Customer Name: Nuxe
Customer Sector: Cosmetics
Within the scope of the current project, an excerpt from an EMA (European Medicines Agency) guideline on similar biological medicinal products was translated from English into Turkish.
CHALLENGES
- Due to the comprehensive and complicated nature of the source text, applicable regulations and guidelines on cosmetic products are required to be reviewed to ensure that accurate information is provided for the application process defined in the relevant guideline.
- The source text was somehow written in a complex manner, often containing several subordinate clauses in one full sentence. In some cases, the subject of a sentence may be unclear in the target text if it is not formulated in a carefully structured way.
- A similar guideline published by Turkish Medicines and Medical Devices Agency exists on similar biological medicinal products, also called biosimilars. From a regulatory point of view, some terms and elements of the application process are different from each other.
- The company’s own internal dynamics prevented us from using certain phrasing in the target text since such phrasing is interpreted by the company in a different way than it was suggested in the source text; therefore, a different approach must be adopted to find a more suitable phrasing in this sense.
SOLUTIONS
- Complexity issue of the source text must be resolved in the target text by providing a simplified version for the target reader. This issue was addressed by keeping in close contact with the client and upon receiving additional feedback from the company on the initial translation draft, we made the necessary changes in the final draft to ensure consistency in the target text in line with the requirements.
- Subordinate clauses were reformulated and translated in a more comprehensible manner to avoid confusion of the subject of a clause. In one sentence, for instance, whether the extrapolation of indications was intended for the reference product or the biosimilar was unclear and must therefore be clarified before submission of the final draft. By contacting the client, this issue was resolved and the resulting translation turned out to be more satisfactory for the client.
- Since this was a regulatory document, a comparison between the guidelines published by EMA and Turkish Medicines and Medical Devices Agency was made to check medical terminology used to ensure consistency.
SOLUTION ELEMENTS
- Competence and experience in the field of medical translation and translation of regulatory documents.
- Comprehensive knowledge of both national and international guidelines and regulations on pharmaceuticals and clinical trials.
- Keeping in communication with the client and ensuring collaboration.
BENEFITS
- Providing the client with a local version of a crucial guideline to be used in regulatory procedures.
- Ensuring there is no ambiguity about the application process so that no mistake is made during such application which could otherwise slow down the application process.
