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IPQ Inside the global regulatory dialogue

China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India Among Countries Reviewing Excipient Regulatory Upgrades

May 27th, 2014

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China is among countries giving consideration to establishing a drug master file (DMF) system for excipients, as regulators world-wide seek to rationalize and improve their approaches to excipient oversight.

Interest in an excipient DMF system was expressed by China’s FDA (CFDA) at meetings in late April with the International Pharmaceutical Excipients Council (IPEC) China and the U.S.-China Joint Commission on Commerce and Trade (JCCT).

IPEC China is planning to sponsor a workshop for CFDA on excipient DMFs in late 2014 or early 2015 that would include participation of the U.S. FDA.

The story continues for subscribers beginning on page 2, and includes a discussion of the situation in India, which speaks to the vagaries that the pharmaceutical community faces in excipient regulation around the world.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

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