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August 10, 2026
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EMA Updates Linguistic Review Process for Human Medicines

EMA Updates Linguistic Review Process for Human Medicines The European Medicines Agency (EMA) has published an updated document explaining how product information for centrally authorised human medicines is reviewed before and after marketing authorisation. The process is designed to ensure that product information is accurate, consistent, and compliant across all European Union languages. The document, […]

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August 6, 2026
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FDA Issues New Guidance on GLP Study Report Translations

The U.S. Food and Drug Administration has released draft guidance on the translation of nonclinical Good Laboratory Practice (GLP) study reports into English for regulatory submission. The document is especially relevant for companies, laboratories, and translators involved in international pharmaceutical, toxicology, and medical device studies. Published as Translation of Good Laboratory Practice Study Reports: Questions […]

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February 10, 2026
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As AI enters the operating room, reports arise of botched surgeries and misidentified body parts

Medical device makers have been rushing to add AI to their products. While proponents say the new technology will revolutionize medicine, regulators are receiving a rising number of claims of patient injuries. In 2021, a unit of healthcare giant Johnson & Johnson announced “a leap forward”: It had added artificial intelligence to a medical device […]

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May 6, 2025
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Human Expertise Remains Vital in Medical AI Translations, Experts Say

In a time when artificial intelligence is rapidly reshaping the medical translation landscape, industry experts are cautioning against overreliance on automation. The key message: without human oversight, accuracy—and patient safety—are at risk. As pharmaceutical and MedTech companies race to expand their global reach, the appeal of AI-driven translation tools has grown exponentially. These systems promise […]

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August 10, 2023
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QRD Templates into European Portuguese

One of the most popular requests is the translation and updating of Summary of Product Characteristics (SPCs), Patient Information Leaflets (PILs) and product labels. These documents are crucial for pharmaceutical companies to market their medicinal products in EU countries, and their preparation and translation happens according to strict guidelines. The European Medicines Agency (EMA) is […]

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January 11, 2023
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Translation Trends for 2023

Will post-editing overtake the translation industry? The growth of machine translation has inspired the growth of another service: post-editing machine translation (PEMT). This is where a professional translator takes the machine-translated copy and works with it to enhance its quality. It is an approach that combines the benefits of using computers to translate (namely, speed […]

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November 17, 2020
by in Industry News

Package Leaflets, QRD Templates and Forms

GLOBAL PROFESSIONALS NETWORK Package leaflets Package leaflets enclosed in medication packages are an important source of information for patients or carers about a particular drug, whether prescribed or bought over-the-counter, and should be read before starting treatment and while taking the medication. In addition to providing vital information on indications, contraindications, side effects of the […]

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