,
2 min read
China’s pharmaceutical Regulatory landscape continues to evolve rapidly. In December 2025, the National Medical Products Administration (NMPA) introduced a new policy aimed at significantly reducing the time between drug approval and market supply in China. This reform is expected to play a critical role in China’s drug approval and commercialization strategies in 2026, particularly for innovative, urgently needed, and globally developed medicines.
What Is the New NMPA Policy?
Traditionally, pharmaceutical companies in China experienced a delay between receiving marketing authorization from the NMPA and being able to supply approved drugs to the market. This delay was largely driven by post-approval manufacturing, importation, and batch release requirements.
Under the new policy, commercial-scale batches of drugs that are already marketed overseas can be imported and supplied earlier in China, provided the product has received NMPA approval and fully complies with Good Manufacturing Practice (GMP) and the approved Chinese registration dossier. This allows companies to better align Regulatory approval with commercial supply readiness.
Products Covered Under the Policy
The policy focuses on products that are strategically important to China’s healthcare system, including:
- Innovative and modified drugs approved in China and overseas
- Urgently needed medicines and drugs listed for shortage prevention
- Rare disease and pediatric drugs, where early access is critical
- Products previously supplied through temporary import programs that later receive full NMPA approval
Importantly, while timelines are shortened, Regulatory standards remain stringent, ensuring continued focus on quality, safety, and compliance.
Why This Policy Is Especially Important for China in 2026
As China enters 2026, this policy becomes increasingly significant for several reasons:
- Growth in China’s innovation pipeline: China is approving more innovative and first-in-class drugs than ever before. A faster transition from approval to supply will be essential to manage launch volumes efficiently.
- Rising patient demand: Aging demographics, chronic disease prevalence, and expanded rare disease coverage are increasing demand for rapid access to new therapies.
- Global launch alignment: Multinational companies are prioritizing synchronized global launches. Reducing post-approval delays in China helps maintain competitiveness in one of the world’s largest pharmaceutical markets.
- Supply chain resilience: Earlier supply readiness supports better inventory planning and reduces the risk of post-approval shortages.
In 2026, companies that do not proactively plan for CMC readiness, batch comparability, and import compliance may face avoidable delays despite receiving Regulatory approval.
What This Means for Pharmaceutical Companies in China
While the policy creates opportunities for faster market access in China, it also increases expectations around regulatory preparedness, dossier accuracy, and supply coordination. Manufacturers must ensure that overseas commercial batches are fully aligned with China-approved specifications and documentation.
How Freyr Supports Faster Drug Market Access in China
Freyr helps pharmaceutical companies successfully navigate China’s evolving Regulatory framework by providing:
- China-specific Regulatory and launch readiness strategies
- CMC and dossier alignment for early supply eligibility
- Support for importation planning and NMPA compliance
- End-to-end NMPA submissions and lifecycle management
- Local Representation (LR) and post-approval Regulatory support
Planning a drug launch or approval strategy in China for 2026? Connect with Freyr’s China Regulatory experts to reduce time-to-market, ensure compliance, and achieve faster, confident market access.
