Navigating China’s New 2026 Implementing Regulations of the Drug Administration Law

The State Council of the PRC promulgated the Implementing Regulations of the Drug Administration Law (2026 Revisions) on January 27, 2026, set to take effect on May 15, 2026. This LawFlash provides a summary of the law and analyzes the strategic impact these shifts will have on foreign investors and multi-national pharmaceutical enterprises operating in the Chinese market.

The 2026 Revisions represent a strategic move by the Chinese government to unify and elevate drug governance. By consolidating rules previously dispersed across various departmental measures and guidelines from the National Medical Products Administration (NMPA) and the State Administration for Market Regulation (SAMR), this update creates a cohesive, legally binding framework governing the entire drug lifecycle—from research and development (R&D) and registration to manufacturing, sales, and post-market supervision.

Crucially, the 2026 Revisions align China’s regulatory regime more closely with international practices, introducing pivotal changes to market exclusivity, supply chain flexibility, and accelerated approval pathways.

CHANGE OF CLINICAL TRIAL SPONSOR

The 2026 Revisions formally codify a 20-working-day review period for applications to change a clinical trial sponsor. This statutory timeline provides significantly greater predictability for BD transactions, such as licensing deals and mergers, where the transfer of trial sponsorship is a critical closing milestone.

Historically, this procedure was governed primarily by departmental rules and technical guidelines focused on administrative formalities. Specifically, the Measures for the Administration of Drug Registration issued by the SAMR in January 2020 mandated a joint application by both the incumbent and successor sponsors to the NMPA during the trial phase, with operational details relegated to the technical guidance of the Center for Drug Evaluation of the NMPA.

By elevating this process into a formal administrative regulation with a fixed review window, the 2026 Revisions reduce regulatory uncertainty and streamline the transition of R&D responsibilities between commercial partners.

ACCELERATED APPROVAL PATHWAYS

The 2026 Revisions formally codify the four "green channels" for drug registration, including Breakthrough Therapy, Conditional Approval, Priority Review, and Special Approval, elevating these pathways from departmental measures to the level of administrative regulations.

By reaffirming the framework established in the Measures for the Administration of Drug Registration, this codification provides stronger legal certainty and aligns China’s entry barriers with international standards. For innovative pharmaceutical companies, this means a more predictable and expedited route to market for drugs with significant clinical value, effectively bridging the gap between R&D breakthroughs and patient access.

ACCEPTANCE OF OVERSEAS DATA

The 2026 Revisions provide a robust statutory foundation for the utilization of overseas clinical trial data in domestic drug registrations, elevating a practice previously governed by the 2018 Guiding Technical Principles issued by the former China Food and Drug Administration. By formalizing this mechanism at the administrative regulation level, the new framework offers greater legal certainty for multi-national pharmaceutical companies seeking to leverage global R&D investments.

Provided that the data fulfills NMPA requirements regarding ethnic consistency and data integrity, this provision facilitates deeper global R&D integration. It minimizes redundant clinical trials within China and synchronizes China launches with global markets.

MARKET EXCLUSIVITY AND DATA PROTECTION

The 2026 Revisions introduce formal market exclusivity periods to incentivize innovation in critical therapeutic areas, specifically for pediatric medicines and orphan drugs:

• Pediatric Medicines: Eligible new pediatric drugs—including those with novel dosage forms, specifications, or expanded pediatric indications—may be granted a market exclusivity period of up to two years, provided they meet regulatory criteria.
• Orphan Drugs: For eligible treatments of rare diseases, a market exclusivity period of up to seven years may be granted. This is contingent upon the Marketing Authorization Holder (MAH) committing to a guaranteed drug supply. Notably, this exclusivity will terminate prematurely if the MAH fails to fulfill its supply obligations.

In addition, the 2026 Revisions strengthen data exclusivity by offering up to six years of protection for undisclosed trial data of drugs with novel chemical entities, as per existing regulations, and extend this protection to other eligible drugs. This measure prevents competitors from unfairly using a pioneer’s proprietary data for generic approvals without explicit authorization, thereby safeguarding the intellectual property of innovative manufacturers.

