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2 min read
China’s pharmaceutical market is one of the largest and fastest growing in the world, offering immense opportunities for global manufacturers. However, entering this market requires a deep understanding of the National Medical Products Administration (NMPA) Regulatory framework. The process of drug registration in China can be complex, especially for companies unfamiliar with local compliance requirements.
To make it easier, we’ve answered some of the most frequently asked questions (FAQs) about registering drugs in China.
1. Who regulates drugs and medicinal products in China?
The National Medical Products Administration (NMPA) is the key regulatory authority in China. It oversees the review, approval, and monitoring of drugs, medical devices, and cosmetics.
2. Is a Local Representative (LR) required for foreign manufacturers?
Yes. Foreign companies cannot directly register their products. A China Local Representative (China LR) is mandatory to act as the regulatory liaison with NMPA, submit applications, and manage post-approval compliance.
3. What submission format does China follow?
China mandates the electronic Common Technical Document (eCTD) format for drug submissions. Since 2021, eCTD has been compulsory, and any errors in formatting, Module 1 localization, or missing data can cause significant delays.
4. Are clinical trials required for drug registration in China?
- Local clinical trial data may be required unless an exemption applies.
- China may accept overseas clinical data, but bridging studies are often requested.
- NMPA reviews requirements on a case-by-case basis depending on the drug type.
5. How long does the drug registration process take in China?
Official review timelines are as below:
- Standard review procedure: 200 workdays
- Priority Review Procedure: 130 workdays
- Priority Review Procedure for drugs which are marketed overseas with clinical urgent need for rare diseases: 70 workdays
- Generic API alone: 200 workdays
The marketing authorization approval timelines depend on dossier quality, GMP inspections, and NMPA responses.
6. What are the GMP requirements for manufacturers?
All manufacturing facilities must comply with China GMP standards. NMPA may conduct on-site GMP inspections or request certificates from international authorities (FDA, EMA, etc.) to verify compliance.
7. What are the labeling and packaging requirements?
Drug labeling must be in Simplified Chinese and include product name, manufacturer details, dosage, administration, contraindications, and safety warnings, etc. with NMPA format. Non-compliant labeling can result in delays or recalls.
8. What are the pharmacovigilance (PV) requirements post-approval?
- A local PV contact is mandatory for adverse event reporting.
- Serious adverse events (SAEs) must be reported within 15 calendar days.
- ICSRs shall be reported within 30 calendar days.
- It should be reported within 24 hours for suspension of sales, use or withdrawal from market required by regulatory authority due to safety concerns.
- Periodic Safety Update Reports (PSURs) must be submitted as per NMPA guidelines.
9. Are approvals from US FDA or EMA recognized in China?
No. While FDA or EMA approvals are not directly recognized, they may faciliate the approval process depending on the drug characteristics, e.g. medical need, clinical data bridging, etc.
10. What are the most common reasons for drug registration delays in China?
- Incomplete or inconsistent documentation
- Non-compliant eCTD submissions
- Lack of an authorized Local Representative
- GMP deficiencies
- Delayed responses to NMPA queries
Final Thoughts
The drug registration process in China can be challenging, but with the right guidance and compliance strategy, manufacturers can successfully enter this booming market. Understanding NMPA expectations, eCTD requirements, and pharmacovigilance obligations is crucial for a smooth approval process.
Partner with Freyr Solutions – With our expertise in China drug registration, NMPA submissions, eCTD publishing, and Local Representation (LR) services, we help global pharmaceutical companies achieve faster, compliant, and hassle-free market entry in China.
Get in touch with our experts today to discuss your China Regulatory needs.
