Translation of documents, particularly medical documents, is not something most people in the US think about as we only have one official language and almost all work is done in English. Similarly in drug safety and pharmacovigilance this is not a major concern in the US. However, outside the US, where there are countries with more than one official language (e.g. Canada, Belgium), this can be a major issue.

This is the case in the European Union/European Economic Area where there are over two dozen languages used. The EU has over 5000 translators and interpreters on staff. In 2016 the EU translated three quarters of a million pages. T he average cost is 82 euros per page translated. In 2008 the EU spent about 1.1 billion euros on language services. About 1/3 of the work appears to be outsourced. It is difficult to find the current costs of language services as they are fragmented and the costs buried.

Companies handle language issues in many ways. Some documents do not have to be translated or sent anywhere but many other documents must go to multiple countries in multiple languages. Most companies and some national governments use English as the language of pharmaceutical communications but many end up using two or more languages in daily work: the national language(s) and English. This topic is way too big to deal with here so we will focus only on language and translation issues in PV.

Translation Issues in PV

Clearly there are needs in PV when data, cases, case reports, hospital records, regulatory communications and other documents are received in languages other than English (which is the de facto global language of PV). Many countries and companies require that all documents be submitted in English (e.g. Expedited Reports and PSURs in most countries).

In PV, the usual model is to have the local safety officer or CRO translate anything that must be sent in English. This may put the burden on company employees in a subsidiary in a non-English speaking country doing the translation of local language safety reports. Sometimes there may be no one who knows the language of a particular document or publication and thus it must be sent out for (costly) translation. The fewer speakers of a language the more the translation costs.

There is a thriving industry in translations. For example, it has been reported that the average translation cost per page by private translators in Brussels is about 22 euros. Translation in/out of the Irish language is 42 euros per page. Sometimes it is impossible to translate directly from one language to another because few people speak both languages (e.g. Maltese to Danish).

Legal Requirements/Regulations

FDA

The FDA offers a handful of documents aimed at the public in various foreign languages. Not much use to DS/PV.

The FDA has commented in regard to non-English documents submitted to an IND (10/31/2007). The italicized section (my italics) notes that there are no requirements for certified translations.

“Q: I have come upon a question that I would like to clarify. When submitting site registration documents (1572, IRB consent form, investigator CV) from ex-US countries, does FDA have any consensus/guidance on whether these documents must be translated a “certified translator,” and/or if an official certificate of translation is required?

The guidance on acceptability of translated documents is pretty limited–this is an excerpt from the Information Sheet Guidance on Informed Consent:

Non-English Speaking Subjects

To meet the requirements of 21 CFR 50.20, the informed consent document should be in language understandable to the subject (or authorized representative). When the consent interview is conducted in English, the consent document should be in English. When the study subject population includes non-English speaking people or the clinical investigator or the IRB anticipates that the consent interviews will be conducted in a language other than English, the IRB should require a translated consent document to be prepared and assure that the translation is accurate….

How the IRB assures “that the translation is accurate” is really up to the IRB. In other words, the IRB is free to establish its own requirements for translations and the acceptability of translated documents, for example by requiring “certified translators,” or an official certificate. However, the particulars of doing so are really up to them, since we do not have any specific regulations about this.

The regs are also silent with respect to translating other trial related documents. At the very least, the documents would have to be translated for FDA staff, if they are being submitted to us, so the sponsor would want to ensure that any translations are accurate. In any case, it would be up to the sponsor to decide on the method that would make the documents acceptable (e.g., certified translator, use of a specific translation service, submission of an official certificate).”

In two old guidances (1997 and 2004), the FDA notes that if foreign language versions of US labeling are made to an IND, NDA or ANDA they should be submitted with a certified translation. What a certified translation is does not seem to be defined.

The NDA regulations (21CFR314.80) do require copies of medical literature published articles to be submitted to be submitted if the article forms the basis for an expedited report. It does not say if the article is to be translated if not in English.

