Thursday, April 03, 2008

US and Chinese pharmacopoeias expand working relationship

I would like to think that this will's hoping...

The pharmacopoeias of the US and China will work more closely together in future in a bid to improve the quality of medicines available in both countries.

To that end, the US Pharmacopoeial Convention and the Chinese Pharmacopoeia Commission have signed a memorandum of understanding (MoU), to tighten up the physical and documentary standards applied to pharmaceutical ingredients and establish processes to update existing monographs in both countries.

The deal is in response to the globalization of the pharmaceutical market, with drug firms increasingly sourcing ingredients from a wide range of territories.

Such a climate has created the need for greater cross-border collaboration on monitoring and standards. This was highlighted by recent problems with ingredients sourced in China that saw unscrupulous suppliers substitute the excipient glycerin for the toxic compound diethylene glycol (DEG). Since the case emerged, the USP has been working with the Food and Drug Administration's Pharmaceutical Ingredient Safety Taskforce to modify the identification test for glycerine, and to move DEG-specific testing from the impurity analysis section of the monograph to become part of the identity test.

link to full article

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