White Paper

6 Regulatory Changes Affecting Bioprocessing In China

Source: GE Healthcare Life Sciences

By Scott M. Wheelwright, Cofounder and Principal Consultant, Complya Asia

Recent reports about the Chinese pharmaceutical industry estimate its worth at $122.5 billion, making it the world’s second-largest national pharmaceutical market in 2017, with growth anticipated to reach up to $175 billion by 2022.1 Yet, challenges with regulatory policies in China that make entry difficult and costly are causing outside pharma companies to hesitate to expand their global footprint into the country, despite strong government support for innovation. Several scandals have also left a black eye on the country’s promising drug manufacturing industry.

There have been recent regulatory reforms to prevent future incidents as well as reduce regulatory burdens and minimize delays. Understanding what efforts are being made to facilitate market entry is critical for any company considering expansion into this challenging but flourishing area of the pharmaceutical industry.