If you manufacture drugs in China — or you plan to — you need to master China’s new GMPs. China adopted updated GMP regulations in 2011 — effective immediately for new plants and no later than 2015 for existing facilities.
Some key differences between China and the US and EU:
The revisions also make significant changes from prior Chinese GMPs, including:
Only one guide aims specifically to help non-Chinese drug manufacturers get into compliance with China’s GMPs. By special arrangement, that guide is now available to FDAnews clients.
Based in Nanjing, Access China Management Consulting Ltd. specializes in helping foreign firms navigate the often-baffling Chinese drug market.
The new Chinese rules run 14 chapters and 313 articles. Latest Guide to Chinese Pharmaceutical GMP Regulations summarizes and explains them in an easy-to-understand digest covering all the provisions you need to be aware of.
China’s pharmaceutical market is projected to become the world’s second-largest in 2015. In 2015, where do you want to be? If you answered “China,” order your copies of Latest Guide to Chinese Pharmaceutical GMP Regulations now.
Latest Guide to Chinese Pharmaceutical GMP Regulations is available in pdf format only (7 chapters, 136pp.) for $750. Act now: place your order here.