Reply To: Regulatory release of IMP
June 28, 2021 at 8:04 amIf your supply chain initiates in the EU for US use then a QP release will happen before the QA release but that QP release should only be a GMP review and should not require any regulatory aspects (assuming the material is not being used in the EU). I have seen several opinions on when US import can be initiated. Most companies wait until 30 days post IND application. That is the least risky as it ensures there are no questions/concerns from the FDA. I have seen companies import as soon as the IND is filed but that carries a little risk of delay. I do not recommend trying to import before an IND has been filed as this is the surest way to have your shipment delayed if not rejected.
