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Over the past year, Citeline has been monitoring 360 public Chinese hospitals (excluding military hospitals) that have been certified to conduct clinical trials for consideration for regulatory submission to the China FDA (CFDA). These CFDA certifications are specific for a disease, therapy area, or treatment/diagnosis modality and are awarded for three-years duration. Certifications have been awarded to hospitals practicing Western medicine, traditional Chinese medicine (TCM; as well as Tibetan and Mongolian medicine), or a mixture of both.

 

 

Historically certifications were awarded predominantly to tier 3A hospitals, the highest official tier and grade level. (China’s public hospitals are assigned a tier and grade level that reflect hospital size, infrastructure, ability to provide medical care, medical education, and conduct medical research.) We have observed movement of certifications awarded into the mid-sized tier 2 hospitals, and even to the smaller tier 1.

 

 

During the last year, approximately 80 additional hospitals have received CFDA certifications. Even more recently — within the last three weeks — the CFDA released an updated list of certifications that included award and expiry dates. This recent CFDA update reveals that 35% of the total certifications awarded have expired, impacting all provinces as shown in Fig. 1.

 

 

At the hospital level, the recently released certification information reveals impacts for every province. Certification expiries have occurred across nearly every province. Fig. 2 provides a snapshot as of early December for the monitored 360 hospitals’ certification status as active, fully expired or a mix of active and expired, or undetermined (award/expiry date information unknown). Nearly every province has a larger proportion of fully active certifications compared to those that are fully expired.

 

 

China-site-selection-Chart

Source: Chinatrove®, 2014 Citeline

 

 

The fluidity in hospital certifications runs across all hospital tiers and grades; it also crosses Western and non-Western medicine hospitals or departments, as shown below. As illustrated in Fig. 3a, the lion’s share of certifications has been awarded to hospitals whose certifications are for the practice of Western medicine – for either diseases or procedures such as imaging or surgery. But a not insignificant number of hospitals have been awarded certifications for TCM medicine areas, and certain hospitals have been awarded a mix of both types of certifications. But for all hospitals, nearly 70% of Western and TCM hospitals have active certifications (fully active or a mix of active and expired).

 

 

China-site-selection-Chart-3

Source: Chinatrove®, 2014 Citeline

 

 

It is promising that the CFDA is expanding to award certifications to lower tier and grade hospitals, and expanding from the largest cities to include mid-tier and even small-tier cities. Also noteworthy is the very recent transparency of the certification and expiry dates. However, with the short award time of three years, it seems clear that recertification will be needed as many Phase III trials involve longer timescales. These changes, while encouraging, also make it apparent that it may be even more challenging to keep track of potential sites in China to involve in registration path clinical trials. Citeline’s new Chinatrove service is designed to keep track of these developments for you.

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