Beyond Compliance: New Chinese Pharmaceutical Excipient Regulation is No Substitute for Taking Common Sense Steps to Protect Supply Chain (Part Two)
This is the second in a two-part analysis on China’s new Pharmaceutical Excipient Measures. Part One is available here. On February 5, 2013, SFDA circulated for comment the first batch of 28 excipients that are subject to registration. This list covers gel capsules as well as excipients used in sterile injectable formulations — those derived […]
China’s New Pharmaceutical Excipient Regulation Stresses Responsibility for Quality Assurance, Supply Chain Management (Part One)
This is the first of a two-part analysis on China’s new Pharmaceutical Excipient Measures. Part Two is available here. On February 1, 2013, China’s “Measures to Strengthen the Supervision of Pharmaceutical Excipients” (Notice No. 212, 2012) (“Pharmaceutical Excipient Measures” or the “Measure”) came into force. This Measure was issued by the State Food and Drug […]
China’s Ministry of Environmental Protection (MEP) Releases Regular Reporting Requirements for Four New Substances
China: On January 4, 2013, China’s Ministry of Environmental Protection (MEP) released regular reporting requirements for four new substances under its chemical registration regime. Two of the newly certified compounds are classified as hazardous and the other two as dangerous. Under China’s new chemical registration regime, the “Provisions on the Environmental Administration of New Chemical […]