Drug regulatory agencies (DRAs) have adopted regulatory science (RS) to improve the scientific justification for benefit/risk analysis and regulatory decisions based on the best available knowledge. As a regulatory framework, RS is given top importance by the National Medical Products Administration (NMPA) in China. The NMPA introduced the Action Plan of Regulatory Science in May 2019, which is the first formal initiative that follows the global trend of RS development. The plan of action demonstrates the agency's commitment to developing new tools, standards, and techniques to address current and future difficulties. China's National Medical Products Association (NMPA) should lay out the principles and guidelines of its regulatory decision-making to ensure consistency with regulatory standards (Liang et al., 2021).
Accurate translation of medical content is critical for bridging communication and linguistic barriers across diverse audiences. In the globally interconnected world today, translating scientific and medical content is essential as well—to provide information to non-native language speakers When you are focused on trial data, clinical results, and regulatory strategy, your submission documentation may quietly be falling short in the first checkpoint: accurate, culturally-appropriate, and legislative-ready translation. And your entire product launch could be disrupted by this one mistake.
Let us examine how and why inadequate translation ruins NMPA submissions, as well as what leaders in APAC and pharmaceutical experts in the US should know to prevent it from happening.
Figure 1. Key government bodies within the Chinese healthcare sector (Kanavos et al., 2019)
The NMPA in China does more than simply examine your data. It examines the presentation, formatting, interpretation, and localization of that data. Clinical protocols, informed consent forms (ICFs), labeling, and package inserts are examples of submission papers that must not only have the correct wording but also the correct intent, regulatory structure, and linguistic accuracy. Along with regulatory writing, scientific publishing, health communication, professional development, funding applications, and promotional writing, medical translation is an important part of worldwide medical communication. The NMPA may require risk management plans (RMPs), which outline techniques and protocols to identify and minimize the risks associated, to be submitted as part of the registration process for specific drugs. The NMPA conducts post-marketing surveillance to monitor the safety and effectiveness of presently marketed pharmaceuticals through regular audits, inspections, and evaluation of safety data. To ascertain whether copyrighted regulatory steps, like labeling revisions or limitations, are necessary, the NMPA uses a variety of techniques for signal recognition and evaluation, carefully evaluating the possible safety signals from ADR reports and other data sources. The NMPA has the power to ask pharmaceutical companies to update drug labels with new safety information, and it issues safety communications to the public and healthcare professionals (Ali & Nollet, 2024).
Creating a translational medicine platform (TMP) is a smart way to close the gap between fundamental research and clinical use. The TMP's main goal is to build strong relationships between physicians, public health professionals, and basic medical researchers, especially in order to successfully approve the product by NMPA and helps in appropriate disease prevention, diagnosis, treatment (Fischbach, 1962).
We must remember that, in translation, a copy that signifies one thing in English might readily indicate another in the target language. This intentional implication could turn out to be illogical, demeaning, or even indecent. The fact that some scientific terms may appear to be completely acceptable related terms but, when used as such, produce a mistranslation is another challenge.
The French term for peptic ulcer is "ulcere gastro-duodenal," not "ulcere peptique," and the English term for anthrax is "carbuncle."
The word "Halsweh" also means "pain in the neck" in German, but a German doctor interprets it as "sore throat."
One major point of concern is informed consent forms, or ICFs. A form that conforms to U.S. IRB criteria may not meet Chinese requirements for compensation provisions, legal guardianship, or patient autonomy. If not appropriately localized, even a phrase like "you may withdraw at any time" can have distinct legal connotations in China.
One of your submission's most visible steps to the public is labeling. Due to automatic translation, a large U.S. pharmaceutical company experienced a 6-month delay in 2024 when their Chinese medicine label featured mismatched dose units. The outcome? Before launch, the NMPA must fully relabel and reapprove.
NMPA employs specialized Chinese regulation terminology. Even if your translation is medically accurate, reviewers will be suspicious if it does not match those terms. Back-and-forth inquiries, resubmissions, and possible rejection result from this.
Figure 2. Detailed Translation Process for Hong Kong Research Institutions' NMPA Submissions (Lu et al., 2025)
Not all translators are the same. When dealing with NMPA, using general translators might end up causing harm rather than helping. What you really need is a medical translation expert, ideally one who knows the regulations in China and the wider APAC area. Here’s why:
● Being fluent in the language isn’t enough. Your translator must know ICH-GCP, China GCP, and NMPA-specific rules.
● The fine details in medicine are key. Translators must spot the differences between the purpose of a therapy and its clinical mechanism in the body.
● How you format your documents counts. Even the layout or the making of tables changes how NMPA sees them.
