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From regulatory requirements to patient safety, the medical and pharmaceutical industry has an overwhelming need for translations. While translation is needed in all aspects of the economy, this need is most acute for medicine, medical devices and pharmaceuticals. Package leaflets, informed consent forms, clinical research protocols, summaries of product characteristics, pharmaceutical marketing collateral, patient brochures, instructions for use of medical devices, device user interfaces … the wide range of texts, intended for an even wider range of audiences, makes medical and pharmaceutical translation one of the most demanding areas of expertise a translation agency can choose. A key challenge is to find, choose and follow suitable reference materials to ensure that translations comply with legal and end-user requirements.

Types of reference materials

We at Alamma know from experience that reference materials are the tried and tested way of ensuring quality and consistent translations. This is especially true for medical and pharmaceutical texts, which are terminology-rich and often quite formulaic, like information about medicines for professionals – summaries of product characteristics – and for patients – package leaflets.

Though this is not a formal standard, we find it helpful to think of reference materials in two groups.

Internal reference materials include documents used to keep track of field-specific terminology or client preferences, existing translations or existing client documents in the target language. These are produced by the client, agency or translator.
We regularly compile and use the following materials:

  • Glossaries: (field- and client-specific) lists of terms and definitions.
  • Term bases: (field- and client-specific) compiled using specialised software for linguists to use within their computer-aided translation (CAT) tool. Proven to be most effective of all in ensuring a consistent use of terminology.
  • Translation memories: a database of past translations, prepared for the same client in the same language combination. They ensure consistency between our existing and new translations.
  • Style guides: documents client preferences regarding the style, tone of voice and more formal elements of their texts (metric/imperial units, separators, translation of titles, capitalisation, spelling etc.) depending on the type and target audience. Crucial for marketing texts of all kinds, they ensure unified brand image across all languages.

External reference materials are not created by the client, agency or translator but may still prove as useful or even key sources of information for the translation process.

In medical and pharmaceutical translation, adherence to reference documentation is commonly subject to strict regulation. Non-conformities can be penalised by delays in the application process, extra costs or even rejected applications – those are all issues manufacturers or patients often cannot afford. It is crucial that translation agencies are aware of the industry requirements for translations and follow them as closely as possible.

We have identified three crucial sources for external reference materials for all parties involved in medical and pharmaceutical translations.

1. Product-information templates

Product-information templates are developed by the European Medicines Agency (EMA) Working Group on Quality Review of Documents (QRD). They compile, regularly review and update templates for product information for use by applicants and marketing authorisation holders (MAHs) for human [1] and veterinary [2] medicines. These documents are thus used both by MAHs, or pharmaceutical companies, and by the agencies to whom they subcontract translation services.

Product-information templates must be adhered to at all stages in the process of application for marketing authorisation of the medicinal product, whether the MAH’s text has been submitted for application via the centralised procedure, is related to an ongoing application or to a product that has been authorised. [1]

Product-information templates are available in all EU languages. The version of QRD templates currently in use is v10.2 rev.1 for human medicines (last updated on 8 February 2021) and v8.2 for veterinary medicines (last updated on 31 December 2020). [1,2]

2. European Pharmacopoeia (Ph. Eur.)

This is the most important and exhaustive reference work for the pharmaceutical industry. Currently in its 10th edition (published in July 2019), it is “a single reference work for the quality control of medicines” and provides “a scientific basis for quality control during the entire life cycle of a product”. [3] Its importance cannot be downplayed: it is legally binding in 39 European countries (Council of Europe Convention on the Elaboration of a European Pharmacopoeia), and applied in more than 120 countries worldwide. [3]

At the request of the EU Commission, lists of Standard Terms [4] were drawn up by the European Pharmacopoeia Commission in October 1996. This database “contains terms and definitions to describe pharmaceutical dose forms, routes and methods of administration, containers, closures, administration devices and units of presentation”. [4] The database has been regularly updated ever since, with the latest major update being published on 21 August 2017, and can be used free of charge.

All medical and pharmaceutical translators benefit from using the Ph. Eur. and related peripheral materials to understand their source texts better and render them in the target language as accurately and faithfully as possible. The Ph. Eur, and translations of it provide strong terminological support for a wide variety of pharmaceutical texts.

For Slovenian, the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) published the 5th edition of Formularium Slovenicum on 27 August 2020, the Slovenian addendum to the Ph. Eur. [5] It contains the Slovenian translations of the Ph. Eur., harmonised with the 10th edition and its two addendums, as well as national monographs in effect in Slovenia. Another priceless reference website for linguists translating into Slovenian is the English to Slovenian regulatory glossary, published and regularly updated by the JAZMP. [6]

3. ISO standards

Standards developed by the International Organisation for Standardisation (ISO) represent a distillation of knowledge, expertise and proven processes for many facets of our lives and work, including the pharmaceutical and medical industries. While many are relevant for the translation industry, two are standards are central:

  • ISO/IEC 80000: international standard introducing the International System of Quantities (published in 2009, thus superseding the ISO 1000: International System of Units). This standard has been translated into Slovenian, which is a great contribution to technical terminology in the language and a huge help for translators. [7]
  • ISO IDMP: This is a group of five standards relating to the identification of medicinal products (IDMP), covering the entire medicinal product lifecycle. These standards relate to human medicinal products. They were developed by the ISO and are currently being implemented by EMA. [8] Since EU Member States, MAHs and EMA are obligated to use the ISO IDMP standards, it is wise for the medical and pharmaceutical translation community to pay attention to them, in order to be aware of and apply any potential changes in terminology.

Translation is an incredibly nuanced process, as complex and alive as its subject matter – the language. While some texts and fields allow for more creativity, others – like medicine and pharmaceuticals – are highly regulated. It is important for linguists to be aware of all the reference materials so they can produce as accurate and faithful translations as possible.

The list is by no means exhaustive and there are many more quality sources out there.
Do you know of any other reference materials that we may find useful? Share your knowledge and let us know.

Sources:
[1] https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/product-information/product-information-templates-human
[2] https://www.ema.europa.eu/en/veterinary-regulatory/marketing-authorisation/product-information/product-information-templates-veterinary
[3] https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-10th-edition
[4] https://standardterms.edqm.eu/
[5] https://www.formularium.si/
[6] https://www.formularium.si/brezplacne-vsebine/anglesko-slovenski-slovar/
[7] https://www.sist.si/standardizacija/nekaj-vec-o/standardi-o-velicinah-in-enotah
[8] https://www.ema.europa.eu/en/human-regulatory/overview/data-medicines-iso-idmp-standards-overview