Translators understand the delicate and sensitive nature of all translation works. They cannot afford to make any mistake because the consequences can be quite disastrous for the client. It requires double the effort when it comes to medical translation, which has many types. One such type is pharmaceutical translation that has its own very particular niche among translation services, due to its critical and sensitive nature. This is one type of translation where even the slightest mistake can result in consequences that are irreversible, such as injury or loss of life.
Medical translation has many applications in the field of field of health services and in the medical and pharmaceutical industries. The demand for professional medical translators and translations for the pharmaceutical industry has increased because of the consolidation of pharmaceutical companies in recent years.
Let us focus on the pharmaceutical industry. With the global operations of the pharmaceutical industry, the demand for top-quality and accurate pharmaceutical translations has also gone up. The requirements vary as well, adding to the pressure on specialized medical translation organizations. The global marketing authorization approvals come mainly from the U.S. Food and Drug Administration (FDA), the Pharmaceutical and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA).
Documents that need medical translation
Patents and clinical trials are some of the documents that usually need translation. While these are the main documents the pharmaceutical industry often requests translations for, there are several documents that require translations, too. Some of these include protocol documents, synopses, brochures, case reports, training documents, label text, pharmacological instructions, packaging text and informed consent forms.
Translating these types of documents is a very difficult task and requires a Subject Matter Expert (SME). There are many regulations in the industry, from the country of origin to the different markets worldwide. The regulations cover many areas starting with the development of pharmaceutical products down to their marketing.
Drug registration is not allowed until manufacturers submit the pertinent translated and localized versions of all the necessary documents. Approval rests on the submission of the translated package leaflets, the labeling printed on the vials, bottles or blister packs and the summary of the medicinal product characteristics (SmPC) that is printed on the outer packaging.
The SmPC is the most critical among these three important documents. This summary provides the details of the specific drug’s characteristics and purpose. It’s the comprehensive and official description of the product. It includes the pharmaceutical forms of the drug, the dosages, uses, composition and its active ingredients. It also lists down all the known adverse reactions and effects of the drug.
A lengthy process
Translating SmPC alone takes a long process. There is usually a pre-opinion phase where quality assurance is checked at source. The translation provider must do a detailed review of the SmPC, package leaflet and labeling in its English-language version. The medical translation agency will be working closely with the clients on the quality of the source documents. This is to ensure that the market requirements of the target language/s are met. The agency must consider the format and layout, the content standards and even the style guidelines for the product.
The SmPC is critical for the development and approval of the drugs. It is also the source of information for all health professionals, especially in the effective and safe prescription and use of the medicine. It must pass the approval of the drug regulatory authorities of all the countries where the drug will be marketed. Moreover, it is the basis for the creation of the Patient Information Leaflet (PIL) that is included into individual drug packs. The Regulatory Affairs Departments of pharmaceutical companies write and update the SmPCs.
Although the information contained in the SmPC is the same as that in the PIL, the latter will have to be written in a manner that can be quickly understood by people with non-medical background.
Layers of quality control
Medical and pharmaceutical translations rely on the expert knowledge of translators and wealth of information on the latest technology. There should be an oversight team and multiple layers of quality control to see to it that there will be no mistakes. The medical translation should be 100% accurate because health professionals and patients around the world depend on the accuracy of all the pharmacological literature to guide them.
Complications
Medical translation and pharmaceutical translation are decidedly complicated. Aside from the language pairs, the industry also has its own set of terminologies, acronyms and abbreviations that may differ in word order and spelling in various languages. In the EU alone, there are 23 officially recognized languages. If there is more than one language in use, it is imperative that all the texts must appear in all the languages, and each content must be the same across all languages. The EU is also very strict in adhering to the timetables they’ve set.
Research and critical trials are mostly done in other countries, not in the country of origin, necessitating the translation of documents from the beginning. Due to tight competition, translation of pharmaceutical documents becomes very time-sensitive. Drug companies sometimes often compete for the same drug process or product. It is therefore necessary that pharmaceutical and medical translations are not delayed because it can mean lawsuits, rejections and backlogs. Add to the list its effect on human welfare and health and losses in money and time.
What to look for in a medical translation company
The reputation of the medical translation agency is very important here because it is essential to satisfy the timeliness and accuracy requirements of the company. The translation company should have the right subject matter experts who are native speakers as well. Deep knowledge of the terminologies plays a big role in making the translation accurate. Knowledge of the culture of other target markets also greatly matter in the multi-layered quality review. This is when the translation agency will check the quality and accuracy of all the details. Things to check include the syntax and grammar of the target language/s and industry-specific text. These are also the qualities that only human translators can deliver, which are signs of high quality translation services.