Medical Writing EU Regulations The new PubMed – underestimated regulatory obstacles

Volume 29, Issue 3 - EU Regulations

The new PubMed – underestimated regulatory obstacles


NCBI´s PubMed is a powerful literature retrieval tool widely utilised in many areas including science and regulatory affairs. In regulatory affairs, PubMed searches are employed to identify clinical evidence pertinent to product approval processes. To ensure traceability and reproducibility, a highly structured literature search strategy is advised, as laid out in numerous guidance documents issued by regulatory agencies such as the European Commission and the International Medical Device Regulators Forum. Recently, a new version of PubMed was deployed, including a new user interface and, less visibly, potential changes to search algorithms, which may affect the results delivered by search strings. To unravel potential differences among the legacy and new version of PubMed, head-to-head comparisons with increasing search complexity were performed. For the new version of PubMed, the user interface was redesigned and allows feature customisation. Importantly, as compared to the legacy version of PubMed, the new PubMed delivered diverging numbers of search hits. Of note, the PubMed inherent result sorting methods produced alternating search hit numbers only in the legacy version. Intriguingly, each version identified literature that was not found by the respective other version, although these publications were considered relevant in the search context. Technically, translation of entered search strings into detailed search strings varied between interfaces. Differences between the legacy (online at
least until September 30, 2020) and the new version were found, affecting the traceability, reproducibility, and reliability of PubMed data used for approval processes.

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President's Message
The In Vitro Diagnosgtics Regulation and the role of medicals writers
Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR
Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers
New documents required by the medical device regulation
Risk management plans in the EU: Managing safety concerns
Scientific advice procedures in the EU – an overview ofthe regulatory background
EU software regulations: The new normal or innovation stagnation?
The new PubMed – underestimated regulatory obstacles
Ethical challenges in acknowledging professional writing support
Publication management software for medical writers
Regulatory Matters
News from the EMA
Medical Devices
Medical Communications and Writing for Patients
Getting Your Foot in the Door
Lingua Franca and Beyond
My First Medical Writing
In the Bookstores
Good Writing Practice


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Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

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Chris Monk