Roadmap to Drug Approval Process in Chinese Market

 

Due to the increasing demand for high-quality healthcare, China has emerged as a major market for pharmaceutical products and is now one of the world’s leading manufacturers of pharmaceuticals. The market is ambitious and places emphasis on innovation and domestic research and development. By 2024, the Chinese pharmaceutical market exceeded USD 80 billion in revenue, making it the second largest in the world after the United States. The pharmaceutical manufacturing segment alone is projected to reach USD 183 billion by 2025. To get approval for any new medication to be launched into the Chinese market, one must understand the complexities of the drug approval process.

What Types of Drugs Are Approved in the Chinese Market?

  • Innovative Medications: Includes biopharmaceuticals, gene and cell therapies, as well as rare disease treatments. These treatments are created using the latest findings in immunology, genetics, and biotechnology.
  • Generic Drugs: Since there is a need for more affordable alternatives to branded drugs, generics play a dominant role in China’s market. Generics account for the majority of prescriptions, and China supplies about 40% of the world’s active pharmaceutical ingredients (APIs).
  • Chinese Holistic Health Products: Traditional Chinese Medicines (TCM) are valued at over USD 50 billion. They are deeply rooted in Chinese healthcare and include herbal, mineral, and animal-derived formulations that are gaining global recognition.

Which Regulatory Authorities Control the Chinese Pharma Market?

There are two main regulatory authorities that impact the Chinese pharmaceutical market:

Read more here: Roadmap to Drug Approval Process in China Market

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