Key points to Consider when Translating for the Pharmaceutical Industry
Translating for the pharmaceutical sector is highly specialised work, so there are a number of issues and developments to consider. For example, one of the key ongoing developments in the pharmaceutical world is the expansion of Asian markets. The Indian and Chinese drug markets are growing exponentially, as are those of many smaller South East Asian countries. Adapting to these markets is not always easy for Western companies; in the same way that they must adapt the product they sell, they must also change the way they think about translation and localisation.
In addition, recent years have seen the global consolidation of many leading pharmaceutical companies. This has taken the form of acquisitions and mergers among various pharmaceutical companies. As a result, many of these mergers have created multi-national companies which work in various different regions and language areas.
Another key change in the pharmaceutical industry is the increasing role of generics, with many voices arguing for the sale of ‘branded generics’, particularly for the less cash-rich economies of Asia. With a market size worth $535.8 billion, it is essential that your company responds to local markets in an appropriate way; and adjusts every aspect of its approach to the local culture.
Multilingual documentation is essential in one of the most tightly-legislated industries in the world. Translation may be required at any level, including clinical research, regulatory submission and review, production and marketing.
Europe and the EMEA
In Europe, expansion of the EU is also driving increased demand for medical and pharmaceutical translation services. In EU member states, in addition to the requirements of the country’s own drug regulatory authority, companies must also meet the requirements of the European Medicines Agency (EMEA).
The EMEA sets a strict time frame of 20 days for translating versions of approved pharmaceutical documents. Firstly, you must submit initial translations within five days of the marketing authorisation being given by the CPMP (the EMEA committee responsible for assessing marketing authorisations). By the 20th day, the final revised versions of the translations must be provided to the EMEA, in their final format.
Labels in medicine bottles contain diverse information like dosage, storage instruction, side effects, warnings, frequency of use, expiry date etc. When these medicines are sold in a multilingual market like the European Union, they need to be accurately translated in the local language of the country they are to be sold in. The EU has issued several directives, such as the medical device directive, clinical trials directive, in-vitro diagnostic directive. These directives make it mandatory to translate medical labels into the language of the market in which products will be sold.
Translators within the European pharmaceutical industry must therefore be experts in European regulatory submission; as well as having experience with the latest Quality Review of Documents Groups (QRD) Templates. QRD templates are a set of documents whose main objective is to set out standard phrasing, terminology, and stylistic preferences for product information as well as to provide guidance on layout.
Multilingual documentation is required for:
- Summary of Product Characteristics (SmPC)
- Patient Information Leaflet (PIL)
- Marketing materials and web content
- Market Studies
- Case Report Forms (CRF)
- Patient Guides
- Patient Questionnaires
- Informed Consent Forms (ICF)
- Clinical Trial Materials
- Doctor Guides
- Lab Reports
- Manufacturing Specifications
- Regulatory Documents
At QuickSilver Translate, we offer specialised translation services for the pharmaceutical industry, using qualified, professional translators, with experience and expert knowledge in this area.