Presentation (CTI)

OBJECTIVES: In May 2026, amendments to the Implementation Regulations of the Drug Administration Law came into effect in China, including the long-awaited introduction of data exclusivity for innovative drugs and vaccines. As the country shows growing potential to become a leading global hub for drug innovation, the need to strengthen intellectual property protection has increased. The introduction of data exclusivity may be one of China’s efforts to catch up with international practice in this area. This research aims to identify gaps in China’s clinical data protection regime by comparing it with leading international markets, namely the United States, the European Union, Japan, and Australia.
METHODS: An extensive review of data exclusivity regulations in China, the United States, the European Union, Japan, and Australia was conducted using official documents, supplemented by secondary research from GlobalData’s country profile database. A comparative analysis was performed to identify differences in clinical trial data protection practices across the five markets.
RESULTS: China provides six years of data exclusivity for new drugs and four years for modified new drugs, with no additional exclusivity for orphan drugs, biologics, or pediatric indications. China’s exclusivity period is likely shorter than in the European Union and Japan. While the United States provides a slightly shorter exclusivity period for new chemical entities than China, it grants biologic products up to 12 years of data exclusivity, which is substantially longer than in China. Australia provides five years of data exclusivity, which is shorter than China.
CONCLUSIONS: China is advancing regulatory reforms to harmonize with international standards, which is expected to have a positive impact on innovator pharmaceutical companies. However, the new reform does not provide separate data exclusivity provisions for biologics, rare disease therapies, and pediatric drugs. Enforcement of patent protection is another concern that may undermine the reform’s effectiveness.