China Regulatory and Legal Reforms: Gateway to Innovation and Global Integration

Sven Agten () and Ben Wu ()

A chapter in Biopharma in China, 2024, pp 21-39 from Springer

Abstract: Abstract Until a decade ago the Chinese pharma sector lagged behind internationally. Its products were of subpar quality, there was no standardization and innovation was non-existent. The ‘Healthy China 2030’ initiative however, changed all that. Over the last decade China has made significant strides in upgrading and updating all aspects of the healthcare system. A key pillar in these upgrades were the changes being made in its legal and regulatory framework for the pharmaceutical sector. This was needed in order to integrate with the global pharma market, to get better access to innovative medicines, and pave the way for the development of a real homegrown biopharma industry. The major reforms, initiated in 2015 have significantly improved all aspects of the biopharmaceutical sector. Major hurdles have been removed. By 2023 China had implemented the guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This is undoubtedly a milestone achievement, as it greatly improves market access for foreign companies, helps Chinese companies to venture outside China and improves patients’ access to innovative medicines. At the same the Chinese government has also introduced the Volume Based Procurement (VBP) policy, implemented the National Reimbursement Drug List (NRDL) and the process of price negotiations to get entry on the list. In this way the government wants to keep the price of medicines under control.

Keywords: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); Marketing Authorization Holder (MAH); National Healthcare Security Administration (NHSA); National Medical Products Administration (NMPA); National Reimbursement Drug List (NRDL); Patent Law; Price negotiation; Real-world evidence (RWE); Regulatory framework; Volume Based Procurement (VBP) (search for similar items in EconPapers)
Date: 2024
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DOI: 10.1007/978-981-97-1471-1_2

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