Medical Writing Medical Writing Around the World Regulatory Writing
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Volume 22, Issue 2 - Medical Writing Around the World

Regulatory Writing

Abstract

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.

References

  1. 药品注册管理办法 (试行) (局令第35号) Available from: http://eng.sfda.gov.cn/WS03/CL0768/61645.html
  2. 2012中国科技论文统计结果发布. Available from: http://www.istic.ac.cn/EducationDetail.aspx?ArticleID=94468
  3. Editorial. Mod Med J China 2012;14(6):90.
  4. Hui Y, Lihua S. China's drug registration document and ICH CTD: a comparative study. Asian J Soc Pharm 2012;7(3):155–9.
  5. 表2严重不良事件报告表(SAE). Available from: http://www.sfda.gov.cn/WS01/CL0058/9317.html
  6. 药品定期安全性更新报告撰写规范 Available from: http://www.sfda.gov.cn/WS01/CL0844/74864.html
  7. All India Medical Writers Association. Available from: http://aimwa.webs.com/
  8. Japan Medical and Scientific Communicators Association Available from: http://www.jmca-npo.org/
  9. Union of Japanese Scientists and Engineers. Available from: http://www.juse.or.jp/e/
  10. SFDA将加快新药临床审批. Available from: http://news.pharmnet.com.cn/news/2012/09/17/366441.html

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Articles

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

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  • Victoria White (Tampa, Florida, USA) Email: MEW@emwa.org
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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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