BEIJING – On May 15, 2026, China’s revised Implementation Regulations of the Drug Administration Law(State Council Decree No. 828) took effect, drawing close attention from multinational pharmaceutical companies.

The update introduces Western-style incentives, including up to six years of data protection for novel drugs, seven years of market exclusivity for orphan drugs, and two years for pediatric drugs. It also formally accepts overseas clinical data for domestic filings and codifies accelerated approval pathways.

However, the rules impose stricter compliance burdens: Marketing Authorization Holders (MAHs) importing drugs into China must establish independent quality management systems, and all products are subject to a national "one-item-one-code" traceability mandate. The move signals China’s dual approach of incentivizing innovation while tightening post-market oversight.

Information Sources

Revised Implementation Regulations of the Drug Administration Law Enforced May 15, Strengthening MAH Liability and Innovation Incentives

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