Published in the Journal for Clinical Studies
￼China is a land of superlatives: the world’s second largest country by land area, with the largest population at 1.35 billion and growing. It is incredibly diverse, with 56 recognised distinct ethnic groups. Mountain ranges form a natural border to the West, the Gobi and Taklamakan deserts are in the North, and there are subtropical forests in the South. It has the Yangtze and Yellow Rivers, the third- and sixth-longest in the world.
More importantly for our purposes it has the world’s second-largest economy by both nominal total GDP and purchasing power parity. It is the world’s largest exporter and importer of goods. China spent approx 66.8 billion US dollars in 20111 just on pharmaceuticals.
China is not alone in requiring that any drug sold must have been tested in a clinical trial conducted in China. Pharmaceutical companies have little choice if they wish to market their drug once it is approved. Given that China makes up 19% of the world’s population, and is expected to overtake the US as the world’s largest market by 20202, there is no wonder that it is right at the top of the list of target countries. Currently 4648 trials are taking place there.3 There used to be a perception that it could take a couple of years to get approval to run a trial, but timelines have reduced dramatically. China is working towards a 90-day process, and typically it takes between three and six months. China benefits from a centralised healthcare system, and with such a huge population and regional centres of excellence there is a large patient pool accessible very quickly for many diseases in China. Recruitment can be swiftly completed.
When shipping takes place, probably the most important single document is the import permit issued by the BFDA (Beijing Food & Drug Administration). There are a lot of documents to be brought together in advance, which must be supplied to the BFDA for this to be issued. Once the permit is in place, arrangements should be made to import through Beijing rather than another port, in order to comply with all their requirements.
The documents required include a customs invoice, a copy of the draft airline paperwork (the MAWB), packing list, certificate of analysis, clinical trial approval which comes from the consignee, together with a copy of their business licence, and a first leg document showing the batch / lot number as indicated on the invoice. The customs invoice is very detailed, including the shipper’s and consignee’s name and address, what the contents are, shipment commodity description, country of origin, expiry date, batch number, manufacturer company name, and shipper company name, all of which need to be confirmed with the importer of record, and every single one of which must match the details on the inner packaging label on the packages. Any discrepancies lead to delays at customs and China Inspection and Quarantine. Every shipment has to be sent with a packing list and this is another place where attention to detail is imperative, otherwise things could go terribly wrong. The packing list needs some really specific information, including specifics on the content and the number of pieces, net weight and gross weight. Once the packaging has been decided on then it’s very difficult to make changes. Customs are expecting these exact details, and if anything is different when it arrives then they won’t let the shipment go through without further inspection. This may lead to a new import permit needing to be issued, during which time the clock is ticking, the shipment is waiting at the airport, and there is the potential for it to be moved into storage at the wrong temperature, or even damaged!
In Beijing it takes around two days to clear customs, or longer if the shipment is selected for inspection. Storage facilities at the airport need to be booked in advance, and documentation provided for the need for temperature- controlled storage. Temperature-controlled shipments selected for customs inspection will be taken out of the temperature-controlled area into an uncontrolled ambient area until inspection, which takes 24-48 hours. Packing the shipment carefully so that it can withstand this temperature challenge, which could be several days after leaving the origination point, will almost certainly need a box using PCMs to control temperature. The consignee also needs to provide letters of instruction for customs purposes and quarantine purposes, their 10-digit registration code for both customs and CIQ, and an authorisation letter for the transport company to collect from the airline. It is clear that China can be challenging, but systematic processes lead to success, a minimum of delays, and ultimately access into this vast marketplace.
“The spirited horse, which will try to win the race of its own accord, will run even faster if encouraged,” wrote Ovid, the Roman poet, and in this the Chinese year of the horse we should all be encouraged to embrace China and include it in our global plans.
1. International Federation of Pharmaceutical Manufacturers & Associations
2. IMS Health, 2011
3. http://www.clinicaltrials.gov/ct2/search/map/ click?map.x=607&map.y=187