Because China is a highly active market in the areas of life sciences and pharmaceutical development, Chinese pharmaceutical translation today is critical. The country is a growing consumer of medical services and products from abroad and the demand for pharmaceutical translation services is higher than ever. This is supported by the fact that China’s high level of activity in clinical trials is raising the demand for such translations.
But apart from clinical trials, there is much research and development done in the biotechnology market, which is estimated to reach $700 billion by 2025. Therefore, when it comes to Chinese pharmaceutical translation in particular, it’s essential for translators to be properly equipped to translate the details of different drugs (including the packaging and the leaflet), medical technology, clinical trials, regulatory documents and compliance, drug marketing, traditional medicine, international drug discovery, medicine manufacturing, patient communication, and others.
With this in mind, we’ve set out to answer some critical questions when it comes to Chinese pharmaceutical translation. In this article, we will cover what pharmaceutical translation entails, what the related industries are, what skills good translators need to have, and the challenges involved in doing Chinese translation for the pharmaceutical industry. Let’s get started.
What does pharmaceutical translation entail?
Broadly speaking, pharmaceutical translation is the process of translating and localizing every aspect of the life sciences processes, procedures, regulatory requirements, product outcomes, and more for several reasons. Firstly, there is greater demand for cross-border pharmaceutical trade. Secondly, the process can be extremely costly for manufacturers and those involved in research and development. Thirdly, a mistranslated or mislocalized word can have serious implications for patients, including injury and/or death. Therefore, precision when it comes to doing pharmaceutical translations is not only a must. It’s essential.
Further to the above, and delving a bit deeper into what a pharmaceutical translation is, we must point out that it involves several aspects that need to work cohesively with each other. For starters, a pharmaceutical translation may entail the summary translation of Product Characteristics, which is used by doctors, pharmacists, and professional nurses. This is essentially the “identity card” of a particular drug and it contains relevant information related to its validity, efficacy, and safety. It may also require periodic changes to keep up with changes that have been made to the drug.
Another important aspect involved in pharmaceutical translation relates to translating the package leaflet. This is the leaflet that is packed within the package of the drug and it contains all the relevant information for accurate and correct uses. It contains details such as composition, dosage, use and storage methods, interactions with other medicines/substances, and potential side effects. Since these leaflets are aimed at patients, they need to be understandable and absolutely clear.
Despite these two brief examples, the pharmaceutical industry follows “Good Manufacturing Practice”, which requires documentation through the drug manufacturing life cycle. This means that there is a need for clear and unambiguous pharmaceutical translation at every step of the process including the use and details of chemical substances, production procedures, and potential risks to the patient.
What translation services are related to the industry?
Pharmaceutical translation services are not just about product leaflets and external packaging. In fact, the process is highly complex and the space is not as easy or straightforward to navigate as one may assume. This is because pharma translation deals with the industry in a broad sense. This may include the need for translation services that, apart from drug leaflets and packaging, relate to:
- Texts from clinical research laboratories
- Dossiers issued by regulatory offices
- Documents issued by/aimed at government bodies
- Obtaining marketing authorization
- Translation of articles for specialized journals and scientific publications
- Drug inserts
- Informed consent forms
- Clinical trial protocols
- Chemistry, manufacturing, and controls (CMC) documents
- Medical patents
- Patient-reported outcomes
- Quality of life best practice documents
- Pre-trial monitoring reports
- Lab/technical procedures
- Investigator’s brochures
- Informed consent forms
- Quality assurance documents
- Standard operation procedure (SOP)
- Production batch records
- Training materials
- Product glossaries
- Case reports
- Protocol documents
- Brochures
- Instructions
- Synopses
It should be clear from the above that pharmaceutical translation services require both extensive and broad knowledge of the life sciences industry and that pharma translation is also highly niche and specific. Each item specified above needs to be translated and localized with precision and accuracy to avoid serious and costly mistakes. In fact, when it comes to pharmaceutical translation, there is no scope for errors.
What type of skills are required to be a translator for the pharmaceutical industry?
Undertaking pharmaceutical translations is therefore no small task. Skilled translators should therefore possess strong skillset when embarking on this endeavor. Examples of skills that they should be highly competent in include:
- Constantly keeping up to date with regard to regulations that govern the international pharmaceutical system
- Keeping up to date with scientific terminology
- They must be specialists in the field
- They must be able to work with experts in the field
- They must be native medical translators
- And a lot more.
China and Chinese-language-specific challenges
With specific regard to Chinese pharmaceutical translation, several challenges arise in this highly complex and ever-evolving industry. It’s not just a matter of doing a Chinese translation because this will simply be insufficient in terms of the quality controls required. Instead, accurate and precise Chinese pharmaceutical translation is essential. With this in mind, we have prepared a list of some important challenges that drug manufacturers and other related stakeholders may face when it comes to Chinese pharmaceutical translation.
- The rules involved: although China is said to be relaxing some of its regulations regarding the speed with which new drugs are licensed for use, there are some other regulations that foreign companies must bear in mind as they seek to enter the market. For example, a current requirement is that clinical trial data from overseas will not be recognized in China and new trials need to take place within the country to enable foreign companies to secure a share of the market. However, if this rule is relaxed, Chinese pharmaceutical translation will see a significant uptick in demand as foreign companies attempt to secure greater access to the Chinese market.
- A shortage of skills: when it comes to Chinese pharmaceutical translation, there may be a good supply of people who can do Chinese translation. However, the number of skilled translation professionals who can not only translate in various dialects and versions of Chinese (simplified or formal) but who also have experience with medical and pharmaceutical translations is slim. It’s also important to note that there is already great competition for skilled translators and this is another reason why Chinese pharmaceutical translation may face some setbacks despite great demand.
- Traditional vs. conventional medicine: there is not only high demand for conventional medical services in China. Traditional medicine is a massive market, too. However, finding the right translation professionals to carry out accurate Chinese translations is slim and has, in the past, led to misleading information and a lack of credibility. This is because the complex cultural and linguistic nuances which refer to the body and to its relationship to medicine have been found lacking. Therefore, despite the fact that aspects of traditional medicine such as acupuncture, medical massage, nutrition, and herbal remedies are important for Chinese people, these medical approaches are often not translated in a skillful enough way for better results and accuracy.
Overcoming the Challenges of Chinese Pharmaceutical Translation
Pharmaceutical translation services which specifically require Chinese translation are growing in demand because of the changing rules related to medicine and medical technology in China. However, despite this, there is a lack of skilled professionals who can undertake Chinese pharmaceutical translation in a professional and high-quality manner. Further to this, the challenge of translating traditional medicine and its nuances into other languages poses a further challenge. However, with the right translation partner at your side, this challenge can easily be overcome.