The best plan? Team up with people who know about regulatory matters, medical writing, and the Chinese language, all of whom are trained in life sciences. That should be the top choice.
Poor medical translation isn’t just a clerical error—it’s a leading cause of regulatory rejections in Asia-Pacific markets, particularly by authorities like China’s NMPA, Japan’s PMDA, and Korea’s KFDA. Generic translation services fall short when navigating the region’s complex compliance demands. That’s why at Willingjet Life Sciences, we don’t just translate—we deliver multilingual regulatory submission packages designed for precision, compliance, and speed. From Labeling Compliance Review & Translation for APAC to China Market Access Enablement, we support global life science companies with cross-border consulting, local submission coordination, and full linguistic validation. Our ISO-certified experts ensure your clinical, labeling, and technical documentation aligns with evolving regional regulations—because in global health, accuracy isn’t optional, it’s essential.
The translation process encountered various challenges, varying from minor technical issues to disparities in social norms. US and APAC pharmaceutical leaders can keep ahead by following such practical measures.
1. Begin Translating As Soon As Possible
Translation should not be viewed as the last step.From the beginning, incorporate it into your submission roadmap. This allows translators time to properly localize and align your scientific narrative.
2. Employ A Translation Team Under Regulatory Guidance
Select partners who collaborate closely with regulatory advisors, particularly those who have expertise submitting to the NMPA.
3. Do Not Just Translate; Localize
Consider more than just words. Adhere to local ethical, legal, and cultural conventions while creating your ICFs, product labels, and patient education materials.
4. Conduct Linguistic Verification
Particularly for patient-facing materials (such as PROs or ICFs), perform validation studies, cognitive debriefing, and back-translations to satisfy NMPA requirements (Menon & Venkateswaran, 2017).
5. Establish A Glossary Exclusive To China
At the beginning of your project, create a terminology foundation using NMPA-preferred terms. This makes sections and lifecycle documents more consistent.
Over the last five years, China's NMPA has gone through tremendous maturation. Long grace periods and "special treatment" for international submissions are things of the past.
● Maintains the same high requirements for international businesses as for domestic ones
● Rejects applications that are inconsistent or incomplete outright and mandates that clinical trial designs, including ICFs and patient materials, be localized.
● Translation is now more than just translating from English to Mandarin. It involves transforming your global strategy into a story that is acceptable in China and compelling to Chinese officials, patients, and medical professionals.
Despite advancements, AI systems such as ChatGPT and DeepL continue to overlook important context and legal aspects.Use them cautiously and always rely on expert human translators for NMPA submissions.
The Chinese market is too large and too competitive to waste your opportunity with a poor submission. Translation that is precise, strategic, and of regulatory quality is essential if you want to compete in APAC, particularly in China. Inadequate translation is a regulatory obstacle that can delay or even ruin your NMPA submission, making it more than just a language mistake. Since China's NMPA places a strong emphasis on localization, precision, and regulatory science, clearance depends on precise translation. Poor translation, inaccurate labeling, or ethical conflict could result in costly delays or rejections.. For submissions with such large stakes, AI techniques by themselves are still unreliable. To avoid setbacks, your plan must include translation from the beginning, supervised by experts who are knowledgeable about the language and the rules. Your documents will effectively and accurately meet China's regulatory requirements if you use specialized medical translators.
Ali, F., & Nollet, L. M. L. (Eds.). (2024). Global regulations of medicinal, pharmaceutical, and food products. CRC Press. https://doi.org/10.1201/9781003296492
Fischbach, H. (1962). Problems of medical translation. Bulletin of the Medical Library Association, 50(3), 462–472.
Kanavos, P., Mills, M., & Zhang, A. (2019). Pharmaceutical policy in China. LSE Consulting. https://doi.org/10.21953/LSE.FG2T522B8R1X
Liang, Z., Lai, Y., Li, M., Shi, J., Lei, C. I., Hu, H., & Ung, C. O. L. (2021). Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: A scoping review and regulatory implications. Chinese Medicine, 16(1), 23. https://doi.org/10.1186/s13020-021-00433-2
Lu, Q., Hsueh, Y.-S., Tong, W., Zhang, Y., Xu, J., & Qin, L. (2025). Importance to understand medical device regulations for accelerating clinical translation. Journal of Orthopaedic Translation, 51, 290–297. https://doi.org/10.1016/j.jot.2025.02.002
Menon, D., & Venkateswaran, C. (2017). The process of translation and linguistic validation of the Functional Assessment of Cancer Therapy-Brain quality of life instrument from English to Malayalam: The challenges faced. Indian Journal of Palliative Care, 23(3), 300. https://doi.org/10.4103/IJPC.IJPC_36_17
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