Parexel announces partnership with Ruijin Hainan Hospital to progress real-world evidence in China

Working with Ruijin Hainan Hospital, Parexel will utilize the Hainan Real World Evidence Pathway program to facilitate the collection and analysis of real-world data, thereby accelerating the approval and availability of new treatments for patients in China.

Parexel has recently announced a collaboration with Ruijin – Hainan Hospital Shanghai Jiao Tong University School of Medicine Hainan Boao Research Hospital (Ruijin Hainan Hospital) to utilize real-world data (RWD) and real-world evidence (RWE) collected from clinical practice, patient experience, and other sources within the hospital system to accelerate the approval and introduction of new medical treatments in China.

On the announcement, Sheng Feng (Corporate Vice President, Real-World Evidence, Asia/Pacific, Parexel) noted:

“We are excited to collaborate with Ruijin Hainan Hospital, a premier healthcare institution known for its excellence in patient care and medical research, to bring innovative solutions to the Chinese market. By combining Parexel’s global reach and unparalleled experience with Ruijin Hainan Hospital’s medical expertise and access to RWD/E, we believe we are well-positioned to advance drug development in China.”

The initiative is part of the Hainan Real World Evidence Pathway program, also known as the Hainan Boao Lecheng International Medical Tourism Pilot Zone or the Boao Lecheng Pilot Zone. This program permits the use of medical devices, in vitro diagnostics, and drugs with overseas approval to be used in the Hainan Province of China before they receive full national regulatory approval by the National Medical Products Administration (NMPA). Once a product is approved for use in the pilot zone, manufacturers can gather and utilize RWD from local clinical settings, such as hospitals, to support clinical development and full regulatory approval. The unique regulatory pathway allows RWD/E to be used in regulatory decision-making by the NMPA, expediting market access in China and providing patients with earlier access to treatments. As of July 2022, 24 licensed drugs and medical devices with overseas approval had been included in the program.