This week I want to delve into the unique challenges of translations in the pharmaceutical industry. As with all medical translations, the biggest challenges often come from the difficult nature of industry specific terminology. The pharmaceutical industry continues to become more globalized as it strives towards unification of its translation processes. As a result, your requirements for high-quality translations is more important than ever. Therefore leveraging translation service providers who are knowledgeable in various stages of regulatory approvals is crucial.
For translations of such a specific industry, within a highly-regulated market, it is imperative that you choose a translation provider that can guarantee subject matter expertise. You should be confident that your translators have the pharmaceutical industry experience to adequately translate for a various intended users. This experience combined with relevant research skills, and professional resources help ensure that your translators are aware of potential difficulties.
When we look at pharmaceutical translations we see a number of different target audiences for items such as:
- Patent documents
- Information for use
For example, Summaries of Product Characteristics (SPCs) and Product Information Leaflets (PILs)/ Package Insert will have drastically different end users, all around the world. A summary of Product Characteristics is required as a part of authorization within the EU, and provides information for health providers. This document details how professionals should use a certain product for treatment. On the other and, Product information leaflets, similar to Package Inserts/prescribing information required by the FDA in the United States, give product users information about conditions, dosages, side effects, etc.
Furthermore, these changes in users will affect how specific terminology is presented. While the proper medical terminology will be present in the SPC, it may be necessary to have a simplified version and description throughout the PIL. Special care must be taken to deal with synonyms, euphemisms, and metaphors so that your information is conveyed with localized readability while maintaining the precise translations.
Globally, countries have their own regulatory bodies which must have information translated from the source language where you develop your product. We are also seeing a shift towards having online access to both professional and patient use information. This creates its own challenges in translation as the industry continues to evolve, to ensure consistency in terminology and content. From research and development to market, the cost of pharmaceutical production can reach millions or even billions. You should be confident that your language service provider thoroughly understands the subject matter at hand. Additionally, the industry specific challenges needs to be addressed to ensure that the entire process runs as smoothly as possible. The pharmaceutical industry is continually evolving while the desire for global access to various treatments is expanding.
To learn how CSOFT can help you with your Pharmaceutical translations, visit our site at www.csoftintl.com