PDF Edition - Conducting Clinical Trials in China: Overview of the Regulatory Landscape

November 2011
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Drug companies conduct clinical trials in China for a host of reasons ranging from cost to subject population to accessing China’s growing drug market. But moving into China also poses some serious challenges for sponsors … challenges that are unique to China.

The Chinese approach to GCP compliance and trial site licensing are unique. In addition, approval authorities, ethics committees, and the issues to consider in choosing investigators and trial locations must all reflect China’s unique culture and regulatory structure.

So, what does all this mean to your clinical trial strategy? This new report is where to find the answers.

Here in one authoritative source is what clinical trial sponsors must know before venturing into China. This management report provides an overview of China’s current regulatory landscape and points out key differences from US and European requirements.

Whether you’re a newcomer or already conducting Chinese trials, the report provides fresh updates on how recent government scandals and reorganization are affecting both approvals and enforcement.

In addition to the regulatory overview, you’ll also find practical advice for getting your applications and trials underway and keeping them compliant.

Buy now for sharp perspective on exactly what it takes to initiate and conduct clinical trials in China, including:

  • A clear and up-to-date overview of Chinese clinical trial regulations
  • Guidance on the application and approval process, including how China’s central drug regulatory body approves trials before they move on for ethics committee approval
  • Key differences in the operation of ethics committees
  • How China handles protocol amendments
  • What categories of trials allow companies to consult with approval authorities
  • Eligibility requirements for Phase II and III trials
  • Timing considerations for starting trials in China
  • Tips for selecting Chinese trial sites and investigators
  • Special considerations for operating trials in China

Remember, for drugmakers who can navigate China’s regulatory landscape, the rewards can be breakthrough R&D savings and speedy entry into China’s vast drug market. Don’t wait to get the facts you need now to plan your strategy for tomorrow.

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