Exclusive interview with IPEC China chairman Nevin Cheng

IPEC China’s chairman sets out next steps

By Gareth Macdonald

- Last updated on GMT

Related tags: Active ingredient

IPEC China must become a “harmonisation bridge between China and other countries,” according to Colorcon’s Nevin Cheng who was recently elected chairman of the new organisation.

The trade body, which joins sister groups in Europe, the Americas and Japan, has been set up to provide a voice for manufacturers, distributors and users of excipients in China.

Since its inauguration in Hong Kong in July, IPEC China officials have been working to establish the marketing and promotional infrastructure required to attract players in the country’s booming drug excipient sector.

Cheng told in-PharmaTechnologist.com, that the process will be long and must overcome many cultural hurdles. “Historically the excipient industry was paid much less attention… until a series of [well publicised] incidents relating to excipients [and the] supply chain. The whole society started to have increasing sense for how to ensure the safe application and use of excipients​," he said.

Cheng added that an IPEC survey, conducted in March last year at the International Control Strategy forum in China, revealed that over 80 per cent of the pharmaceutical industry attendees recognised the need for, and supported the establishment of, an independent industry association.

He explained that IPEC China’s must work to “promote mutual understanding and coordinate more opportunities for the Chinese government to learn how other countries [control] excipients, especially from regulatory and technical perspectives​.”

Cheng pointed out that a vital role of the new organisation would be to act as a communication platform between the excipient industry and the State Food and Drug Administration (SFDA), particularly with respect to any safety issues that emerge in the future.

Fully operational organisation

To date, IPEC China has brought multinational excipient manufacturers like Colorcon, FMC, Evonik, Dow Chemical and Pfizer into its fold but has, according to Cheng, received considerable interest from at least four China-based manufacturers.

Cheng commented that because “IPEC China is a very new organisation, it needs support from local industry and government [as well as] global sister associations​.”

In addition, IPEC China intends to develop its 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) to ensure that it fully covers all industries impacting on the excipient sector. The next step for IPEC will be to “develop a series of guidelines which will effect the new excipient regulations in China and push the compliance for industry-wide good manufacturing standard compliance (GMP),” ​concluded Cheng. The creation of the group comes at a time when the SFDA wants to exert greater authority over the pharmaceutical supply chain, from raw materials to finished products, and is aiming to develop a specific set of regulations for excipients by the end of the year, according to IPEC.

A 2005 attempt to develop a framework ran into opposition as it tried to regulate inactive ingredients in the same manner as active pharmaceutical ingredients (APIs). IPEC China’s sister organisations - IPEC Europe, IPEC Americas and JPEC in Japan (collectively known as TriPEC) - lobbied to get the SFDA to defer implementation until end-2008.

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