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Posted 04 May 2015 | By Michael Mezher 

The Biggest Challenge for Regulators That No One's Talking About: Translation


Regulators have long been concerned with the safety, efficacy and quality of the products they regulate. Now they have a new concern to think about: language. South Korea's healthcare products regulator is learning that lesson this week after being called out by The Korea Times for failing to keep its English-language website up to date. But as a review by Regulatory Focus shows, it's hardly the only regulator struggling to translate its documents in a timely manner.

Website Problems

In a report, the paper discovered that the English-language website of the Ministry of Food and Drug Safety (MFDS) still featured its former minister nearly a month after Kim Seung-hee took over as minister.

MFDS has since partially corrected the issue, placing a photograph of Seung-hee, the agency's first female minister, on its "Minister's Message" page. Other parts of the website, including the minister's biography, still mention the former minister, Chung Seung.

The issue, The Korea Times says, is failing to keep the country's English-language website up to date creates misinformation for its many foreign visitors who visit the page looking for "information about Korea's food and drug-related policies and regulations." According to The Korea Times, there is clear interest in English-language information, pointing to a 2013 post on a revision to the country's Medical Devices Act which drew more than 23,000 visitors.

The Language Barrier Online

When looking at the two websites side-by-side, it is clear that the English-language page is chronologically far behind the official Korean language site. The most recent news item on the English-language site is nearly a year old; whereas as of this writing, the Korean-language site features numerous updates from today's date.

The issues cited by The Korea Times are hardly unique to South Korea.

Maintaining second-language websites is a challenge for regulators around the world, as it takes a great deal of time and resources to maintain a website. For regulators operating in resource-poor countries, an agency may lack the staff, expertise or time to translate its

essential regulatory documents or announcements. It is also clearly more important to a national regulator's mission to provide information in its country's official language.

Even well-funded regulators such as the US Food and Drug Administration (FDA), whose Spanish-language website features "Spanish versions of important FDA publications," face routine difficulties translating important documents into other languages. A quick scan of its Articulos en Espanol shows fewer recent articles than the English-language consumer update page, indicating not all documents are translated.

Even the European Medicines Agency (EMA), an agency which routinely operates in more than a dozen languages, does not translate all of its documents from English, and the agency's website is only available in English. Specific types of documents are translated into all official EU languages, such as European public assessment reports (EPARs) and recruitment information, but other documents such as press releases may be posted in English only.

Many recognize the ongoing challenge of accessing regulatory information in second languages. Accessing information in other common languages is important not only for travelers or people who do not speak a country's official language, but for international regulatory professionals who may be looking for information directly from the regulator, rather than relying on translation services.

The Broader Issue

The work of regulatory professionals is increasingly global in scope, and effective communication is critical for both regulators and the regulated industry. Companies market their products around the world, and regulators often travel to foreign manufacturers to conduct inspections.

In these cases, a language barrier can be a major challenge. The extent of this challenge is evidenced in a recent Economic Times article Lost in translation: US FDA inspectors, Indian drugmakers face language gap. The article discusses the language barrier between FDA inspectors visiting Indian drug manufacturers. What is striking in Economic Times piece is that all parties in the article spoke and understood English, but had difficulties understanding the other party's accent.

The Korea Times


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