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Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre? - Volume 24, Issue

Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on…

EMA Foreword - Volume 32, Issue

The EU Clinical Trials Regulation and its much-anticipated benefits: Foreword from the European Medicines Agency The year 2022 signalled the beginning of a new way of handling clinical trials in Europe, with the implementation of the EU Clinical…

Regulatory Matters - Volume 32, Issue

Current clinical trial disclosure landscape in China Author and Section Editor: Zuo Yen Lee Section Editor: Clare Chang In China, before the launch of the current national clinical trial registry in 2013, i.e., ChinaDrugTrials.org.cn…

Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved? - Volume 33, Issue

Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…

In the Bookstores - Volume 21, Issue

A personal view incorporating the insights of a UK-based book group Henrietta Lacks was a 31-year-old African American who died in 1951 from cervical cancer. Her biopsied cancer cells were taken without her permission, propagated seemingly forever…

English Grammar and Style - Volume 21, Issue

Pleasing the reader The fundamental principle in the practice of medicine, ‘first, do no harm’, could be transposed to the world of medical writing to ‘first, do not annoy’. The Good Writing Practice (GWP) group at EMWA has been focussing on…

Lessons learnt from PETHEMA’s RWD research: A clinical perspective - Volume 34, Issue

PETHEMA (Programa Español de Tratamientos en Hematología, or, Spanish Program for Treatments in Haematology) a leading cooperative group in haematological research, has increasingly integrated real-world data (RWD) as a complement to traditional…

Regulatory Public Disclosure - Volume 30, Issue

Editorial In the first half of 2021, keeping up with the regional regulators’ activities on COVID-19 medicines became a competitive sport. FDA’s Emergency Use Authorizations (EUAs), EMA’s Conditional Marketing Authorisations, and Health Canada’s…

Journal Watch - Volume 26, Issue

Data sharing is encouraged by institutions and journals: Authorship of “shared” papers should be clearWhen researchers share data, the teams analysing them want to publish their results. How should authorship of publications be defined? Who are the…

Leveraging infographics in study schemas - Volume 29, Issue

Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…

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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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