RESPONSIBILITIES OF MAH

The 2026 Revisions introduce a dedicated chapter that establishes a comprehensive regulatory framework for MAH responsibilities, emphasizing accountability throughout the drug's entire lifecycle.

Full Lifecycle Responsibility

The Revisions reaffirm that the MAH bears ultimate responsibility for the entire lifecycle of a drug—from R&D and registration to manufacturing, distribution, and post-market surveillance. Key obligations include the following:

• Quality Governance: MAHs must maintain a robust quality assurance system, overseen by an independent quality management department and led by designated key personnel (e.g., Production Head, Quality Head, and Quality Authorized Person).
• Pharmacovigilance (PV): MAHs are mandated to implement a comprehensive PV system to monitor adverse reactions and establish rigorous risk identification and control mechanisms.
• Manufacturing Oversight: Any changes to the manufacturing process must be rigorously evaluated and validated. Depending on the risk level, MAHs must submit supplemental applications, filings, or reports for regulatory approval.
• Post-Market Evaluation: MAHs must continuously monitor quality and efficacy. Based on post-market data, they are required to take proactive measures such as labeling revisions, process optimizations, product recalls, or even voluntary registration cancellations. Failure to fulfill these obligations may result in the denial of drug reregistration.

Domestic Responsible Person for Foreign MAHs

The 2026 Revisions reiterate that the foreign MAHs responsibilities to appoint a China-based responsible entity to fulfill regulatory obligations and bear joint and several liability with the foreign MAH for drug quality and safety, following the requirements of the Interim Provisions on the Administration of the Domestic Responsible Person Designated by Foreign Marketing Authorization Holders, issued by NMPA on November 13, 2024. (For more details, please refer to our previous LawFlash: China Issues New Domestic Responsible Person Rules for Foreign Drug Marketing Authorization Holders.)

SUPPLY CHAIN FLEXIBILITY: SEGMENTED & CONTRACT MANUFACTURING

In a significant shift, the 2026 Revisions formally permit “segmented production”—allowing different manufacturing stages to be conducted at different sites—for innovative drugs or those in urgent clinical need. This provision enables foreign MAHs to adopt more flexible supply chain strategies, such as partnering with local CMOs for specific production segments. This marks a major step forward in facilitating the localized manufacturing of foreign-innovated therapies. (For a deeper dive into the localized manufacturing regime, see our LawFlash: China Boosts Regulatory Framework for Local Pharmaceutical Manufacturing.)

PREAPPROVAL BATCH SALES

The 2026 Revisions permit the sale of commercial-scale batches produced before approval once marketing authorization is granted.

This applies to products that have passed corresponding Good Manufacturing Practice compliance inspections or, for new drugs, rare disease treatments, short-supply drugs, and other urgently needed clinical drugs, to commercially produced batches after passing GMP compliance inspections. MAHs must strengthen risk management for drugs marketed under these provisions. This fills in the gap of the legal basis, accelerates patient access to life-saving medications, and provides increased legal certainty for global manufacturers regarding investments in China.

LOOKING AHEAD

The 2026 Revisions mark a definitive milestone in China’s journey toward a fully integrated, lifecycle-based regulatory framework. By unifying oversight across R&D, registration, manufacturing, and post-market surveillance, the 2026 Revisions provide a more transparent roadmap that harmonizes China’s drug administration with international best practices.

As the industry prepares for the May 15, 2026 effective date, this transition signifies more than just stricter compliance; it opens doors for enhanced supply chain flexibility and provides long-sought legal certainty for market exclusivity and preapproval manufacturing. We anticipate that this “master regulation” will soon be followed by a wave of detailed implementation rules and technical guidelines from the NMPA, further clarifying the operational paths for both domestic and multi-national pharmaceutical players.