China set to become fourth IPEC region

By Phil Taylor

- Last updated on GMT

Related tags Pharmaceutical excipients council Active ingredient

China is on course to having its own version of the International
Pharmaceutical Excipients Council - joining its fellow
organisations in Europe, the Americas and Japan.

The creation of CPEC marks yet another step on the road for the Chinese pharmaceutical industry as it becomes a major power on the world market and seeks to align itself more closely with other regions from a regulatory perspective.

Just last month it was announced that the pharmacopoeias of the US and China will work more closely together to tighten up the physical and documentary standards applied to pharmaceutical ingredients and establish processes to update existing monographs in both countries.

And at a government level, China has already put the State Food and Drug Administration (SFDA) under the jurisdiction of the Ministry of Health, with the promise that the agency will exert greater authority over the pharmaceutical supply chain from raw materials to finished products.

That is a particularly pertinent point at present, given the controversy that has erupted over the contaminant OSCS (oversulphated chondroitin sulphate) seen in various heparin products around the world, as well as prior cases of contaminated glycerin originating from China and ending up in products as diverse as toothpaste, cough syrup and an antihistamine tablets.

There are also specific moves afoot with regard to excipients, with the SFDA aiming to implement a new set of regulations for excipients by the end of 2008.

An earlier attempt to draw up regulations in 2005 was widely criticised as it tried to treat excipients just like active pharmaceutical ingredients (APIs).

This would have required a level of supportive clinical and manufacturing data that simply does not exist for many excipients, which after all may be found in many other products apart from drugs.

The established IPEC groups - known as TriPEC - played a key role in convincing the SFDA that the excipient regulations on the table were flawed and gaining a reprieve until 2008 for their implementation, as well as a consultation process to make sure they do not present a major barrier for suppliers and drugmakers.

The creation of CPEC has to some extent arisen out of that effort, and should go a long way to solving some real problems for excipient suppliers seeking to supply China's fast-growing pharmaceutical industry, according to Dave Schoneker, chairman of IPEC Americas and director of global regulatory affairs at Colorcon.

The formation of the new group " will be instrumental in helping get regulation in China harmonised to worldwide standards ," commented Schoneker earlier this year.

He noted at the time that the SFDA visited a number of companies last year, including Colorcon and FMC, and was planning to continue that effort across the USA, Europe and Japan in 2008.

On 19 March, global branches of several IPEC member companies agreed in principle to become members of a future CPEC and to review a draft business plan that will be available to them for comment.

How the group will be organised remains under discussion but future meetings are planned.

At present, Nevin Cheng of Shanghai Coating Technology will be acting as general manager for ongoing organisational effort.

At the moment the embryonic organisation is operating out of the Beijing offices of the China Center for Pharmaceutical International Exchange (CCPIE), which is serving as the new group's secretariat.

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