Guest Column | October 6, 2025

Import Product Specifications And Drug Registration Testing For China

China has become a significant market for biopharmaceutical products and possesses huge commercial opportunities. Its regulations on drugs and medical devices have gone through substantial reforms since 2015. In 2017, the China Food and Drug Administration (CFDA) became a regulatory member of the International Council for Harmonisation (ICH) and began to bring international standards into drug regulation in China. Significant changes have been made that aim to harmonize with ICH requirements, create a faster review and approval timeline, and promote innovative and simultaneous drug development.

Nevertheless, the Chinese regulatory requirements, marketing authorization application, and approval process have unique elements that are complex and challenging.

This article provides a high-level introduction to the National Medical Products Administration’s (NMPA, formerly known as CFDA) guidance on import product specifications for biologics products and drug registration testing, followed by an overview of current challenges and recommendations.

Import Product Specifications And Drug Registration Testing

According to China’s Drug Registration Regulation, the NMPA is in charge of the administration of drug registration in China, establishing drug registration administration systems and regulations, and formulating drug registration administration practice. The Center for Drug Evaluation (CDE) in the NMPA evaluates and approves drug registration for clinical trial applications, marketing authorization applications, supplementary applications, and renewal applications of drugs.

After completing studies including chemistry, manufacturing, and controls (CMC), pharmacological and toxicological studies, and drug clinical trials supporting the drug marketing registration, establishing specifications, and completing commercial-scale manufacturing process validation and preparation for drug registration inspection and testing, the applicant can file a drug marketing authorization application (i.e., new drug application or NDA) and submit related study data as per application dossier requirements in China. The application can be accepted when the application dossiers comply with requirements and pass the administrative check by the CDE. The CDE then conducts a comprehensive review of the application dossiers and issues a registration certificate at the conclusion of the review if approved.

Furthermore, the Drug Registration Regulation requires drug registration testing, which is conducted by the National Institutes for Food and Drug Control (NIFDC) and its associated testing institutions.

The principles, procedures, timelines, and other requirements for the initiation of drug registration testing are formulated and governed by the CDE. The specific working procedures and requirements for drug registration testing before the drug registration application is accepted, as well as the technical requirements and practices for drug registration testing, are formulated and determined by the NIFDC.

The applicant may propose drug registration testing to the NIFDC before the drug registration application is accepted by the CDE (preregistration testing). In cases where the applicant does not propose drug registration testing before this, the drug registration testing will be initiated by the CDE after accepting the drug registration application.

Based on the NIFDC guideline Specification for Procedures and Technical Requirements of Drug Registration Testing, the applicant should conduct sampling as required and send the samples, dossiers required for drug registration testing, reference standards, and special experimental materials and equipment (if needed) to the NIFDC.

The dossiers required for the drug registration testing should be consistent with the corresponding contents of the drug registration application dossiers. In addition, the drug testing institution (e.g., the NIFDC or its associated testing institution) and samples and dossiers submitted by the applicant should not be changed during drug registration testing.

The drug testing institution should, within five working days, review the samples/reference standards and dossiers submitted by the applicant for quality control testing, decide whether or not to accept them, and notify the CDE at the same time. If it is necessary to make corrections, the applicant should be informed by a one-time notification.

After drug registration testing is completed, the drug testing institution should submit the sample testing report and/or specification verification opinions to the NIFDC, which is responsible for collecting and sending these registration testing reports to CDE and/or the applicant.

General Aspects Related To Testing Specifications Required In China

Two of the major challenges around testing specifications are that China requires:

residual DNA and residual Protein A tests for drug substance registration specification
additional Chinese Pharmacopeia tests that are not required in global markets, e.g., abnormal toxicity tests (ATT).

To help address these challenges, we propose that the Chinese authority consider:

More closely aligning the Chinese Pharmacopeia with other major pharmacopoeia to reduce specification divergence and the need for additional testing for China-specific pharmacopeial requirements
Instituting a process to waive certain tests (e.g., residual DNA and residual Protein A) when studies can show clearance of those impurities and remove the requirement for ATT. These are globally accepted testing strategies and performing these tests provides no scientific benefit to assessing the product quality.

These general recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

Drug Registration Testing — Overview of the Current Challenges

Many biological products have long production turnaround times and high manufacturing costs. The stringent requirements regarding Chinese drug registration testing pose significant challenges that could delay the availability of new medications to Chinese patients. Some of the major challenges around testing specifications are that China has:

stringent requirements regarding the number of batches, the source of batches, and the remaining shelf life of batches
stringent dossier requirements for drug registration sample submission
challenging sample submission timelines for the second round of drug registration testing
a lack of guidance on the requirements and scope of sample testing for post-approval CMC supplemental submissions.

Drug Registration Testing — Recommendations

In view of the above challenges, we propose the following changes to align more closely with international and ICH member practices:

When submitting multiple manufacturing sites at registration (to assure that the supply of product to China is met and not disrupted), allow flexibility in the number of batches required from each site, which would facilitate more sites to be registered sooner to meet demand.
Due to limits in the remaining shelf life for commercial-scale batches, allow for less expiry and use reliance to perform a reduced set of registration testing. Also, possibly perform a risk assessment to determine whether testing is required.
The post-approval change guidance should be updated to provide more clarity on which changes would be subject to testing requirements. At present, this is causing almost all submissions to be subject to testing, even when it is not necessary and could potentially delay the implementation of the change and result in Chinese supply challenges. Also, consider reducing registration testing as much as possible based on a risk-based approach.

Each of these challenges can significantly delay the approval process or even cause rejection of the submission due to missed timelines that are difficult to meet. Addressing these challenges through our recommendations can create a smoother review and testing process and accelerate access to product for the population.

Import Product Specifications — Overview of the Current Challenges

China requires the specifications to be aligned with the approved specifications in other major markets (e.g., the U.S., EU, and/or Japan) as well as additional test items required by the Chinese Pharmacopeia. Initial Chinese NDA submissions often adopt the proposed global specifications, which may evolve during the review by other major markets, resulting in tighter approved specifications. These tighter approved specifications in other major markets may contain additional specifications that are not included in the initially proposed global specifications.

During review, if the Chinese agency requests alignment between China’s proposed and U.S./EU/JP approved specifications, especially to add the additional test items to Chinese drug registration specifications, a second round of drug registration testing is often inevitable, which would result in another five to six months of delay in Chinese approval.

We propose the following points for consideration by the Chinese authority to overcome the challenges:

Change the requirement for the most stringent specifications globally to the tightest specifications for countries that receive the product from the same supply chain. This will allow the product to remain the same as it is for other countries receiving the same supply chain’s product.
Reduce additional Chinese-specific testing for commercial batches to align with global testing.

With these recommendations, the product testing requirements can be aligned with those of other major/ICH agencies, therefore reducing the necessity of a second round of testing and, consequently, patients will have faster access to products.

Conclusion

Significant effort has been made by Chinese authorities to harmonize with ICH requirements, speed up review and approval timelines, and promote innovative and simultaneous drug development. However, Chinese regulatory requirements still have unique elements that provide additional complexity compared to other major markets. The additional testing required is considered a tremendous and unnecessary effort for the Chinese industry, as the tests not deemed mandatory to demonstrate product quality. The recommendations outlined above will help solve the challenges, optimize the processes, and strive for harmonization. This will pave the way for simultaneous global submissions in a timely manner so that China’s patients will benefit from lifesaving therapeutics earlier.

This article summarizes some of the main points from a recent BioPhorum publication on this topic. To learn more, check out the full paper, Import product specification and drug registration testing for China.