Clinical Real-World Data Pilot Program: Fast-Track Entry Pathway into China

by Grace Wang Apr 12, 2021
It usually takes at least three to five years for innovative new medical products to enter the Chinese market. However, procedure could be much shorter with the application supported by clinical RWD.

China National Medical Products Administration (NMPA) recently granted conditional approval for Blueprint Medicines Corporation's GAVRETO (pralsetinib) through the priority review and approval procedure. 

It's noted that GAVRETO is the first approved drug to use real-world data for clinical evaluation, marking a breakthrough of the Clinical RWD Pilot Program in Boao, Hainan Province.

 What is Real-World Data

Real-World Data (RWD) refers to data relating to patient health status and/or the diagnosis, treatment and health care routinely collected from a variety of sources, according to the Guidelines on Real-World Evidence Supporting Drug Research, Development and Review (Trial) published by NMPA in Jan. 2020.

Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from the appropriate and sufficient analysis of RWD. RWE can support drug supervision decisions by

  1. Offering evidence of effectiveness and safety for new drug approval.

  2. Offering evidence for changes to the labeling of marketed drugs.

  3. Providing evidence for the requirements or re-evaluations of marketed drugs, etc.

The Use of Real-World Data in China

  • In 2018, the State Council authorized the Hainan Provincial Government to approve imported medical devices and drugs (not including vaccines) urgently needed in clinical settings 2. The State Council also permitted the use of innovative drugs and medical devices, which have not been registered in China but have been marketed abroad, in the Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the pilot zone). 3 Thus, the pilot zone has accumulated valuable real-world data through the use of these products.

  • In Oct. 2018, the Center for Drug Evaluation under NMPA extended Bevacizumab Injection's indication based on its real-world data, marking China's first attempt to use RWD to support drug supervision decisions.

  • In Sept. 2019, the National Development and Reform Commission and other three authorities published the Implementation Plan for Supporting the Development of Boao Lecheng International Medical Tourism Pilot Zone 4. The plan proposed to speed up the approval of drugs and medical devices imported to the zone and stated that the clinical data of a small number of these urgently-needed imported medical products can be used for registration applications submitted to NMPA.

  • In Oct. 2019, the pilot zone started the selection of the first batch of products for the Clinical RWD Pilot Program. Three medical devices, including Allergan's XEN Glaucoma Treatment System, entered the program. On Mar. 26, 2020, the XEN Glaucoma Treatment System got approved by NMPA, becoming the first medical device approved using domestic RWD in China.

  • On Dec. 28, 2020, a conference in Beijing announced that the first batch of three drug products (including Blueprint Medicines Corporation's GAVRETO) and the second batch of 11 medical devices became the pilot products for the application of clinical RWD.

Clinical RWD Pilot Program's Benefits to Companies

It usually takes at least two to four years for advanced international medical products to enter the Chinese market. However, procedure could be much shorter with applications supported by clinical RWD. For example, it took Allergan (mentioned above) less than 5 months to get marketing approval for its XEN Glaucoma Treatment System since the product was selected as one of the pilot products for the study on the application of clinical RWD. 

With more successful cases of clinical RWD's assistance in obtaining marketing approval in China, BaiPharm suggests overseas pharmaceutical companies consider the Clinical RWD Pilot Program in Hainan as a quick pathway to enter the Chinese market.

Grace Wang
ChemLinked Regulatory Analyst & Editor
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