On January 27, the State Council promulgated the newly revised 'Implementation Regulations of the Drug Administration Law of the People's Republic of China '(hereinafter referred to as the' New Regulations'), which will come into effect on May 15,2026.

This is the first comprehensive revision of the regulation in 23 years since its issuance in 2002, and the first introduction of a 2-year market exclusivity period for pediatric drugs and a 7-year market exclusivity period for orphan drugs.

This revision substantially amended over 90% of the clauses (retaining only the first legislative basis), representing a 'core overhaul' transformation.

The revision of the Regulations adheres to the following overarching principles: First, upholding the principle of putting people and life first, implementing the 'four strictest' requirements for drug safety supervision, and strengthening oversight across the entire supply chain. Second, supporting drug innovation to promote high-quality development of the pharmaceutical industry. Third, maintaining a problem-oriented approach to refine and supplement institutional measures in a targeted manner.

Regarding drug development and registration systems, the Regulations have improved relevant systems in the following aspects: First, supporting clinical value-oriented drug development and innovation, encouraging research and development of new drugs, and supporting the clinical promotion and use of new drugs. Second, strengthening drug development management. The Regulations clarify the qualification certification procedures for non-clinical safety evaluation research institutions, specify management requirements for clinical trials, and establish development management requirements tailored to the characteristics of traditional Chinese medicine. Third, optimizing the drug registration review and approval process. The Regulations establish accelerated procedures such as the Breakthrough Therapy Drug Program, clarify the drug re-registration process, and specify the conversion mechanism for prescription drugs and over-the-counter drugs. Fourth, granting market exclusivity periods for eligible pediatric drugs and orphan drugs, and providing data protection for drugs containing novel chemical components. Fifth, detailing the responsibilities of drug marketing authorization holders.

The Regulations on the Distribution and Use of Drugs have improved relevant systems in the following aspects: First, they enhance the management system for online drug sales by clarifying the responsibilities of third-party online transaction platforms and explicitly prohibiting the online sale of certain drug categories. Second, they strengthen pharmaceutical management in medical institutions to ensure drug quality during use and mitigate risks. Third, they refine the management system for medical institution-prepared drugs.

In terms of drug safety supervision, the Regulations have improved relevant systems in the following aspects: First, they clarify the measures for drug safety inspection and supervision, and specify the circumstances for identifying counterfeit drugs. Second, they detail the procedures for drug quality sampling and testing, stipulating that parties may apply for retesting if they have objections to the test results. Third, they establish strict legal liabilities for illegal acts.

On May 15,2026, when the new Regulations come into effect, China's pharmaceutical industry will usher in a new era with higher innovation incentives, stricter quality standards, and stronger global collaboration. For industry practitioners, only by deeply understanding the logic of the transition from policy declaration to statutory rights can they seize opportunities in compliance and establish long-term competitive advantages in the midst of change.