With a growing aging population, an estimated 7.2 billion hospital visits per year, an expansive network of qualified hospitals and research sites, and a skilled talent pool of clinical trial project leaders, China is an appealing location for clinical studies.
In terms of the number of clinical trials, China is the second to US now.
Since 2015, China government has implemented favorable policies & regulatory environment to facilitate clinical trial conduct for drug innovation and shorten drug lag in China market for the better drug availability for Chinese patients. accordingly, IND review & approval timeline in China is reduced largely to 60 working days, technically, the requirements are closer to the ICH countries requirements as well to facilitate China being part of global trials and synchronized drug development and marketing approval with global.
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29
Years in China -
2,000
Staff based in China -
FSP
Leading FSP in China -
Labs
Central and specialty lab in Beijing
Local knowledge, global expertise powered by healthcare intelligence
Our services and solutions for all phases of drug and device development include but not limited to:
- Full service and functional services
- Decentralised & hybrid trials
- Early development services
- Site & patient solutions
- Laboratory & imaging services
- Commercialisation & outcomes services
- Symphony Health data solutions
- Mapi Research Trust COA and eCOA services
- Global clinical & scientific operations
- Consulting & advisory services
2025 China biotech sector survey
China’s biotech sector has grown rapidly, powered by decades of centralised planning and strong partnerships. As part of ICON’s latest research, we surveyed 100 biotech leaders based in China, to understand the major priorities and challenges facing them.
Procedural and regulatory know-how for China biotechs in the EU
In this white paper, ICON’s experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA, which allows the marketing authorisation holder to market a drug product in all European Union (EU) Member States, in addition, specific countries in European Economic Area (EEA), with a potential patient pool of approximately 500 million people.
Spotlight on regulatory reforms in China
China’s regulatory reforms have attracted many foreign companies to conduct clinical trials and register their medicinal products in China. However, the evolving regulatory environment and country-specific requirements present significant challenges.
