Chinese Pharma Clinical Trials Discussed by Access China in New Study Published at

21 Jul 2014 • by Natalie Aster

LONDON – Over the past 20 years, China’s healthcare marketplace has managed to maintain average annual growth rate of over 16%, owing to stable economic and population growth and also an aging population. In 2013, the total value of China’s pharmaceuticals sector has reached RMB 1114 billion, and it is forecast to be over RMB 1450 billion by 2015-end and outrun Japan to become the 2nd biggest drugs market only giving way to the USA. Within China’s healthcare market space, foreign-made drugs imported to the country comprise about one fourth of the pharma sector.

More and more multinational and overseas pharmaceutical manufacturers are passionately carrying out clinical trials for their drugs in China to capture a larger portion of such drugs market. However, the Chinese approach to Good Clinical Practice (GCP) compliance is unique, from the application and drug approval process, the requirements for sponsors, investigators and ethics committees to the application dossiers. To enter into such a lucrative and complex market, most overseas and multinational pharma companies should have extensive knowledge of the most recent Chinese regulations on clinical trials. Otherwise, the restrictive legislative requirements and delays in approving novel medicines eat away their development time and budgets.

New study “Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)” developed by Access China Management Consulting (Access China) provides a thorough understanding of the latest Chinese regulations on clinical trials for registration of imported drug products.

The report reviews the Chinese applicable laws and regulations for drug clinical trials; looks at the organisational structure of Chinese regulatory authorities for clinical studies of drugs; presents Chinese definitions of some relevant basic terms, alongside the Chinese unique drug registration classification; describes every party’s responsibilities in clinical studies for imported drug registration; examines the complete process of application and approval procedures for clinical studies of imported drug registration; offers the practical guidance for clinical trials of imported chemical medicine product  registration, of imported biologics registration, as well as of imported natural drug and traditional Chinese medicine (TCM) registration. The study is supplemented with a set of full text in English of China’s regulations and laws for pharmaceuticals clinical studies.

Report Details:

Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)
Published: July, 2014
Pages: 191
Price: US$ 1,495.00

More new reports by the publisher can be found at Access China page.


The Market Publishers, Ltd.
Natalie Aster
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