Top 12 Frequently Asked Questions About Drug Regulatory Affairs in China

China’s pharmaceutical market has become both highly attractive and increasingly complex. With continuous reforms from the National Medical Products Administration (NMPA), the country is steadily aligning with global standards. For regulatory professionals and multinational companies, understanding the latest requirements is essential for successful product entry and long-term compliance.

Below are 12 frequently asked questions (and answers) that capture the current regulatory landscape in China.

1. What does the current drug approval pathway in China look like?

The NMPA’s approval process involves several key steps:

• IND (Investigational New Drug) submission

• Clinical trial authorization

• NDA (New Drug Application) / BLA (Biologics License Application) filing

• CDE (Center for Drug Evaluation) technical review

• GMP inspections and quality testing

Recent reforms and expedited review programs have shortened timelines considerably.

2. Can foreign clinical trial data be accepted in China?

Yes. The NMPA now accepts overseas clinical data, especially from ICH regions. However, bridging studies or China-specific trials may still be needed, depending on the therapeutic area and ethnic sensitivity of the product.

3. What expedited approval programs are available?

China currently offers four fast-track options:

• Priority Review

• Conditional Approval

• Breakthrough Therapy Designation

• Special Review

These pathways apply to drugs addressing serious or rare conditions, unmet needs, or those already approved abroad but not yet available in China.

4. How does China’s Drug Master File (DMF) system work?

The DMF process applies to APIs, excipients, and packaging materials. Manufacturers must submit their DMF to the CDE to receive a reference number, which applicants then cite during product registration. China-specific formatting and procedural rules apply, differing from the U.S. and EU.

5. Are local clinical trials always required for NDAs?

Not always. If overseas data (particularly from MRCTs including Chinese patients) is robust, the requirement may be waived. However, local studies are often mandatory for products with high ethnic sensitivity or novel indications.

6. How are drugs classified under NMPA rules?

• Category 1: Innovative chemical drugs never marketed globally

• Categories 2–5: Improved drugs, generics, and imported products

• Biologics: Classified separately into therapeutic and preventive types

• Traditional Chinese Medicines (TCM): Registered via classic formula or innovative pathways

7. What GMP and GCP standards must foreign manufacturers meet?

China requires full GMP and GCP compliance, consistent with ICH guidelines. Key expectations include:

• Risk-based inspections for overseas sites

• Appointment of a local Qualified Person (QP) or regulatory contact

• Pharmacovigilance (PV) obligations for the Marketing Authorization Holder (MAH)

8. What post-market obligations apply?

MAHs must ensure:

• Pharmacovigilance reporting (ADR reports, PSURs, signal detection)

• Variation submissions for product, process, or packaging changes

• Ongoing GMP compliance and re-inspections

9. How are biologics and biosimilars regulated?

Biologics follow a specialized NDA process. For biosimilars, China requires:

• Comparability studies

• PK/PD data

• At least one confirmatory Phase III trial

Current guidelines (2020 onward) align closely with EMA/FDA standards, though with China-specific requirements.

10. What is the regulatory pathway for Traditional Chinese Medicines (TCM)?

• Classic Formula (CTCMF): Minimal trial data required

• Innovative/New TCM: More rigorous evidence and studies required

All TCMs must demonstrate ingredient traceability, consistent formulation, and proven safety.

11. What are the major challenges for foreign MAHs?

Key hurdles include:

• Adapting to frequent regulatory updates

• Preparing China-specific eCTD Module 1

• Meeting Chinese-language documentation needs

• Appointing a local legal representative

• Navigating pricing, reimbursement (NRDL), and tendering systems

• Managing patent linkage and exclusivity issues

12. What is China’s centralized procurement system?

Known as the “4+7” volume-based procurement program, it impacts market access by:

• Requiring bioequivalence (BE) compliance

• Selecting only a few suppliers per molecule

• Driving steep price reductions in exchange for large guaranteed volumes

While it pressures margins, successful bidders gain significant market share rapidly.

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