Breaking Down the Critical Role of Pharmaceutical Translation

  • AUTHOR Jennie
  • PUBLISHED ON: 11월 14, 2023
  • PUBLISHED IN: Translation

Pharmaceutical Translation is a critical aspect of the pharmaceutical industry, with significant implications for patient safety, regulatory compliance, and market access. In recent years, the demand for pharmaceutical translation services has increased significantly, reflecting the growing global nature of the pharmaceutical market and the need for accurate and efficient translation of regulatory documents and other critical materials.


According to a report by Grand View Research, the global pharmaceutical contract research and manufacturing market size is expected to reach USD 258.3 billion by 2028, growing at a CAGR of 7.9% from 2023 to 2028 (https: // PressReleases/pharmaceutical-contract-manufacturing.asp). This growth is driven by a range of factors, including increasing demand for outsourcing services, a growing emphasis on drug development and commercialization, and the need for cost-effective solutions. 


Pharmaceutical translation plays a critical role in enabling companies to access new markets and comply with regulatory requirements. In Europe, for example, pharmaceutical companies must submit marketing authorization applications in the official languages ​​​​of each country where they wish to market their products. This means that pharmaceutical companies must translate their marketing authorization applications, clinical trial documents, product labeling, and other materials into multiple languages ​​to comply with regulatory requirements and ensure patient safety.



Inaccurate or incomplete translations can have serious consequences for pharmaceutical companies, including regulatory non-compliance, product recalls, and damage to their reputation. 

1. Regulatory Non-Compliance: The pharmaceutical industry is subject to strict regulatory requirements, and inaccurate or incomplete translations can lead to non-compliance with these requirements. This can result in fines, legal action, or the inability to market products in certain countries.

​2. Product Recalls: If a product label or package insert is inaccurately translated, it can lead to medication errors or adverse reactions, which may result in product recalls. Product recalls can be costly for pharmaceutical companies, both in terms of financial losses and damage to their reputation. A study by the US Food and Drug Administration (FDA) found that one of the top drug recall causes was incorrect labeling, highlighting the importance of accurate and efficient translation of product labeling and packaging materials.

​3. Damage to Reputation: Inaccurate or incomplete translations can damage a pharmaceutical company's reputation. Patients and healthcare providers rely on accurate and understandable information to make informed decisions about medications and treatments. If the information is inaccurate or incomplete, it can erode trust in the company and its products.


4. Negative Impact on Patient Health: Inaccurate translations can have a negative impact on patient health. Patients who do not understand the instructions for their medication or the potential risks and benefits of a particular treatment may not take their medication correctly or may experience adverse reactions. This can lead to poor health outcomes and may even be life-threatening.

​5. Legal Liability: Inaccurate translations can also result in legal liability for pharmaceutical companies. If a patient is harmed as a result of an inaccurate translation, the company may be held legally responsible.

In conclusion, pharmaceutical translation is a critical aspect of the pharmaceutical industry that plays a key role in enabling companies to access new markets, comply with regulatory requirements, and ensure patient safety. As the global pharmaceutical market continues to grow, the demand for accurate and efficient pharmaceutical translation services will only continue to increase. Pharmaceutical translation requires a great deal of knowledge and attention to detail. Even the slightest mistake in pharmaceutical translation can have serious consequences.


At MOBICO by Saltlux Innovation ​, we understand the critical role that pharmaceutical translation plays in ensuring patient safety and regulatory compliance. Our team of expert translators has extensive experience in translating a wide range of pharmaceutical documents, including clinical trial protocols, regulatory submissions, product labeling, and packaging. We use advanced translation technology and rigorous quality control processes to ensure that our translations are accurate and consistent across all languages ​​​​and regions, enabling our clients to access new markets and comply with regulatory requirements with confidence. Contact us today to learn more about our pharmaceutical translation services.