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FDAnews Device Daily Bulletin
June 26, 2012 | Vol. 9 No. 125
GMP Compliance Rules Expected as Part of Chinese Regulatory Update
China is expected to begin amending its current medical device rules this year, as part of its 12th five-year plan to update its drug and device regulations, according to a panel of China experts at the Food and Drug Law Institute’s annual conference in Washington, D.C. Near the forefront of the anticipated revisions are new GMP compliance rules, said Chen Yang, a partner at Sidley Austin. The regulations represent a “huge task” for the Chinese government, at a time when it is also discouraging the creation of new manufacturing facilities, she said.
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