China Revises Pharmaceutical Regulations, Strengthening Protection for Drug Innovation

Release Time：2026-02-03 11:28Author：Views：71

On December 31, 2025, the State Council adopted the revised Implementing Regulations of the Drug Administration Law of the People’s Republic of China at its 76th executive meeting. The modified regulations, announced on January 27, will take effect on May 15, 2026. This is the first comprehensive revision in over twenty years since the regulation came into effect.

The revision aims to strengthen the protection of pharmaceutical intellectual property and encourage sustained innovation.

The new regulations, for the first time, formally introduce market exclusivity for pediatric and rare disease drugs:

l Eligible pediatric drugs will be granted a market exclusivity period of up to 2 years.

l Eligible drugs for rare disease treatment will be granted a market exclusivity period of up to 7 years.

It tackles the long-standing dilemma of "high investment, long cycles, and low returns" in developing these drugs, as well as strengthens companies' motivation for research and development, provides more enduring market protection for innovative drugs upon market entry, thereby effectively extending the product life cycles and enhancing their commercial value.

Furthermore, the regulations provide protection for eligible pharmaceutical trial data and other relevant data. The protection period for such data shall not exceed 6 years from the date of drug registration. During the protection period, other applicants are not permitted to directly rely on this undisclosed data to apply for drug registration applications without authorization, except where they submit data obtained independently. The previous regulations lacked defined timeframes and enforceable prohibitions, offering minimal substantive protection. The revised regulations address this gap by instituting clear, operational legal clauses that form a robust legal shield.

The revision of the Implementing Regulations of the Drug Administration Law provides robust safeguards for innovative pharmaceutical companies. Simultaneously, it sets a higher threshold for drug approval, compelling the generic drug industry to develop towards higher technological sophistication. This move is designed to incentivize high-quality pharmaceutical innovation and foster a more efficient pharmaceutical ecosystem.

Source: https://www.mee.gov.cn/zcwj/gwywj/202601/t20260128_1142757.shtml

Previous：Major Overhaul of China's Foreign Trade Law: Comprehensive Strengthening of IP Protection and Implications for Global Business

Next：EU Proposed European Biotech Act：Accelerating the Commercialisation of IP

Return to List