With an aging population, an estimated 4.2?billion hospital visits each year, a broad network of accredited hospitals and research centres, and a deep pool of experienced clinical?trial professionals, China has become an increasingly attractive location for clinical studies.
Today, China ranks second only to the United States in the total number of clinical trials conducted.
Since 2015, the Chinese government has introduced a series of favourable policies and regulatory reforms to accelerate clinical?trial execution, support drug innovation, and reduce the historical drug?approval lag for Chinese patients. As a result, the IND review and approval timeline has been significantly shortened to 60 working days. At the same time, China’s regulatory requirements have been aligned more closely with ICH standards, enabling greater participation in global clinical trials and supporting more synchronised drug development and marketing approvals worldwide.
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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 91黑料’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, 91黑料’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.
