How long do you think it takes for a drug to be approved? Around 12-15 years 1. For many, this corresponds to one third of the length of their professional career. How much do you think needs to be invested? Around $1 or $2 billion¹.
However, did you know that just 12% of drugs proposed by pharmaceutical companies are approved by regulatory authorities¹? Millions can be invested without bringing the drug to market due, for example, to failures during laboratory testing or clinical trials, or rejection by regulatory authorities such as the FDA in the United States, the EMA in Europe or INFARMED in Portugal.
Developing a new drug is a highly complex process. Generally speaking, it includes the following phases:
Figure 1 - Diagram of the four main phases of developing a new drug. Adapted from the Congressional Budget Office, 2021 ¹ .
Medical translation plays a key role throughout the entire process of developing a new drug, from clinical trials to submission to the regulatory authorities and the marketing phase.
After all in-vitro, in-vivo and pre-clinical laboratory testing is complete, the clinical trial phase begins. Generally speaking, clinical trials are international to make the sample group more meaningful and representative of reality.
When a CRO (Contract Research Organization) conducts a clinical trial, many documents must be translated into the official languages of each participant²:
Informed consent document:
Document provided to each participant describing all details of the trial. It is extremely important for this document to be properly translated and localized to the target audience in question, to ensure that all participants clearly understand the purpose of the trial, the procedures to be followed, the new drug’s characteristics and the duration.
In addition to translation, some Ethics Committees require the informed consent document to be back-translated into the original language as a means of extra linguistic validation to ensure that the document has been accurately written and translated.
Depending on the requirements of the local regulatory authority, the clinical protocol may need to be translated into the local language.
Packaging and labels:
The information contained in these materials must be translated, reviewed and approved by the regulatory authorities in the countries where the trial is being conducted. New labels must be created and approved for each phase of the clinical trial.
In addition to this documentation, INFARMED requires notification under the following circumstances:
Although all of these documents may require translation, according to INFARMED's recommendations, English is an acceptable alternative to Portuguese ³.
Submission to regulatory authorities
Clinical trials are essential for a new drug to be approved by regulatory authorities. Each country has its own regulations for the sale and distribution of drugs. Anything out of line with local regulations may result in product approval delays, higher costs for pharmaceutical companies, or even having to entirely redo the clinical trial.
This is why localization is crucial in this phase. But what does the “localization” process entail? It consists not only of translating information into another language, but also adapting it to the market and local culture.
Working with a specialized translation agency is therefore a great advantage, since every sentence, word and even unit of measure must be carefully translated and localized. In this case, a minor mistranslation may result, for example, in damaged equipment, or even compromise the health of users.
Pharmacovigilance and marketing
Following product approval by the competent authorities, the drug’s pharmacovigilance phase begins, together with its strategic marketing, bearing in mind its intended target audience(s).
After the drug’s market launch, monitoring its safety is crucial. All SUSARs must be reported to the competent authorities and to the Ethics Committee. According to INFARMED, I.P., English is an acceptable alternative to Portuguese and, for this reason, this documentation may need to be translated prior to being submitted.
All efforts tied to the various phases of the clinical trial and submission to the regulatory authorities are of little use if the product is not properly announced and distributed in the market. In this phase, it is essential to prepare various internal and external communication materials.
The former – internal communication materials – may involve, for example, training manuals for sales teams. They contain all important information for sales technicians and medical detailers to properly present the new drug’s benefits and characteristics to potential customers. The latter – external communication materials – may involve, for example, information brochures, flyers, promotional videos and website content.
Once again, if the drug is marketed in several countries, all advertising and marketing materials must be translated into the official local languages.
The product has now arrived at sales outlets, and is ready to be marketed. This long process of development, testing, approval and marketing always occurs hand-in-hand with the translation and localization of the language. This is the only path to market success.
L10N is a Portuguese company with 20 years of experience offering certified medical and pharmaceutical translation services in 40 languages. These are done by professional translators who specialize in the area of healthcare and are native speakers of the required mother tongue.
¹Congressional Budget Office | Nonpartisan Analysis for the U.S. Congress. Research and Development in the Pharmaceutical Industry, April 2021.
²Medical Translation in Clinical Research, https://www.appliedclinicaltrialsonline.com/view/medical-translation-clinical-research, accessed in October 2021.
³INFARMED, I.P., https://www.infarmed.pt/documents/15786/1539458/Instru%C3%A7%C3%B5es+ao+requerente+-+novembro+2017/136e15e3-dd6d-4cbf-b590-8d69943dde1a?version=1.0, accessed in October 2021.