Translation of Drug Registration Documentation

What is special about pharmaceutical translations?

Below we describe our view of pharmaceutical translations. Here you can find out about special requirements and see how we can help you to translate your documents.

Language requirements

During all phases of a pharmaceutical product's life cycle, from manufacturing to marketing, our clients must meet the requirements of the various regulations issued by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), Japan's Ministry of Health, Labor and Welfare (MHLW), as well as the Ministry of Health of the Ukraine (in relation to the Ukrainian market). To sell in these markets, companies should comply with the language requirements of the countries to which they export, and should provide documentation in up to 14 languages.

Labeling requlations

In addition to general regulations, there are a number of labeling regulations, which differ from country to country. Labeling regulations for Russia and the Ukraine largely follow international guidelines. In 1998, the Russian Federation passed the Federal Drug Law. This includes labeling requirements, and, for the most part, complies with international standards. IMP labels must be translated into Russian and Ukrainian.

In the Ukraine, the Order of the Ministry of Health of the Ukraine dated 26.08.2005 No. 426 "Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products, which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Documents during the Validity Period of Registration Certificate" as amended by Orders No. 95 dated 01.03.2006 and No. 536 dated 11.09.2007 governs drug registration procedure and sets labeling language requirements for imported medicinal products.

Adaptation needs

We are also aware of the adaptations required to create socially, linguistically and culturally sensitive translations. This is particularly important in translating patient-oriented documents as opposed to doctor-oriented ones.

Types of documents we translate for pharmaceutical companies

• Drug Information (labels, inserts, packaging etc.)
• Regulatory Submissions
• Drug Registration Dossiers
• Medical Journals and Publications
• Pharmacological Studies
• Standard Operating Procedures (SOP)
• Marketing, Promotional and Consumer Education Materials etc.