China to Raise Access Threshold for Pharmaceutical Excipients

China published regulations on pharmaceutical excipients supervision to realize full supervision of the pharmaceutical production and supply chain since 1 February 2013.

 

On 2 August 2012, China’s State Food and Drug Administration (SFDA) issued the Regulation on Strengthening Pharmaceutical Excipients Supervision in a press conference (hereinafter referred to as the “Regulation”), which will come into effect since 1 February 2013. Under the Regulation, the respective duties and obligations of pharmaceutical manufacturers and excipient manufacturers are specified accordingly. The pharmaceutical manufacturers will take the primary responsibility for illegal use of excipients in producing drugs and should assure the quality of excipients purchased from their excipient suppliers. So pharmaceutical manufacturers are required to fortify the quality management system and sign quality agreement with the main suppliers in the Regulation. The pharmaceutical excipient manufacturers should strictly comply with the Good Manufacturing Practice (GMP) for Pharmaceutical Excipients in the process of production, while which being effective since 2006 is only taken as a voluntary standard before the issue of the Regulation.

Aug. 10th, 2012