European Medicines Agency: Stylistic Matters in Medicinal Product Information

COMPILATION OF QUALITY REVIEW OF DOCUMENTS (QRD) DECISIONS ON STYLISTIC MATTERS IN PRODUCT INFORMATION  
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The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorized in Europe. 

I encounter questions of usage and style and consistency daily in my Chinese to English medical translation practice, so I quite enjoyed poring over the minutiae of their decisions. Here’s what I found interesting from a cultural/linguistic perspective in the EMA's recent QRD decisions on stylistic matters in product information and drug labeling: 

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• ​Avoid the word “should.”  In order to indicate the mandatory nature of the advice in medicinal product information, it is recommended that the word “should” be avoided, wherever possible, in the original English. Convey the meaning equivalent to “must” where instructions to the patient or to the doctor are given. I think it's a good idea to start with the source English to eliminate potential issues in the translation process. Should is problematic in that it is conditional and in some languages its literal translations mean “it would be preferable” or “it is recommended.”
• Abbreviations. Practices differ across Member States on whether to use the full term in English followed by the English abbreviation, as in protease inhibitors (PIs), or to translate the full term and use the English abbreviation. Thorny issue. It can be jarring to see a national language term followed by an English abbreviation: e.g. 蛋白酶抑制剂 (PI) or ácido desoxirribonucleico (DNA).
• Concentrate. In other words, product must be diluted before use. The QRD recommends giving prominence to the term “concentrate” on the outer carton in order to emphasize special handling prior to administration of the product.

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• Active vs. passive vs. direct speech. Considering the wide audience for the Summary of Product Characteristics (SmPC), this document should be written using an indirect style or the passive voice. Direct speech should only be used for instructions about shelf life, storage, handling, and disposal. To conserve space, it is also possible to use direct speech inside tables.
• Special meals. When choosing examples of food to be taken with a medicinal product, ask yourself whether such food is available in all Member States, indeed in all regions across the globe, e.g., applesauce, cranberry juice.
• ​Number separators. Which is preferable? 12.50 mg or 12,50 mg? Depends on the country. Write one thousand as 1 000 and one million as 1 000 000. Groups of digits should never be separated by a comma or a point (period), as these are reserved for use as the decimal sign. Here’s where the non-breaking space (ctrl/shift/space) is indispensable.

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​There’s more! Specifics on the use of Unicode symbols, when to spell out micrograms and when abbreviation is permitted, base units, unit dose pack sizes, and lots of details on maintaining consistency. Subscripts. Superscripts. Additional guidelines on the use of abbreviations.

Read more about these decisions at  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-quality-review-documents-qrd-stylistic-matters-product-information_en.pdf