The impact of pharmaceutical translation in the USA

Pharmaceutical translation shares many characteristics with medical translation, since, if it is not accurate and correct, the consequences can be very serious. Thus, when working with pharmaceutical texts, special protocols and procedures must be followed to guarantee the quality of the service offered.

When we talk about pharmaceutical translation, we are talking about all documents used in the pharmaceutics sector. Thus, clients can be research organizations, laboratories or drug manufacturers, as well as medical journals or pharmaceutical publishers.

This is one of the most demanded modalities, both for being a sector in constant expansion and innovation, as well as the high production and commercialization of pharmaceutical products.

Regulation of pharmaceutical documents

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The European Medicines Agency (EMA) and the Committee for Medicinal Products for Human Use (CHMP) are the two bodies that assess the quality, safety and efficacy of drugs in order to allow them to be marketed in Europe. In addition, they regulate the information to be included in the technical data sheets, labeling and package leaflets of medicinal products.

In fact, Directive 2001/83/EC requires package leaflets and labeling to be written in the language of the country in which the medicinal products are marketed, as specified by each Member State. It also establishes the form in which they should be written in accordance with the function and format of the drug.

Thus, from the manufacturing process of a drug to its commercialization, there are several times when the services of a translator are needed.

Types of documents

Some of the documents covered by pharmaceutical translation are: package inserts and technical data sheets, pharmaceutical studies and research, chemical patents, clinical trials, laboratory documents, labeling and packaging, specialized articles published or to be published in scientific journals, industry papers, advertising, herbalists, cosmetics, perfumery, etc.

Special features of the pharmaceutical translation field

The pharmaceutical industry works at a very fast pace, and often the introduction of drugs to the market must be just as fast, either because they are new drugs resulting from research by pharmaceutical companies or because they are generic products launched after the expiration of patents.

Some of the essential requirements for pharmaceutical translation are speed, accuracy, terminology knowledge, expertise and confidentiality. It is therefore essential to entrust the translation of this type of document to a team of specialized professional translators who are used to working under these conditions, have terminological consistency, efficiency and extensive knowledge of the special protocols of this sector.

Consequences of translation errors

Pharmaceutical translation by fasttxt.esIt is important to remember that the pharmaceutical field directly affects health, so the margin of error that is allowed is practically zero. The consequences of a translation error could be extremely serious.

An example of this is the translation of package inserts and technical data sheets. These specify the dosage of the drug, as well as its benefits and contraindications. Thus, a translation error could change the dosage, causing problems with the doses taken by patients. In addition, some drugs can be potentially dangerous if they interact with certain products, while others must follow a rigorous administration at specific times.

Therefore, an unfortunate translation error can lead to the prohibition of the marketing of a given drug or pharmaceutical product, with the financial losses this entails for the pharmaceutical industry.

Features of a good pharmaceutical translation

As we know, pharmaceutical translation requires a high degree of specialization in pharmaceutical terminology, as well as chemistry, biochemistry and even medical terminology.

Therefore, a good translation should contain clear and concise language that does not leave room for free interpretation. In a document with such technical precision, word games and metaphors have no place.

The constant updating of the sector and the high content of specific terminology require a translator specialized in the industry, as well as a high level of documentation skills.

Likewise, the communicative capacity of the translation directly affects the brand image and its reputation. Ultimately, if the package insert is not clear, the patient or user may choose another drug in the future.

Impact in the USA

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The pharmaceutical industry is more essential than ever. The advance of almost unknown diseases has made it increasingly necessary to have the appropriate pharmacological tools to treat them. It is in this field that pharmaceutical translations become essential.

Operating on a global scale, the U.S. pharmaceutical industry produces more materials and drugs than anywhere else. Thus, it must provide documentation translated into several languages in order to be able to market them. Whether it is regulatory submissions, patient information leaflets or packaging labels, all must be translated to avoid complications when registering your drugs in foreign markets, which are ruled by strict regulatory bodies or government agencies. Thus, pharmaceutical translation enables these U.S. companies to meet all the requirements necessary to successfully complete their work.

Mercedes Pajuelo