In the past, clinical trials with sites in China came to a grinding halt when they tried to initiate these sites as they had not accounted for the processes required for HGR. It has become known that this process is very time consuming and complex. But did you know that several changes to the legislation have been made throughout the years, aiming to streamline these applications, which now mean the review process is only 20 working days. The HGR application process can still be very time consuming, but the regulatory review part of the process is the shortest piece!

In this three-part series, we will walk you through the journey of HGR and provide explanations and tips to help you with the application process.

In the first blog we describe the background to these regulations and what it means for Sponsors considering international clinical trials with sites in China.

In the second blog, we present the latest updates to these regulations, help you to understand which samples can fall under the definition of HGR, describe the organisation of regulatory bodies overseeing HGR activities, and help you to determine whether you would be defined as a “Foreign Party” or not. (If not, these regulations may not apply to you).

In the third and final blog, we describe the different types of licencing and explain how to save time in navigating the steps involved in applying for the most frequently used licence for international clinical trials.

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