A search on the FDA website for various terms including “medical literature”, “certified translations”, “translations” did not reveal further information.

EMA

The various EU websites, including the EMA website, have a voluminous amount of information on translations. For example, it notes that safety signals for approved products will be translated into all 24 official EU languages plus Norwegian and Icelandic and “be made available three weeks after publication in English, following a review of the translations’ quality by the national medicines regulatory authorities of the EU Member States.”

This illustrates the difficulty agencies and companies have when they have to translate documents into two dozen or more languages. The translation must be done rapidly by subject matter experts and checked for quality and accuracy. This is complex, time consuming and expensive.

MedDRA

MedDRA has been translated (at some of the hierarchical levels) into has been translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Japanese, Portuguese, and Spanish. If one is using a MedDRA term in a translation the exact term in the other language should be used. This can be done using the 8-digit code assigned to each term.

Certification

Various certifications are possible. There is, as far as I can tell, no single “official” recognized certification. There are some US federal level requirements for the courts for translation of documents but there is no federal level standard set. The French consulate in New York notes “There are no sworn translators in the United States. The profession of translator is not regulated and its practice does not require any validation of professional credentials. There are, however, specific certifications for legal interprets in Federal courts (and in some state courts) but these certifications remain optional. Likewise, the American Translators Association (ATA) delivers a certification that is generally considered a token of professionalism.”

For some this means using a “certified translator” for certain PV and regulatory documents. The US American Translators Association certifies translators. Other countries have other certifying bodies and organizations. France actually does have a lists of established experts who are officially accepted translators (“traducteurs agréés”). Some other countries have similar certifications.

Validation of the Translated Documents

The final area which has changed greatly in the last several years involves the quality and validation of the translation. This comes under the heading of “Linguistic Validation.” This is defined in various ways and also does not seem to be standardized yet. However, the concept is based on Quality Management Systems and ISO 9001:2008 and ISO 17100:2015 on translations.

They outline a rigorous process to validate translated documents:

Forward Translation: This is the translation of the document by two different native speakers of the target language sometimes from different countries. For example, a native francophone Quebecker and a native French person may translate the same article producing two “drafts”.
Reconciliation: This is the “combining” of the two draft translations to produce a meaningful “combined” translation that will be understood by the target audience. This process eliminates local or slang phrases or words that might not be understood (e.g. unique to Quebec or France in this example and not part of “standard” French). This may yield not an exact, word-for-word translation but rather one that captures the meaning of the document.
Back Translation: The reconciled translation is now translated back into the native language by one or two different translators who did not see the original source document.
Finalization: The combined draft and the back translation are compared and a final version is issued.

There are variations on this method especially if the first draft is done by a computer translation that some companies use. This is clearly a robust method that is not used everywhere by everyone. It is very expensive and can be time consuming for large documents. There are many global vendors who do translations. Some specialize in drug safety, PV, clinical trial documents and regulatory documents. They can easily be found with a google search.

Bottom Line for Drug Safety and PV:

Determine what the regulations, laws, guidances and best practices are for translation in your country and in all countries where the document must be submitted. Is submission in English acceptable?
If a translation or multiple translations must be done, determine the rigorousness of the translations needed. Must they all be certified? For a SUSAR, expedited case, study report or a file or dossier submitted to the health agency for study or marketing approval, probably yes. For routine, non critical matters, probably no.
Determine how rigorous a certified translation must be. Different companies offer different levels of rigor and different levels of cost.
Would a partial translation be acceptable such as just the article’s abstract and safety section?
Determine what resources available in your organization. Can it be done in house? Can the local safety officer or another native or non-native fluent speaker do a non-certified translation or even a “quick and dirty” translation to see if there are any SAEs in the article? Could a computer translation work for a “first pass” on the document.
Determine the timing, cost and priority for the translation.
Consider creating an SOP to cover translations.

This has become, perhaps not surprisingly, a rather complex and expensive process. It has a far greater impact on the EU than the US but with the globalization of DS and PV it is more and more an issue everywhere.