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US and Chinese pharmacopoeias expand working relationship

By Gareth Macdonald , 03-Apr-2008

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. The USP/ChP move echoes efforts by other regulators in the industry to improve standards and increase international collaboration. Last month for example, the FDA announced plans to increase its presence in China in an attempt to expand its monitoring capability.


Improved third party verification Under the terms of the new MoU agreement, representatives from the USP and the ChP will explore ways to improve the third party verification of ingredients for import and export in both countries. Additionally, the two agencies will collaborate on both expediting the translation of the USP compendia and on assessing the quality of the English translation of the Chinese equivalent. To facilitate the collaboration, the USP and the ChP said that they intend to hold a scientific symposium twice a year and will put in place an exchange program to allow their respective scientific staff to work overseas.


Roger Williams, USP executive vice president, commented that: "this agreement represents our combined commitment to improving patient care and advancing public health in the US and China through rigorous quality standards for medicines." Harmonization While the goal of such collaborations would undoubtedly improve the quality of drugs available worldwide, some observers fear that building closer ties with ChP could exacerbate ongoing difficulties in bringing the US, European and Japanese pharmacopoeias into alignment Speaking at the International Pharmaceutical Excipients Council (IPEC) Europe annual seminar in late January, Janeen Skutnik, director of regulatory monitoring at Pfizer said that maybe a ground-up, collaborative approach that allowed the development of novel monographs was needed.


Skutnik also proposed a more radical approach involving mutual acceptance of standards between the pharmacopoeias. She explained that: "this could come about if it were to be accepted that the three main pharmacopoeias all have valid processes, and that monographs from any of the three could be cited and accepted without additional filings, variations or validation."

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