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3 min read
China has rapidly evolved into one of the most complex but also opportunity-rich pharmaceutical markets in the world. With reforms from the National Medical Products Administration (NMPA) aligning closely with global standards, it's no surprise that Regulatory professionals worldwide are eager to understand the rules of engagement.
Whether you’re a multinational planning to enter China or a Regulatory strategist keeping pace with changes, these are the 12 most commonly asked questions about medicinal product regulations in China, answered with up-to-date insights.
1. What is the current drug approval process in China under the NMPA?
China’s drug approval pathway includes:
- IND (Investigational New Drug) submission
- Clinical trial approval
- New Drug Application (NDA) or Biologics License Application (BLA) submission
- Technical reviews by the CDE (Center for Drug Evaluation)
- GMP compliance inspections
- Quality-control test
Thanks to recent reforms, review timelines have shortened, especially for drugs under expedited programs.
2. Can overseas clinical trial data be used for drug registration in China?
Yes. China now allows the use of overseas clinical trial data, particularly from ICH countries. However, depending on the disease area and population sensitivity, bridging studies or local trials may still be required.
3. What are China’s fast-track approval pathways?
The NMPA offers four major expedited pathways:
- Priority Review
- Conditional Approval
- Breakthrough Therapy Designation
- Special Review
These programs are applicable to drugs that:
- Address serious conditions with unmet medical needs
- Are clinically innovative
- Have been approved abroad but not yet in China
4. What is the DMF (Drug Master File) process in China?
China’s DMF system applies to:
- APIs
- Excipients
- Packaging materials
Manufacturers must submit their DMF to the CDE and obtain a reference number. The applicant must actively reference this DMF during the product registration. Unlike the U.S. or EU, China-specific formats and procedural nuances apply.
5. Are local clinical trials mandatory for NDAs in China?
Not always. If robust overseas data is available—especially from multi-regional clinical trials (MRCTs) that include Chinese participants—local trials may be waived. However, China-specific trials are often still required for drugs with high ethnic sensitivity or novel indications.
6. How are drugs classified under the NMPA?
NMPA categorizes drugs into:
- Category 1: New chemical entities never marketed globally
- Category 2–5: Include improved new drugs, generics, and imported products
- Biologics: Classified separately into therapeutic and preventive
- Traditional Chinese Medicine (TCM): Registered via classic or simplified pathways
7. What are the GMP and GCP expectations for foreign manufacturers?
China expects full GMP (Good Manufacturing Practices) and GCP (Good Clinical Practices) compliance, aligned with ICH guidelines.
- Foreign manufacturing sites may undergo risk-based inspections.
- A Local Qualified Person (QP) or regulatory contact is often required.
- Pharmacovigilance responsibilities also fall on the Marketing Authorization Holder (MAH).
8. What are the post-market obligations in China?
MAHs are responsible for:
- Pharmacovigilance (PV): Including ADR reporting, PSUR submissions, and signal detection
- Change control notifications to NMPA for variations in product, process, or packaging
- Re-inspections and ongoing compliance with GMP and quality standards
9. How are biosimilars and biologics regulated in China?
Biologics follow a distinct NDA path, with detailed technical and clinical requirements. For biosimilars, China mandates:
- Comparability exercises
- Pharmacokinetic (PK)/pharmacodynamic (PD) studies
- At least one confirmatory Phase III trial
Guidelines introduced in 2020 align closely with EMA and FDA standards but still carry China-specific requirements.
10. How are Traditional Chinese Medicines (TCM) regulated?
TCM products can be registered under:
- Classic formula pathway (CTCMF) – minimal clinical trials required
- Innovative/new TCM route – more rigorous evidence needed
All TCM products must prove:
- Ingredient traceability
- Consistent formulation
- Historical or clinical safety
11. What are the Regulatory challenges for foreign MAHs entering China?
Key hurdles include:
- Optimizing regulatory strategy in line with the dynamic evolving regulatory policies and system
- Localized documentation (especially Module 1 of the eCTD format)
- Language requirements
- Appointing a Local Legal Representative
- Navigating the pricing, reimbursement (NRDL), and tendering systems
- IP and exclusivity protections, including China’s evolving patent linkage system
12. What is China’s centralized procurement system and how does it impact market access?
China’s "4+7" volume-based procurement policy has transformed drug pricing and access. To qualify:
- Drugs must meet bioequivalence (BE) standards
- Only a few suppliers are selected per molecule
- Significant price cuts are expected in exchange for volume guarantees
This model puts cost pressure on MAHs but ensures rapid uptake if selected.
Final Thoughts
China's pharmaceutical Regulatory landscape is evolving rapidly, offering significant potential for companies that understand the system. Whether you're preparing an IND, navigating CMC expectations, or strategizing market access, staying ahead of NMPA updates and localized requirements is critical.
Need help navigating China’s Regulatory maze? Freyr offers end-to-end Regulatory consulting for product registration, NMPA interactions, clinical strategy, and post-market compliance.
Let’s talk Book a consultation to explore how we can support your China strategy.
