GCT recently expanded its Asia coverage to China, where we cover a total of 28 provinces, autonomous regions, and municipalities. All CRAs have ICH-GCP training certificates and minimum clinical trial experience of 3 years. All PMs have over 5-year experience.
China is the second biggest pharmaceutical market in the world. It is an attractive country for clinical trials due to its large pool of treatment-naïve patients and local experts. There have also been regulatory improvements recently – China’s National Medical Products Administration (NMPA) introduced updates to its review process. From IND to approval, the cycle takes about 5 to 6 months. The timeline includes preparation and scheduling of a pre-IND meeting, and communication with NMPA before the submission continues through to approval. There is also government support for international partnerships along with the improved regulatory environment for trials and new drug approvals.
With many established clinical trial sites employing expert teams, a robust network of experienced specialists, and advanced technologies in use, there is a sturdy foundation to support clinical trial operations successfully in China.
Due to rapidly growing numbers of clinical trials in China as well as the global impact of the pandemic, the Chinese Center for Drug Evaluation (CDE) expanded the Regulatory Guidance on mandatory submission of clinical trial data and associated documents in an electronic form in January 2022.
Given the digital trends in the pharmaceutical industry and the complexity of eSubmission operations, eSubmission/ eCTD Team was set up in 2019, and successfully completed its first eSubmission project in February 2022. Since January 2022, more than 10 eSubmission projects have been completed, of which the largest project comprised 100,000 pages + (domestic NDA) and the smallest one – more than 100 pages (US FDA Annual Report).
It is evident that the pharmaceutical market in China has experienced significant growth, driven by a large population, and increasing healthcare needs. Conducting a clinical trial in China offers access to a diverse patient pool and potential for accelerated recruitment. However, navigating regulatory processes, ensuring data integrity, and understanding cultural nuances are crucial for success in this dynamic and evolving landscape. Collaborating with local experts and adherence to China’s regulatory framework are key considerations for a seamless clinical trial experience in the country.