More Severe Punishment for Non-Compliance of the Revised HC Registration Measures

SAWS to Enforce More Severe Punishment for Non-Compliance of the Revised HC Registration Measures

 

August 23, 2012

 

The recently released “Measures for the Administration of Registration of Hazardous Chemicals” (SAWS Order 53) has just come into force in China on Aug 1st, 2012. Besides the attention-grabbing changes in the regulated scope (“Catalogue of hazardous chemicals in China”), legal entity (both manufacturers and importers are included for registration) and registration contents, SAWS will impose more severe punishment on those who do not comply with this newly released Measures.

Aug. 23rd, 2012






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