June 25, 2025

China’s drug market is changing quickly in 2025. The National Medical Products Administration (NMPA) has set new rules to match global standards, support new medicines, and make sure drugs are safe and high quality. For global pharma companies, this means new chances but also new rules to follow.

Main Changes

1. MAH System for All Drugs

  • Every drug must have a Marketing Authorization Holder (MAH).
  • The MAH is responsible for the whole drug life—making, safety checks, and recalls.
  • Foreign firms must work with Chinese partners, but they get more freedom in manufacturing deals.

2. Faster Drug Approvals

  • Special fast track for breakthrough, rare disease, and children’s drugs.
  • Overseas trial data can be used if it meets China’s rules.
  • Rolling submissions help speed up reviews.

3. Real-World Evidence (RWE)

  • RWE can support new uses, updates, and post-market changes.
  • Rules now cover data quality, ethics, and accuracy.
  • This helps lower costs and speed approvals, especially in cancer and rare disease drugs.

4. Digital Submissions (eCTD)

  • From 2025, all drug applications must be in eCTD digital format.
  • This makes reviews faster, cleaner, and globally aligned.

5. Stricter Drug Safety Rules (PV)

  • Risk plans, real-time safety reports, and frequent checks are required.
  • Breaking rules can mean heavy fines.
  • Strong local safety systems are necessary.

6. Global Standards Alignment

  • China is quickly adopting global standards (GMP, GCP, GLP).
  • This avoids duplicate trials and brings faster global recognition.

7. Cell & Gene Therapy Pathways (CGT)

  • New clear rules, fast-track reviews, and special teams for CGTs.
  • Faster and safer way for advanced therapies.

How Companies Should Get Ready

  • Stay Informed: Follow NMPA updates.
  • Prepare Documents: Use eCTD, good RWE, and safety files with accurate data.
  • Work with Locals: Partner with Chinese CROs, safety teams, and manufacturers.
  • Set up Safety Systems: Build PV systems in China for quick reporting and risk control.

Final Word

2025 is a big year for China’s pharma market. Digital systems, global standards, and innovation-friendly rules will shape the future. Companies that prepare early, follow the rules, and build strong local ties will succeed. Maven can guide you to stay compliant and grow in this fast-changing market.