China’s pharmaceutical market is growing quickly and is now one of the largest in the world. Because of this, drug registration with the China NMPA (National Medical Products Administration) is more important than ever for companies planning to enter or expand in this market.
In 2024, Grand View Research reported the market is worth about USD 80.4 billion and is not slowing down anytime soon. By 2025, it could reach around USD 125.7 billion, with about USD 23.7 billion coming from oncology drugs. Analysts expect the market to grow 5.5% every year from 2025 to 2030, bringing the market close to USD 164.6 billion by the end of the decade. This growth is opening major opportunities for global drug manufacturers to enter or expand in China.
Companies need accurate, well-prepared documentation to move smoothly through the drug registration process. Using professional regulatory translation services ensures every document is clear and consistent, reducing the risk of errors that could cause delays or rejections.
This article breaks down the steps for China NMPA drug registration in simple terms. It covers the key steps, the documents you need, and how precise translations can help you submit a successful application.
Understanding NMPA and Its Role
The National Medical Products Administration (NMPA) is the main body in China that regulates medicines, medical devices, and health products. It works under the State Administration for Market Regulation (SAMR) and makes sure that anything sold in China’s healthcare market is safe, effective, and of high quality.
The China NMPA’s key responsibilities include:
- Reviewing and approving applications for new and generic drugs.
- Allowing and overseeing clinical trials.
- Regulating medical devices, cosmetics, and other health products.
- Monitoring the safety and quality of products after they reach the market.
Its Center for Drug Evaluation (CDE) reviews drug applications. The CDE looks at clinical and non-clinical data to decide if a drug, whether new, generic, or another regulated type, should be approved.
The NMPA follows strict laws, including the Drug Administration Law of the People’s Republic of China and the Provisions for Drug Registration. The Drug Administration Law covers every stage of a drug’s life cycle, from development and registration to manufacturing, distribution, and ongoing safety checks once the drug is on the market.
The Provisions for Drug Registration explain the steps companies must take to get their drugs approved and registered in China. This applies to all types of drugs, including innovative medicines, generics, imports, over-the-counter (OTC) products, biologics, and traditional Chinese medicines.
China updates these laws often, keeping them up to global standards and industry needs. For example, recent changes have reduced review times and introduced fast-track options for drugs that treat rare diseases or address urgent health needs.
For companies entering the Chinese market, understanding the NMPA framework and the laws that guide its operations is critical for a smooth and successful approval process.
Types of Drug Registration Applications
The NMPA offers several pathways for drug registration under the Provisions for Drug Registration. The pathway a company takes depends on the type of product and how it plans to market it in China.
New Drug Application (NDA)
This pathway is for drugs that are new to the Chinese market. It also includes improved versions of existing drugs, such as those with new formulations or additional approved uses.
These applications usually need a large amount of clinical data to prove the drug is safe, effective, and of high quality.
Generic Drug Application
This pathway is for registering generic versions of drugs that have already been approved in China. Companies need to show that their generic version is bioequivalent to the original, meaning it works the same way, is just as safe, and meets the same quality standards.
Instead of running full clinical trials, companies conduct bioequivalence studies, which makes the process faster and less expensive. Many manufacturers choose this pathway to offer more affordable options to the market.
Imported Drug Application
This option is for drugs made outside of China but intended for sale in the country. These applications follow the same rules as domestic ones. The NMPA will classify the application as a new drug or a generic depending on whether the product is already approved in other markets.
Companies must also translate and localize all technical and clinical documents to meet NMPA standards.
OTC Drugs and Others
Over-the-counter (OTC) drugs are products you can buy without a prescription, such as vitamins, basic medications, and traditional Chinese medicines (TCMs). While the process for OTC registration is simpler, companies still need to meet all NMPA rules, especially for packaging and labeling.
Other categories include:
- Improved New Drugs: Updated versions of existing drugs that improve safety or effectiveness.
- Biological Products: Drugs made from living organisms, such as vaccines, antibodies, or gene therapies, that treat, prevent, or diagnose diseases. These must meet the same safety and quality standards as chemical drugs.
- Traditional Chinese Medicines (TCMs): These can be registered as innovative formulas, modified versions, or classic recipes, depending on their ingredients and purpose.
Understanding of these categories helps companies prepare precise applications and progress through the drug approval process smoothly.
Key Steps in the NMPA Drug Registration Process
The China NMPA follows a step-by-step process for drug registration under the Provisions for Drug Registration. Each stage helps ensure that drugs are safe, effective, and high-quality before they reach the market.
1. Pre-Submission Preparation
Before applying, companies gather all the data and documents they need. This includes:
- Completing clinical trials that meet China’s Good Clinical Practice (GCP) standards
- Collecting reliable data on safety, effectiveness, and quality
- Preparing accurate translations and localizations of technical documents to meet regulatory requirements
2. Submission of Application
Applicants then submit their applications with all required documents, such as:
- Clinical trial data and study results
- Manufacturing and quality control details
- Labels and package inserts translated into Chinese
3. Technical Review and On-Site Inspection
The CDE carefully reviews the application. Reviewers check:
- The drug’s safety and effectiveness
- Its quality and manufacturing standards
- Compliance with inspection rules
If needed, the China NMPA may carry out on-site inspections to confirm that facilities and processes meet regulatory standards.
4. Approval and Post-Approval Obligations
Once approved, the NMPA issues a drug registration certificate. After that, companies must:
- Keep labels and packaging up to date and compliant
- Monitor the drug’s safety using proper pharmacovigilance systems
- Submit renewal applications before the certificate expires
Conclusion
To successfully enter China’s pharmaceutical market, companies need a clear understanding of the NMPA framework. Drug approval requires close attention to safety, quality, and documentation at every stage. Staying informed about regulatory updates and local compliance standards can make a big difference, helping companies avoid delays and keep their timelines on track.
Our regulatory translation and life sciences localization services ensure your clinical data, technical files, and labels meet the requirements of both the NMPA and the CDE. With accurate documentation, you can minimize errors, accelerate reviews, and enter the Chinese market faster. Contact us today for expert support with your NMPA submission.
