In an effort to improve the timeliness and consistency of product information changes, the European Medicines Agency (EMA) is now translating recommendations in all official EU languages, plus Icelandic and Norwegian. Background In the EU, pharmaceutical companies are required to provide translations of product information to EMA after a product is authorized. The translations must be made in all official EU languages, including Icelandic and Norwegian. From time to ...

If you're reading this article, chances are good you take something for granted every day: your ability to read. But even beyond that, the fact that you're reading Regulatory Focus means you're probably fluent in English and well-versed in medical terminology. Many Americans, though, can't read, can't read or speak English, or can't read or speak English well enough to understand the medical terminology that is necessary to interpret the labels on medical products like...

The European Medicines Agency (EMA) has two messages for applicants of marketing authorization applications: please submit all applications electronically, and don't forget to submit labeling translations to Croatian regulatory authorities. In a statement released 5 July, EMA said it is imploring sponsors of pharmaceutical products to start taking advantage of its electronic application forms, including its eSubmission Gateway, due to its relative ease of use. The ag...

The US Food and Drug Administration's (FDA) Associate Commissioner for International Programs, Mary Lou Valdez, said in a statement the agency is working to translate many publications into different languages in order to help its foreign regulatory counterparts. In FDA's 11 April statement, Valdez notes the Office of International Programs (OIP) is "committed to supporting the agency's efforts to become a regulatory agency with a truly global reach." As a result, OIP i...