International Pharmaceutical Excipients Council (IPEC) is in the middle of setting up a China Excipients Working Group, according to a report on  PharmAsia News quoting The Gold Sheet.

"We are very close to having a good concept for how that can work and help support improved controls in China, which is something we all want,” said IPEC Americas Chair David Schoneker, who is also director of global regulatory affairs at Colorcon, at the IPEC Americas Regulatory Affairs Conference in September.

The China working group initiative stems from a growing working relationship between the International Pharmaceutical Excipients Council and China’s State Food and Drug Administration, according to Schoneker.

SFDA drafted some excipient regulations in 2005 that treated excipients like APIs, requiring clinical study data, drug master file data, GMP certificates, “all kinds of things that don’t even exist in some cases, so there was a major problem that developed.”

In response, IPEC Americas, IPEC Europe and JPEC in Japan formed a coalition to contest the new excipient regulations with other industry groups including PhRMA, GPA, EFPMA and RDPAC. Working with the U.S. Commerce Dept., the coalition presented its concerns at a Joint Commission of Commerce and Trade meeting in 2006, “and we were very successful in convincing the SFDA that they really hadn’t got it right.” 

Schoneker said the coalition emphasized that “we fully supported increasing some of the controls in China, but it had to be done in a way that was workable, and we wanted to work with them and help provide supporting information to help them develop it in the right way.”

Consequently, SFDA decided to delay implement­tation of the new regulation until 2008 “so that they could learn more about how excipients are controlled internationally."

IPEC then collaborated with SFDA to organize a March 2007 conference in Beijing on international excipient control strategies, which drew 150 makers and users of excipients from around the world, 30 key SFDA officials, the heads of all three major pharmacopeia, “and there was a really great exchange of information.”