There are many advantages to conducting clinical trials in China today. China boasts a huge market, a massive patient pool, rapid patient recruitment capabilities, low laboratory and technical costs, and a large number of highly-trained researchers and scientists. At the same time, however, the industry faces a number of challenges in China including its complex and often daunting regulatory/importation process.
Clinical Trial Approval
China’s Regulatory & Import Environment
As most bio-practitioners would likely agree, one of the largest hurdles to overcome has been the lengthy and complex clinical trial approval (CTA) process which can take six to 12 months after all documents have been submitted to the State Food and Drug Administration (SFDA).
Once approval has been received, customs and importation present another enormous challenge when doing business in China as, under the “per shipment permit” process, each shipment arriving in China requires an individual permit.
Required documentation for the Beijing FDA (BFDA) permit includes:
- SFDA clinical trial approval (CTA)
- Certificate of Analysis (CoA)
- commercial invoice
- a copy of the airway bill (AWB)
- if the country of origin/manufacture appearing on the CoA is not the same as the shipping country, an AWB and commercial invoice for transit from country of origin/manufacture to shipping country must also be provided
- a copy of the consignee’s business license
- POA/authorization for BFDA permit application – completed by the sponsor, CRO or affiliate office in China
Required documentation for customs clearance includes:
- BFDA permit
- letter of instruction for customs purposes
- letter of instruction for quarantine purposes
- letter of instruction to airline ground handler
- 10-digit customs registration code
- 10-digit China Inspection and Quality (CIQ) registration code
Clearly, “per shipment permit” importation can be a costly, troublesome and can draw considerably on resources.
Drug Supply Chain Solutions
One potential solution to counter this cost- and labour-intensive importation process is to consolidate smaller international shipments into larger batch shipments. By utilising a local depot within China for domestic distribution, the number of importations and import permits required can be significantly reduced.
The following case study illustrates this strategy:
A multinational pharmaceutical company is planning a Phase III diabetes study in China. The duration of the study is 12 months. Eight sites will participate. Temperature range of the investigational drugs is between +2oC and +8oC.
The sponsor is considering two options:
- The first is a “direct-to-site” solution in which two 10kg shipments are shipped monthly to each site on a fixed schedule. In all, a total of 192 international shipments (2 shipmentsx8 sites x12 months) are dispatched.
- The second option is to utilize the services of a China in-country depot in Beijing. Instead of coordinating 192 small international shipments individually, the sponsor would consolidate the contents into four larger batch shipments destined for the Beijing depot on a quarterly basis. Here they would be stored in a refrigerated facility and shipped out as required under a flexible “just-in-time” domestic distribution schedule.
China In-Country Distribution
After considering the advantages of each scenario, the sponsor chooses the second (China in-country distribution) solution. Benefits are significant including:
- savings of 23% in transportation costs over the direct-to-site solution
- a reduction of import permit applications from 192 to just four
- reduced transit and turnover time
- reduced paperwork
- improved communications between the sponsor and local site personnel, using the depot’s bilingual pharmacists/logistics personnel to channel key information
Selection criteria for investigational drug depots
What are some of the criteria for selecting a local depot?
- First, consideration should be made of the depot location. In China, Beijing is an ideal location as the SFDA is situated here. A concentration of flights from Beijing also assures prompt distribution.
- Secondly, the depot facility must conform to the needs of the researchers. The depot should be secure, controlled and GMP-compliant. Storage areas should provide for a variety of potential temperature requirements including controlled ambient (15ºC to 25ºC), cold chamber (2ºC to 8ºC) and freezers (-20ºC/-26ºC).
- To ensure confidentiality, the drugs should be stored in separate lockers by protocol number.
- Online inventory management is an important consideration as is the capability of depot personnel to mange drug distribution and return.
For more information, or for assistance with a BFDA permit or customs clearance, please contact World Courier’s Beijing office at + 86 10 8497 1841.