The United States, India, and Switzerland: three countries with industries strategically linked in a manner that allows for a cohesive global supply chain. A single medicine can be created and packaged multiple times around the world, allowing for a very fast-paced industry. However, from a human standpoint, this poses an issue where communication—through language, culture, and dialects—needs to be straightforward and easy. A drug’s label, along with the insert, is treated more as a legal description than as paperwork in a cardboard box. More often than not, it’s the last chance to protect a patient from an incorrectly administered procedure and harm. For people with chronic sicknesses, any instructions dealing with caution, warning, and dosing aren't optional; they're mandatory. While in transit from one country to another, numerous translations are made that miss the mark on preserving the essence of the original words, feel, or intention. That's where the process of localization will come in handy (Huang et al., 2024).
When folks think about making a drug label "multilingual," they often think it's just about translating the words. But it's more complex than that. It has an impact on adapting the message to suit the language, regulatory, and cultural context of the end user.
Localization involves
● Translating text — to keep the meaning intact.
● adapting to culture — to ensure people don't misunderstand phrases, symbols, and even colors.
● Following regulations — to make sure the product meets local legal and medical rules.
● Tweaking the design so the text fits well within the packaging without crowding or warping.
The risks are enormous because pharmaceutical localization isn't about marketing — it's about communicating information that could mean life or death (Chashnikova, 2024).
Figure 1: Process of localization (Chashnikova, 2024)
Drug makers face a major challenge: each country has unique rules for presenting drug information.
Some examples:
● In the US, the FDA demands detailed instructions and prominent black-box warnings for high-risk drugs.
● In Europe, the EMA focuses on reporting side effects and packaging in all EU languages.
● Health Canada requires drug labels in both English and French, with word-for-word translations.
Picture a global pharma company launching a product in over 30 markets. Each market has its own rules about
● The smallest and largest font sizes allowed.
● Warnings that must be included.
● How to list side effects.
● Drug codes and serial numbers to use.
If just one small detail is missed, the product might never hit the shelves, get pulled after launch, or lead to lawsuits.
Tone of voice serves as a good example. In America, people usually like clear and straight instructions. But in other countries, this can seem rude or upsetting. For example, in Japan, being polite and creating harmony are important, so people often use softer and less direct language for warnings.
Symbolism and visuals also vary across cultures. For example:
- The color red is seen as "danger" in Western cultures but means good luck in China.
- An icon or diagram that makes sense in New York could confuse or upset people in the Middle East or Africa.
Measurement systems can be challenging too. Medicine dosages might be given in milligrams (mg) in one place but need to be in international units (IU) elsewhere. Making errors in this change can cause dangerous overdoses or not enough medicine (Girolami, 2024).
Every medicine package, no matter the size, has a limited area for text. A label in just one language might fit well. However, when you include five, ten, or even fifteen translations, it can become quite challenging to arrange it all clearly.
Languages can change the length of the same sentence
- English: “Take one tablet daily after meals.”
- German: “Nehmen Sie einmal täglich eine Tablette nach den Mahlzeiten ein.”
- Chinese: “每日餐后服用一片。”
These sentences can differ in word count, line breaks, and character size. Designers must deal with these challenges while ensuring the text remains:
- Legibility
- Regulatory required elements.
- Hierarchical clarity (headlines, subheadings, body text).
Every layout revision is subject to approval by both legal and regulatory teams, adding time and complexity to the localization process.
Companies nowadays seek cost savings and time efficiency through the implementation of machine translation. Google Translate, along with DeepL, implements better capabilities for understanding spoken languages. The pharmaceutical industry faces severe problems from any translation mistake, no matter how minor it may be.
Machines often face challenges with:
● The word "discharge," along with other ambiguous terms, produces multiple possible interpretations. The word can refer either to patient release from hospital care or to bodily fluid elimination. The context determines the meaning.
● The formal legal language used in regulations remains a point where machines show limited ability to interpret its required precise terminology.
● A person instantly detects subtle cultural differences that remain hidden from machine interpretation systems.
● The most advanced translation technologies need human translators to perform their work because of multiple factors. Medical translators with appropriate experience ensure both accuracy and safety and understandability for patient information.
A real-life pharmaceutical company case investigates the imperative role of accuracy during translations
Let’s revisit the “once” vs. “once” problem — a textbook example in the translation world.
The pharmaceutical company decided to release English-speaking drug labels in Germany while neglecting proper localization services. German users understood the English word “once” as the German word elf, which signifies the number eleven. The result? A single erroneous word led patients to experience an 11-fold accidental overdose. This isn’t an isolated case. Several similar localization mistakes throughout the years have produced wrong output that ultimately led to
• Incorrect dosage instructions.
• Confusing contraindication lists.
• Vague or incomplete allergy warnings.
The errors present a fatal risk to patients. The moral? Localizing information stands as much more than bureaucratic processes since it ensures direct patient security (Shaitarova et al., 2023).
● Localization isn’t a solo mission. It’s a team effort involving
● Specialists in regulatory affairs function to translate legal aspects required for patient-centered services.
● Both medical writers and specialist regulatory workers handle the initial content creation.
● Professional translators contribute by making the content local to specific regions.
● Cultural consultants who ensure appropriateness.
● The quality assurance teams function as final inspectors of all finished materials.
● Multiple specialized teams working together establish control systems to find mistakes between initial creation and patient delivery. Multiple review stages create necessary protections because errors inevitably occur when these stages are missing (Girolami, 2024).
Figure 2: Fail case of training process of LLMs caused by Multilingualism (Huang et al., 2024)
Patients experience the end of the supply chain when they need medical attention at any time, day or night, irrespective of their age, including healthcare providers under demanding situations. The accuracy of labels directly corresponds to the ease of work performance for those at the patient stage. Misidentified products create delays while often leading to patient-related accidents between the time of delivery and treatment. Making deliveries correctly surpasses basic business requirements because doing so represents a basic ethical responsibility (Shaitarova et al., 2023).
The practice of pharmaceutical localization brings significant personal value to patient safety despite its hidden behind-the-scenes nature. Pharmaceutical labels must provide protection instead of basic information, whether manufacturers label pills or essential injectables. Manufacturers who localize products accomplish much more than following guidelines or entering different markets. You need to respect patient trust regardless of their spoken language while sharing information about your product. Words persistently matter since every breakthrough in medical technology extends from their essential role.
Chashnikova, E. (2024). Localisation of promotional materials for pharma. Medical Writing, 33(1), 58–61. https://doi.org/10.56012/ajhl9537
Girolami, D. (2024). Linguistic and Cultural Mediation in Healthcare Settings - The case of “La Marca Trevigiana”: Considerations, challenges and new paradigms for interpreter-mediated encounters. https://unitesi.unive.it/handle/20.500.14247/12726
Huang, K., Mo, F., Zhang, X., Li, H., Li, Y., Zhang, Y., Yi, W., Mao, Y., Liu, J., Xu, Y., Xu, J., Nie, J.-Y., & Liu, Y. (2024). A survey on large language models with multilingualism: Recent advances and new frontiers. arXiv. https://doi.org/10.48550/ARXIV.2405.10936
Shaitarova, A., Zaghir, J., Lavelli, A., Krauthammer, M., & Rinaldi, F. (2023). Exploring the latest highlights in medical natural language processing across multiple languages: A survey. Yearbook of Medical Informatics, 32(01), 230–243. https://doi.org/10.1055/s-0043-1768726
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