Regulatory Open Forum

My client wants to ship a few vials of their investigational drug product from the US to a potential licensing partner (consignee) in China.  The samples are for laboratory experiments only; they will not be administered to humans or animals. The World Courier representative in Beijing says that the consignee must obtain an import permit from the Chinese government for the samples to be allowed to pass through Customs.  The consignee seems to think that it will be very burdensome to obtain such an import license. Consequently, the shipment is not proceeding.

I have emphasized repeatedly that the samples will not be administered to humans or animals.  But the WC rep still thinks we need an import permit.

In 2014, I coordinated a shipment of the same drug product via World Courier to a different consignee in China, for animal tox experiments, with no particular difficulty.  Much more recently, my colleagues have shipped other chemical samples to China for lab experiments.  As far as I know, those shipments proceeded very smoothly.  i was unaware of any import permits being required.

Is the World Courier representative's assertion that we need an import permit correct?  If so, how should we proceed to obtain one?  If not, should we switch couriers with the hope of getting better advice?

Any insights will be greatly appreciated.

My client wants to ship a few vials of their investigational drug product from the US to a potential licensing partner (consignee) in China.  The samples are for laboratory experiments only; they will not be administered to humans or animals. The World Courier representative in Beijing says that the consignee must obtain an import permit from the Chinese government for the samples to be allowed to pass through Customs.  The consignee seems to think that it will be very burdensome to obtain such an import license. Consequently, the shipment is not proceeding.

I have emphasized repeatedly that the samples will not be administered to humans or animals.  But the WC rep still thinks we need an import permit.

In 2014, I coordinated a shipment of the same drug product via World Courier to a different consignee in China, for animal tox experiments, with no particular difficulty.  Much more recently, my colleagues have shipped other chemical samples to China for lab experiments.  As far as I know, those shipments proceeded very smoothly.  i was unaware of any import permits being required.

Is the World Courier representative's assertion that we need an import permit correct?  If so, how should we proceed to obtain one?  If not, should we switch couriers with the hope of getting better advice?

Any insights will be greatly appreciated.

I am having the same problem. Our investigational drug product is not a biologic. The consignee is not communicating what is required and it is still stuck in customs. This is for testing and not being sold, does it still require an import license?

My client wants to ship a few vials of their investigational drug product from the US to a potential licensing partner (consignee) in China.  The samples are for laboratory experiments only; they will not be administered to humans or animals. The World Courier representative in Beijing says that the consignee must obtain an import permit from the Chinese government for the samples to be allowed to pass through Customs.  The consignee seems to think that it will be very burdensome to obtain such an import license. Consequently, the shipment is not proceeding.

I have emphasized repeatedly that the samples will not be administered to humans or animals.  But the WC rep still thinks we need an import permit.

In 2014, I coordinated a shipment of the same drug product via World Courier to a different consignee in China, for animal tox experiments, with no particular difficulty.  Much more recently, my colleagues have shipped other chemical samples to China for lab experiments.  As far as I know, those shipments proceeded very smoothly.  i was unaware of any import permits being required.

Is the World Courier representative's assertion that we need an import permit correct?  If so, how should we proceed to obtain one?  If not, should we switch couriers with the hope of getting better advice?

Any insights will be greatly appreciated.