Drug Safety: US and China

Although the safety of Chinese food exports to the US has garnered the most attention this year, drug safety has also been high on the agenda of both countries. The prominence of these issues culminated in the countries signing two memoranda of agreement on December 11: one focused on food safety (see page 11) and one targeting the safety of drug and medical devices.

The safety of drug and drug ingredients manufactured in China has long been an issue; numerous deaths have been linked to mislabeled, tainted or counterfeit domestic drugs. Recent US congressional hearings focused on the FDA’s lack of inspection of foreign drug manufacturing facilities that export drugs and drug products (see page 5). The new China-US agreement on drug safety specifies new requirements for both countries for the registration and certification of drug ingredient manufacturers, as well as new procedures for information sharing, notification of adverse events, determination of counterfeits and facility access. However, for now, the agreement only applies to certain drugs (see table) and medical devices.

Already this year, reform of China’s drug safety system has taken place. This summer, the country announced a five-year plan for food and drug safety, including increased inspections, enhanced monitoring procedures, new standards and the goal of increasing the percentage of drug samples tested from 30% to 80%. The country also disclosed plans to spend CNY 8.8 billion ($1.73 billion) over three to five years to improve its food and drug safety infrastructure (see IBO 8/15/07). New drug registration regulations that took effect in October specify tighter registration procedures, allow for greater transparency of drug approvals and enforcement actions, shorten the approval time for certain novel drugs and update the definition of drug types. To help align China’s drug manufacturing standards more closely with US and World Health Organization–approved standards, revisions to China’s GMP regulations will take effect on January 1, 2008.

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