The importance of standards for translations

In a globalised world, harmonisation and standards are key elements allowing the acceptance and circulation of goods, systems, methods and applications. A standard is a shared modality enabling to do something in a repeatable way, yielding an outcome that is always the same. Internationally acknowledged standards in all fields allow more efficiency, absolute compliance with established requirements and a high level of quality.

Standards can be of different nature: more often, they are criteria, methods, procedure guiding in the making of a product or service, fixed at international level by special committees, frequently referring to an international organisation. They are also continuously updated to keep pace with the progress of new technologies and with the specific needs of the market and society.

Standards can have different functions, based on the sphere they intend to regulate. Therefore, they can provide general information, or describe in details processes and operative methods. Sometimes, however, they are only lists defining, at international level, some commonly used terms. This is the case of the standards establishing the translation into more languages for some terms used in specific technical and scientific environments, such as the EDQM standard terms.

EDQM is the acronym of European Directorate for the Quality of Medicines, a European organisation operating inside the Council of Europe, located in Strasbourg, mainly dealing with public health protection via a series of tools and policies enabling the development – and supporting the implementation and monitoring – of quality standards ensuring the safety of medicinal products.

The EDQM carries out inspections and releases certificates of conformity, coordinating a network of laboratories (OMCL – Official Medicines Control Laboratories), also including the Italian High Health Institute (Istituto Superiore di Sanità). The EDQM cooperates with national authorities to fight against counterfeiting and falsification of medicines and provides approaches and guidelines on a safer use of drugs.

Above all, the EDQM establishes standards: for blood derivatives, products from tissues and organs, including any relevant procedure (transfusions, transplants, etc.); for cosmetics and food contact materials; and, of course, also for medicinal products.

Actually, the list of scopes that are part of the EDQM mission clearly specifies the establishment of official standards for the manufacturing and quality control of medicines in all countries that signed the Convention on the Elaboration of a European Pharmacopoeia.

These standards also include a database containing terms and definitions describing pharmaceutical forms, routes and methods of administration, types of containers and closures, administration devices and units of presentation. For each term, the database provides a summary sheet, a series of details, linked terms and translation into 34 languages: Albanian, Bosnian, Bulgarian, Chinese, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Italian, Kazakh, Latvian, Lithuanian, Macedonian, Maltese, Norwegian, Polish, Portuguese, Romanian, Russian, Serbian, Slovak, Slovene, Spanish, Swedish, Turkish and Ukrainian.

The database also includes some “patient-friendly” terms that authorities can accept in some cases, as well as a series of term combinations to describe two or more items packaged together, or when a pharmaceutical dose form and a container are strictly related.

This is, therefore, a precious tool that makes the work of medical and scientific translators easier, and that ensures appropriate understanding of the pharmaceutical jargon all over the world. Standards become essential also in the frame of translations, in particular in the translations for the pharmaceutical sector, as they guarantee the harmonisation, correctness and reliability of the translation: a further tool made globally available by the authorities to protect patients’ health.

Written by: Maria Pia Felici

Foto di MonikaP da Pixabay