ICH sends Q11 regs to EMA, FDA and MHLW By Gareth MAcdonald 21-Dec-2012 - Last updated on 21-Dec-2012 at 15:07 GMT Facebook Twitter Linkedin Email to a friend May saw the ICH share its Q11 guidelines on API manufacturing with regulators in Europe, the US and Japan. EC discusses ‘equivalence assessments’ for APIs shipped to EU Quality regulations lag behind modern understanding; FDA GSK commits £500m to UK biomanufacturing plant China chromium crackdown ICH sends Q11 regs to EMA, FDA and MHLW India publishes similar biologics guidelines US FDA safety and innovation Act becomes law WADA discusses drugmakers' role in catching Olympic cheats GM camels for drug production Flight to Quality is cause of fine chem optimism Obama re-elected MHRA concerned about inspection burden under EU import laws Prev 1 … 3 4 5 6 7 … 12 Next
