China Announces the Implementing Regulation of the Drug Administration Law

The 2026 revision of the Implementing Regulation of the Drug Administration Law, effective May 15, 2026, was recently passed by China’s State Council. The revision adds a dedicated chapter on Marketing Authorization Holder (“MAH”), expands data and market exclusivity, enables contract and segmented manufacturing with tighter oversight, permits certain post-approval sales of pre-approval commercial-scale batches, and links post-market evaluations to re-registration outcomes.

MAH Chapter on Lifecycle Accountability

The 2026 revision adds a dedicated chapter that centers lifecycle accountability on MAHs. MAHs must maintain a comprehensive quality system, establish an independent quality management department, and designate a production lead, a quality lead, and a “quality authorized person” responsible for independent batch release.

MAHs must also implement a pharmacovigilance (“PV”) system aligned with Good Pharmacovigilance Practices, with cooperation from distributors and medical institutions. Overseas MAHs must appoint a qualified China enterprise legal person and disclose the agent in the package insert; MAHs must also ensure accessible labeling and e-IFUs with legal equivalence to approved paper content.

Expansion of Data Exclusivity and Market Exclusivity

The revision introduces market exclusivity of up to two years for qualifying pediatric medicines and up to seven years for qualifying rare disease drugs subject to an MAH supply commitment; exclusivity may terminate if supply is not maintained. Protection for undisclosed CMC and clinical study data in relation to new chemical entities and other pharmaceutical products is reaffirmed for up to six years from registration. The National Medical Products Administration (“NMPA”) will issue detailed requirements for rolling out the market exclusivity and data exclusivity periods. R&D-based pharmaceutical companies may benefit further from the expansion of data exclusivity and market exclusivity when introducing their products to China.

Contract and Segmented Manufacturing

The revision allows “segmented production” for innovative drugs with special process/equipment needs and for urgent clinical, public health emergency, or stockpiling needs, subject to a unified MAH quality system across all sites.

Sale of Post-Approval Commercial-Scale Batch Sales

The revision permits certain commercial-scale batches produced pre-approval to be sold after approval if they pass GMP compliance checks, including for new drugs, rare-disease drugs, drugs in shortage, and other clinically urgent drugs. MAHs bear responsibility for strengthened risk management when using this pathway.

Post-Market Evaluation Requirements Tied to Drug Re-Registration

Post-market evaluation is explicitly linked to re-registration success of drug products. MAHs must continuously assess quality, efficacy, and adverse reactions and conduct periodic evaluations that analyze benefit-risk and implement actions such as label updates, standard upgrades, process improvements, suspension, recalls, or voluntary deregistration. Failure to perform ongoing assessments or required evaluations may result in non-renewal at expiry.

The 2026 revision has no express grace period. MAHs should examine their readiness for QMS and PV obligations, supplier governance for contract/segmented manufacturing, and protocols for post-approval sales of pre-approval commercial-scale batches before the revision’s effective date.

Katherine Wang, Partner, Ropes & Gray