 2050. However, entry to the market remains difficult for many international pharmaceutical manufacturers due to the country’s costly and complicated regulatory licensing requirements. In their paper, Saikiran Reddy D, Sirisha Kantheti, Srinivas Madhukar and T M Pramod Kumar of JSS University provide an overview of the regulatory licensing regime for pharmaceutical products in China, evaluating key features of the regulatory licensing regime through a law and economics approach.