As there are different regulatory authorities to strictly monitor pharmaceutical companies where compliance, clarity, and accuracy are crucial elements to follow (Kumar, 2023). This demand careful attention from pharmaceutical companies that investigational product (IMP) labels play critical role as these labels contain all the essential information regarding drugs like formulas, ingredients, and standard dosage along with their regulatory touchpoint (Whirl‐Carrillo, 2021). Translation errors cause regulatory penalties, with mislabelling accounting for 10% of the product recalls. Polyglot labelling is crucial, as 40% of drugs are distributed on a global level. Cultural adaptation is equally important, as inadequate translations leads to 15% of medication misunderstandings (World Health Organization [WHO], 2021), see Figure 1. Thus, translating these labels in accurate way is mandatory, especially when these drugs are utilized globally and the readers of this information have different backgrounds and speak different languages. The current article outlines the need for utilizing best practices for translating IMP Labels to ensure quality, compliance, and patient safety by highlighting its importance from various aspects. Moreover, emphasizing the need for an actionable process from decision makers in the pharmaceutical and biotech sectors that demand expertise and an exact approach.
Figure 1: Importance on Investigational Label Translation
As IMP labels contain sensitive information such as dosing instructions, storage requirements, expiration dates, and legal disclaimers which are far more than just text on a package. So, a small mistake in the translation of these labels have terrible consequences (WHO, 2021). Such as, Misinterpreted instructions lead to improper use of the drug which can be a risk for the life of patients. Similarly, inaccurate translation of these labels results in trial delays, fines, or product recalls, and can be the cause of noncompliance with regulatory authorities. Furthermore, a single error in this scenario can be the cause of reputational damage, and trust is a foundation stone in the pharmaceutical industry (Newman-Tancredi, 2022). Leaders of the pharmaceutical companies can better understand the impact of such mistakes and therefore realizing the need for reliable translation partner to maintain the credibility of the firm.
Employing Experienced and Specialized Language Service Providers
Quality always matters, not all services providers provide equal quality of services. For IMP label translation, some key points are necessary to analyze before employing someone to translate IMP labels. As every field has some of its own terminologies, it is, therefore required that pharmaceutical companies must employ linguists with a background in life sciences (Nabavizadeh et al., 2025). The second factor to analyze in this regard is having expertise of linguists in regulatory requirements across the U.S., E.U., and other key markets. Moreover, it is to be considered that linguists must have ISO certifications (e.g., ISO 17100 for translation services and ISO 13485 for medical devices) (Bunt, 2020).
Compliance with Regulatory Requirements
Every country has its own regulatory requirements for IMP labeling, ranging from the use of language its format etc. Such as in EU the requirements are labels must comply with Good Clinical Practice (GCP) guidelines and be translated into all languages of participating countries (Behera et al., 2024). Similarly, the FDA requires labels to meet stringent standards, including clear and concise English for readability in US (WHO, 2021). Thus, understanding these requirements is necessary to ensure that translations are compliant from the beginning of the process.
Ensure Quality Assurance Processes
There must be no compromise on quality assurance process. It should include, Bilingual Review: Every translation should be reviewed by a second linguist with expertise in the target language and the relevant field (WHO, 2024). In-Country Validation: Have the translation validated by native speakers familiar with local regulatory standards (WHO, 2021). Glossary and Style Guide: Maintain consistency by using approved glossaries and style guides for pharmaceutical terminology (WHO, 2024).
Adoption of Technology
In this digital era, with the help of modern technological tools pharmaceutical companies can enhance the accuracy and efficiency of IMP label translation, and for this technological tool can help. Translation Memory: with the help of this strong tool repetition can be reduced and ensures consistency across multiple labels. Terminology Management Tools: provide help in centralized databases by maintaining uniformity in drug names, dosages, and instructions. AI-Assisted Translation: while not a replacement for human expertise, AI speeds up initial drafts, allowing linguists to focus on fine-tuning (Suriyaamporn et al., 2024).
Prioritizing Cultural Expectations
Cultural nuances affect how information is perceived and processed. For instance, colors, symbols, and phrasing that are acceptable in one culture may carry negative associations in another culture. Hence, adapting labels to local cultural expectations is crucial for patient trust and consent (Shahid et al., 2024).
Training and Development
Ensure that all stakeholders involved in the translation process are well-trained. Linguists, must need up-to-date knowledge of regulatory changes therefore required to engage in training programs. Similarly quality assurance specialists, must understand the intricacies of IMP labeling, and project managers, must be engaged in trainings to oversee timelines and ensure seamless communication between teams (Al-Tarawneh, 2024).
Considering the above-mentioned consequences of IMP label translation, it is evident that choosing the right partner can determine the success or failure of your project. When evaluating potential language service providers, a pharmaceutical company must consider some points before employing them. (a) Proven Track Record: Request case studies or references from similar projects. (b) Regulatory Expertise: Ensure familiarity with guidelines like the FDA’s CFR Title 21 and E.U. directives. (c) Scalability: Can the provider handle large volumes across multiple languages? And (d) End-to-End Support: Look for providers who offer services from initial translation to post-approval changes (Ghadanian and Schafheutle, 2024). See Figure 2 for a decisional flow chart of the labelling.
Concluding the above, in pharmaceutical industry accurate IMP label translation have a significant role in ensuring regulatory compliance, and patient safety. Consequently, negligence in any step of this process leads to severe concerns, including legal issues, different kind of penalties from regulatory authorities, and risks regarding patients trust and confidence on the company. But utilizing the best practices such as employing qualified and experienced linguists, incorporating strong quality assurance protocols, and adopting advance technological solutions, the companies of pharmaceutical industries can control and mitigate these risks. Additionally, carefully employing translators with relevant expertise and a proven track record is critical. Thus, prioritizing precision in IMP label translation reinforces the integrity of pharmaceutical companies and contributes to the advancement of global healthcare initiatives.
Figure 2: Decisional Flow Chat for Labelling
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