Medical Writing Medical Writing Around the World Regulatory Writing

Volume 22, Issue 2 - Medical Writing Around the World

Regulatory Writing


This article introduces aspects of the regulatory writing profession in China and Japan. Although regulatory medical writing is at an early stage of development in China, the ever-growing research and development activities in this country have led to an increasing need for regulatory medical writing. In Japan, the Ministry of Health, Labour, and Welfare has made significant changes in recent years in order to address a downward trend in new drug applications due to the lengthy and expensive processes for clinical studies and approvals, and to shorten the lag in the availability of drugs compared to other developed countries. The changes introduced by the Ministry of Health, Labour, and Welfare include a more simplified and efficient approach to clinical studies while improving infrastructure and introducing global standards, such as the International Conference on Harmonisation/Good Clinical Practice. Accordingly, the increased demand for clinical studies has led to an increasing need for medical writing support for regulatory documents in Japan. Both China and Japan have their own regulatory authorities equivalent to the United States Food and Drug Administration, but there are also marked differences leading to challenges and opportunities for regulatory writing.

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Medical writing around the world
Message from the President
The yin and yang of medical writing in China
The changing face of medical writing in India
Medical writing in India at a crossroads
Medical writing in the Middle East
Medical writing in Finland
On the western edge of Europe – medical writing in Portugal
Announcing AERTeM, the Spanish Association of Medical Writers
From editors abroad into businesswomen back in Brazil
Science writing workshops for AIDS vaccine researchers in Africa
Medical postcard from Australia, the world's largest island
Teaching English for Medical Academic Purposes at the Faculty of Medicine in Belgrade, Serbia
Regulatory medical writing in Switzerland
Medical writing in the Russian Federation: Promises and pitfalls
Report on the EMA Workshop on clinical trial data and transparency
Potential implications of wider data transparency in medical communications
The need for registration of preclinical studies
Mentorship in EMWA: A perspective
In the Bookstores
The Webscout
Regulatory Writing
English Grammar and Style
Medical Journalism
Medical Communication
The Light Stuff
Out On Our Own


The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

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

Layout Designer

Chris Monk