China's legal framework for pharmaceutical products: challenges and opportunities for EU companies

Abstract

It is unanimously recognised in the literature that although the Chinese pharmaceutical market offers huge opportunities to European industry, it poses several challenges regarding compliance with the laws governing this sector. Because of the different legal traditions, a peculiar public health history and culture, and a different system of healthcare, EU companies have faced many barriers in accessing the Chinese pharmaceutical market over the years. In order to provide a better understanding of the China's regulatory landscape and its emerging trends, the article focuses on three critical legal topics, which are relevant for the business of EU pharmaceutical companies in the Chinese market: drug registration, drug distribution system, and IP rights protection.