[Anonymous]

Reply To: Minimum Shelf Life Requirements for Importation to Asia-Pac

China will allow chemical entities to be imported under 12 months but typically must have at least 6 months of expiry left at time of entry. However, we have recent experience with an import accepted with under 6 months. If under 12 months of stability remaining at time of import, the Sponsor or CRO must provide an Explanation letter be submitted to the SFDA with rationale. It will need translated, submitted and approved before moving forward with shipment. This typically will take 30 days to be approved.