Excipient Control Strategies in China - Pharmaceutical Technology

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Excipient Control Strategies in China
As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.


CPhI Focus: Pharmaceutical Ingredients


The ongoing collaboration of industry groups such as IPEC with SFDA and FDA will effectively provide appropriate excipient controls that benefit the consumer by improving drug safety and quality. This collaboration and dialogue will also ensure that new regulatory requirements are reasonable and do not create non-value-added costs in the system that would unnecessarily increase drug prices without providing any further improvements in safety to the consumer.

David R. Schoneker is chairman of the International Pharmaceutical Excipients Council of the Americas. He also is director of global regulatory affairs at Colorcon, 1936 West Point Pike, West Point, PA 19486, tel. 215.699.7733,
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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Source: CPhI Focus: Pharmaceutical Ingredients,
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