Many multinational trials will have a site in China, and the supply plan may be different compared to Europe or North America. A plan that has worked for other regions may not consider the documentation, import requirements, and transit times required for China. This will typically become apparent when the first shipment is due.

The objective of early planning is to understand which parts of the process will take time to complete before the product is required.

Why China Needs Its Own Supply Plan

Import requirements can vary between different markets. This could include documentation requirements, labelling, batch details and approvals. Sponsors should not assume the supply plan used in other regions will apply.

Transit times will increase due to the distance of travel. This will cause increased risk of products requiring controlled storage conditions. Even if the shipment arrives on time at the warehouse, there can be margin losses during transport. For more on this, read Hidden Blueprint Behind Faster Clinical Development: Aligning Comparator Sourcing, Licensing, & Manufacturing for Global Trial Success. 

Confirm Documentation Before Ordering

Start by creating a list of the documentation required for each shipment to China and who will be responsible for providing it. Confirm with the regulators and local partners what is required; specific labelling may be required or translations.

What part of the process is likely to take the longest? Often this will be an approval or review rather than the shipping. Once you know what part is going to take the longest, you can plan when to place your order with some realistic contingency.

Build Transit Time Into the Schedule

Plan transit time for the full route, from the source to the site. Include time for customs clearance and any local handling. Then add a margin, because a shipment that clears quickly in one month may take longer in another.

Temperature-sensitive products need particular attention. The packaging, carrier, and storage arrangements should be confirmed for the length of the route, not for an average trip.

Coordinate Local Partners and Sites

A China supply plan involves more parties than a single-country study: sponsors, sourcing teams, logistics providers, local partners, and site staff. Clear ownership helps prevent gaps. Each party should know what it is responsible for, what it needs from the others, and who to contact when something changes.

Time zones also affect communication. Agreeing on working hours and escalation routes in advance means a problem can be raised and answered within the same working day.

Keep Records Consistent

Shipments that arrive with inconsistent paperwork cause repeated checks and delays. A standard document pack, reviewed before each shipment, keeps the records the same from batch to batch. This also helps when a shipment is questioned or audited, because the history is easy to follow.

Plan for the Unexpected

Even a well-prepared shipment can be held. Decide in advance what happens in that case. Options can include using buffer stock already at the site, rescheduling a treatment visit, or shipping replacement product from an approved source. Each option must still meet the protocol and regulatory requirements, so the decision should be made before it is needed.

Start Early, Plan the Whole Route

Supply planning for China works best when it starts during protocol design. Identifying documentation requirements, transit times, and local responsibilities early gives sponsors room to adjust. Left until enrollment is underway, the same issues are much harder to fix.