CASE STUDY : EU BATCH CERTIFICATION OF A BIOLOGICAL PRODUCT MANUFACTURED IN CHINA FOR USE IN A EUROPEAN CLINICAL TRIAL European regulations require that a qualified person (QP) to certify that every investigational medicinal product (IMP) entering the EU has been manufactured in accordance with all applicable laws and regulations. This case study outlines how CSM helped one sponsor’s contract manufacturing organization (CMO), located in China, import a biological product for use in a clinical trial in the EU. This was the first time the CMO had sent IMPs to the EU, so it required an especially high level of guidance to be sure the CMO complied with all required standards. EU Release and the Importation of IMPs in the European Union EU regulations require the QP to issue a bat

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