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IPEC China Gives Voice To Excipient Industry
- Publisher：
- Publication：2009/12/11
Excipients, the inactive substances that stabilize and help deliver the active ingredients in pharmaceuticals, now has a champion in China: the International Pharmaceutical Excipients Council (IPEC) China. The new organization, made up of members of the China excipient industry, join similar organizations called IPEC Americas, IPEC Europe and JPEC in Japan. The group represents manufacturers, distributors and users of excipients. IPEC China expects to work with the SFDA in establishing standards for excipients.
IPEC China was formed in July in Hong Kong. It will serve as a ¡°harmonization bridge¡± between China and other countries, according to Nevin Chung, who was elected chairman of the group and works for the international excipient company Colorcon. Colorcon, which is based in the US, has facilities throughout the world, including Asia. In China, Colorcon is located in Shanghai.
In 2005, the SFDA proposed a draft of regulations that treated excipients much like APIs, requiring clinical study data, drug master file data and GMP certificates. These regulations were much more rigorous than prevails in the rest of the world. Predictably, excipient manufacturers protested loudly. The SFDA backed off their proposals and put off establishing any new rules until 2008 ¨C which is now almost over. Even though there isn¡¯t much time remaining in the year, IPEC China still hopes to have a set of regulations in place by the end of 2008.
IPEC China is in favor of regulation, though it would like a set of rules that is closer to international standards. The organization is developing a series of guidelines that will help form new excipient regulations. It will also seek to require compliance with industry-wide good manufacturing procedures.
So far, IPEC China counts as members several multinational excipient manufacturers such as Colorcon, FMC (NYSE: FMC), Evonik, Dow Chemical (NYSE: DOW) and Pfizer (NYSE: PFE). The organization says it has received indications of interest from at least four China-based manufacturers.
Also, IPEC China is strengthening ties with the SFDA, the Chinese Pharmacopoeia and anti-counterfeiting body the National Institute for the Control of Pharmaceutical and Biological Products of China (NICPBP).
IPEC China was formed in July in Hong Kong. It will serve as a ¡°harmonization bridge¡± between China and other countries, according to Nevin Chung, who was elected chairman of the group and works for the international excipient company Colorcon. Colorcon, which is based in the US, has facilities throughout the world, including Asia. In China, Colorcon is located in Shanghai.
In 2005, the SFDA proposed a draft of regulations that treated excipients much like APIs, requiring clinical study data, drug master file data and GMP certificates. These regulations were much more rigorous than prevails in the rest of the world. Predictably, excipient manufacturers protested loudly. The SFDA backed off their proposals and put off establishing any new rules until 2008 ¨C which is now almost over. Even though there isn¡¯t much time remaining in the year, IPEC China still hopes to have a set of regulations in place by the end of 2008.
IPEC China is in favor of regulation, though it would like a set of rules that is closer to international standards. The organization is developing a series of guidelines that will help form new excipient regulations. It will also seek to require compliance with industry-wide good manufacturing procedures.
So far, IPEC China counts as members several multinational excipient manufacturers such as Colorcon, FMC (NYSE: FMC), Evonik, Dow Chemical (NYSE: DOW) and Pfizer (NYSE: PFE). The organization says it has received indications of interest from at least four China-based manufacturers.
Also, IPEC China is strengthening ties with the SFDA, the Chinese Pharmacopoeia and anti-counterfeiting body the National Institute for the Control of Pharmaceutical and Biological Products of China (NICPBP).
Source: Web of IPEC