China SFDA Creates New Regulatory Pathways for Transfer of Drug Licenses


To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for technology transfer, which implies new avenues for the transfer of drug product licenses.

The Technology Transfer Rules issued by the SFDA in 2009 (the “Transfer Rules”) permit the transfer of pharmaceutical manufacturing technology in two cases: i) where the transferor and the transferee are affiliates or ii) where the transferor has an import license for the product and the transferee applies to manufacture the product locally based on the transferor’s technology. The provincial FDA, where the transferee is located, is the appropriate authority to receive an application for technology transfer, but the technical review is performed by the Center for Drug Evaluation (“CDE”) under SFDA. After the technology transfer is approved by the SFDA, the transferee will obtain the product license in its name for the product manufactured in reliance on the transferor’s technology.

The Notice introduced two key changes to the Transfer Rules to the extent that the product in question is not a biological product. The technology transfer involving biological products must comply with the 2009 Transfer Rules.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.