HARMONIZATION AND COMPLIANCE IN ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) SUBMISSIONS AND LABEL TRANSLATIONS

1. Background

Accuracy of the meaning and perfection in terminology selection are the integral parts of translation process. Translation of product labeling in pharma industry is not just for the sake of fulfilling the operational requirements. It plays a significant role in safety measures regarding use the of different sensitive products related to medical industry. Therefore, international legislative authorities that deal with document submission demand translation in multiple languages. When it comes to eCTD submission, it is mandatory whether it is a drug label, summaries of product characteristics, or patient booklets, it should be translated into multiple languages (Klick, 2025). Because a minor mistake in the use of terminologies can lead to severe consequences, including risks to patients’ health, eCTD rejections, and expensive delays in launch of the products. Thus, the convergence of eCTD and label translation stresses on the need for pharma companies to adopt some exclusive strategies that ensure accuracy of language, legislative compliance, and submission efficiency. In addition to this, understanding the role of eCTD in document submission and legislative compliance, companies must need to recognize the related challenges and to adopt smart practices for efficient handling of these challenging issues (Sudesamithiran, 2023).

2. eCTD: A Globally Accepted Format

The eCTD is the globally accepted format for electronic regulatory submissions for pharmaceutical products (Ajmal et al., 2025). It is basically a comprehensive approach that provides a detailed, standardized, and structured format for submitting data to different legislative authorities, like Food and Drug Administration (FDA) in United States, and the European Medicines Agency (EMA). The eCTD structure is basically based on five core modules. First one is related to regional administrative information. The second one related to summaries of clinical and non-clinical data. Third module deals with Chemistry and Manufacturing information. Similarly. Fourth one is related to non-clinical study reports, and fifth one is based on clinical study reports.But among all five, Module 1 is of particular significance for label translation, as it includes the labeling requirements of different legislative authorities. So, failure in meeting the requirements of first module may possibly delay approvals of eCTD submissions, requires resubmissions, and disturb timely market entry plans (Rupnawar and Wani, 2024). Figure 1 illustrates the eCTD development and approval process.

3. Label Translation: A Critical Factor

Drug labeling is not just an informative document, it is a legally necessary representation of a drug’s intended use, safety profile, and regulatory compliance (Krishna et al., 2023). Legislative authorities enforce strict linguistic and formatting standards to ensure that translated labels align with the original approved documentation and maintain consistency across all versions (Khristi and Gupta, 2024). Moreover, legislative authorities in different regions have specific requirements regarding the languages and formats in which labeling documents must be submitted. The FDA mandates English labeling but requires Spanish translations for bilingual markets such as Puerto Rico. Likewise, the EMA requires pharmaceutical labels to be translated into all 24 official EU languages, with a stringent review process to ensure accuracy (Arciero, 2021). Furthermore, China’s legislative authorities demand precise medical terminology in simplified Chinese. These regulations demand an exclusive approach for translation, because even minor mistake or error in medical terminology, dosage instructions, or safety warnings can result in approval delays and increased compliance costs (Patil et al., 2024). Figure 2 illustrates key translation workflow stages.

4. Challenges in Label Translation

1. Translating medical terminology requires expertise to ensure perfection. A mistranslation of a dosage instruction or contraindication can result in severe safety risks. Consequently, perfection in terminology across all languages must be required to prevent misinterpretation by doctors, pharmacists and patients (Khristi and Gupta, 2024).
2. Legislative authorities demand uniformity in labeling content across different languages. Any discrepancies between translated versions can lead to time consuming revisions and resubmissions (Makwana et al., 2021).
3. Frequent updates and version control labeling protocols are frequently evolving based on new safety standards and updated scientific guiding principles. In this scenario, managing multiple language versions while ensuring compliance with the latest governing changes adds another layer of complexity to eCTD submissions (Janjal et al., 2021).
4. Formatting and technical compliance in labeling documents failure to meet technical specifications can result in validation failures, requiring corrections and resubmissions (Huma and Peng, 2023).

5. Smart Practices to Overcome Challenges

Pharma companies must develop exclusive strategies to efficiently handle the given challenges.

1. Engagement of Qualified Medical Translators: Partnering with local professional medical translators from that particular region who have expertise related to legislative matters would be beneficial. Moreover, compliance with ISO 17100, which is related to translation standard, further guarantees translation quality and reliability (Popio?ek, 2023).
2. Implement Quality Assurance Process: A quality assurance process provides help in verification of the accuracy of translated content. Computer software can be integrated to maintain consistency across multiple documents, reducing the probability of errors (Badjatya et al., 2022).
3. Utilization of Artificial Intelligence (AI) Tools: AI based translation tools simplify translations by storing and reusing previously validated translations. This approach ensures perfection and consistency with labeling updates and minimizes the time required for again and again translation when regulatory updates take place (El Naqa et al., 2023).
4. Ensure Compliance with eCTD Submission Standards: For ensuring compliance, utilization of the structured product labeling format, and adopting quality review of documents should be necessary (Patil et al., 2024).
5. Ongoing Monitoring: Continuous monitoring of international regulatory changes, combined with proactive pharmacovigilance efforts, ensures that translated labels remain compliant with evolving safety requirements and market regulations (Khristi and Gupta, 2024).

6. Delay in Obtaining EMA Approval: A Case Study

In 2023, a leading pharma company faced a delay of three months in obtaining EMA approval because of a difference in translation belonging to the product’s label submitted in multiple EU languages. After the submission review, they identified discrepancies in dosage that did not align with the original English label. As a result, the company conducted a complete linguistic re-evaluation, incurring significant additional costs and delaying market entry. Consequently, this case highlights the importance of careful translation of all the material and regulatory arrangements from the start to avoid any expensive mistake.

7. Conclusion

An accurate and exact language translation of the documents and materials considered to be the key aspect of eCTD submissions, compliance with regulatory requirements, and patients’ safety. Thus, it is necessary for every reputed pharma company to adopt a proactive, innovation-driven, and quality focused approach for the purpose of translation and submission management. In fact, involving expert medical translators, AI-assisted translation tools, and strict quality assurance processes, organizations can improve the efficiency of their eCTD submissions while ensuring compliance with international regulatory requirements. Moreover, the ability to efficiently handle these kinds of challenges not only reduces risks of eCTD rejections but also improve the chances of being a market leader by fast market entry, and spreading lifesaving drugs globally without unnecessary delays.

References

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