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China continues to reshape its pharmaceutical Regulatory landscape through modernization, digitalization, and global alignment. In a recent set of major announcements by the National Medical Products Administration (NMPA), significant changes were introduced, ranging from the expansion of eCTD submissions, the release of the 2025 edition of the Chinese Pharmacopoeia, to the approval of several high-priority innovative drugs.

Together, these reforms are more than policy updates—they are a signal of how pharmaceutical engagement in China is evolving at both strategic and operational levels.

1. eCTD Scope Expansion

Through Announcement No. 10, released on Jan 23, 2025, the NMPA expanded the use of the electronic Common Technical Document (eCTD) to cover additional application types, starting January 27, 2025. The scope now includes:

  • Clinical Trial Applications (CTAs) for chemical drugs (Classes 1–5)
  • Marketing Authorization Applications (MAAs) for chemical drugs (Classes 2, 3, 4, and 5.2)
  • CTAs for biological products (Classes 1–3)
  • MAAs for preventive biological products and biological products (Classes 2 and 3)

Why This Matters:

  • Faster and more efficient submissions: Streamlined documentation and automation reduce approval timelines.
  • Improved traceability and lifecycle tracking: Structured formats make Regulatory oversight more robust.
  • Global alignment: Adopting eCTD brings China in line with ICH, FDA, and EMA Regulatory systems.

2. Chinese Pharmacopoeia Update

The 2025 edition of the Pharmacopoeia of the People’s Republic of China was formally issued on Mar 20, 2025, and will take effect starting October 1, 2025. The update was jointly released by the NMPA and the National Health Commission through Announcement No. 29.

Key Enhancements:

  • Updates across chemical drugs, biologics, and Traditional Chinese Medicine (TCM)
  • Enhanced analytical methods and testing standards
  • Tighter quality control protocols for manufacturing and post-approval monitoring

For global pharmaceutical companies, the update underscores the need for method validation, analytical consistency, and GMP-aligned manufacturing documentation.

3. New Drug Approvals Reflect Strategic Focus

In 2025, new drug approvals in China, particularly by the National Medical Products Administration (NMPA), are reflecting a strategic focus on addressing specific disease areas and embracing Regulatory advancements. 

The focus areas include oncology, hematology, and infectiology, with a growing emphasis on innovative therapies for unmet medical needs like rare diseases and pediatric populations. 

Regulatory reforms, including the acceptance of real-world evidence and priority review pathways, are accelerating the approval process for these high-impact therapies. 

4. Focus on Quality Oversight

On June 9, 2025, the NMPA convened its annual Quality Management System (QMS) review, focusing on 2024 performance outcomes in pharmaceutical manufacturing. The review addressed:

  • Identifying the deficiencies and CAPAs, as well as the recommendations for improvement.
  • Deepening the effective operation of vaccine QMS, coordinate and promote the smooth start of pharmaceutical QMS.
  • Enhance the capacity of pharmaceutical inspection,  adhere to the whole-process management.
  • In line with international standards, promote the improvement of drug Regulatory capabilities through a sound Regulatory quality system.

The outcomes of this review are expected to shape upcoming guidance documents and deepen compliance expectations across the pharmaceutical sector.

Why This Matters for Pharmaceutical Companies

As the world’s second-largest pharmaceutical market, China is no longer just a commercial destination—it’s becoming a Regulatory leader. These recent reforms highlight four critical shifts:

  1. Digital-by-default operations: With expanded eCTD mandates, companies must modernize their submission infrastructure.
  2. Higher quality benchmarks: Pharmacopoeial updates demand tighter control of analytical and manufacturing processes.
  3. Accelerated innovation: Accelerated pathways are becoming more accessible for both local and global firms.
  4. Enforcement-driven QMS culture: Proactive preparedness is essential to navigate evolving GMP and post-market surveillance standards.

Companies aiming to succeed in China must now balance compliance readiness, strategic agility, and local-market adaptation.

Looking to align with China's new Regulatory direction?
Get in touch with Freyr’s global Regulatory experts today and stay compliant, competitive, and future-ready.