China updates regulations for implementing the Medicines Regulation Law
Commences on May 15, 2026
The State Council of the People's Republic of China has approved new Implementing Regulations for the Law on Drug Administration—the first comprehensive update in more than 20 years. The document covers the entire life cycle of a drug: from development and clinical trials to production, distribution, and pharmacovigilance.
What has changed systemically?
Previously, many accelerated and innovative mechanisms operated on the basis of secondary legislation and internal regulatory procedures. Now they are enshrined in mandatory administrative rules, which increases legal certainty and predictability for developers.
- Accelerated regulatory tracks are enshrined in law
Four mechanisms have been officially included:
- Breakthrough Therapy — support for the development of drugs with significant clinical advantage
- Priority Review — priority review of the registration dossier
- Conditional Approval — conditional approval in the presence of preliminary efficacy data
- Special Approval — a special procedure (including emergency situations)
The mechanisms were used previously, but have now received regulatory approval Consolidation.
2. Exclusivity and Innovation Protection
For the first time, incentives for innovative drugs have been directly established:
- Up to 7 years of market exclusivity — for drugs for rare diseases
- Up to 2 years of exclusivity — for pediatric drugs
- Up to 6 years of clinical data protection (data exclusivity)
A condition for orphan exclusivity is ensuring a stable supply to the Chinese market.
This strengthens the economic model for investment return and increases the investment attractiveness of the Chinese market.
3. Recognition of Foreign Clinical Data
The ability to use international clinical trial data for registration in China has been established (subject to quality and reliability requirements).
This reduces the need for duplicating studies and simplifies the synchronous global launch of drugs.
4. Strengthening MAH Responsibility
The Marketing Authorization Holder is responsible for:
- quality control at all stages
- pharmacovigilance
- risk management
- product recall, if necessary
Foreign MAHs are required to appoint a legal representative in China.
5. Quality Control and Handling
Strengthened requirements for:
- Contract and segmented manufacturing
- Online drug sales
- Retesting and surveillance procedures
What does this mean for orphan drugs
- 7-year exclusivity creates an incentive comparable to the EU for the withdrawal of orphan drugs
- Accelerated tracks increase the likelihood of faster patient access to innovative therapies
- Recognition of foreign data simplifies global registration strategies
China is strengthening its position as a key global market for innovative and orphan developments.
Source: Morgan Lewis - Navigating China’s New 2026 Implementing Regulations of the Drug Administration Law
