China State FDA Includes Drug GMPs In Expected 2010 Reforms
This article was originally published in The Tan Sheet
Executive Summary
China's State FDA insists it will align the country's pharmaceutical and medical device regulations with international standards. The question manufacturers have is, how soon
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China revises GMPs
China's State Food and Drug Administration proposes revised good manufacturing practices that would give nonprescription drug firms three years to implement changes once guidelines are issued. Guo Jingwu, director of drug safety in SFDA's Inspection Department, said June 2 at a conference in Shanghai that SFDA adopted the guidelines May 28 and expects to issue the document in June. China's Ministry Of Health is reviewing the guidance and will submit it to the World Trade Organization before releasing it. SFDA will give companies three years to implement changes, though firms that manufacture injection drugs and products on China's Essential Drug List will have two years. The GMP revision, a key goal for SFDA in 2010, is part of the agency's work to align China's pharmaceutical and medical device regulations with international standards (1"The Tan Sheet" March 8, 2010)
China revises GMPs
China's State Food and Drug Administration proposes revised good manufacturing practices that would give nonprescription drug firms three years to implement changes once guidelines are issued. Guo Jingwu, director of drug safety in SFDA's Inspection Department, said June 2 at a conference in Shanghai that SFDA adopted the guidelines May 28 and expects to issue the document in June. China's Ministry Of Health is reviewing the guidance and will submit it to the World Trade Organization before releasing it. SFDA will give companies three years to implement changes, though firms that manufacture injection drugs and products on China's Essential Drug List will have two years. The GMP revision, a key goal for SFDA in 2010, is part of the agency's work to align China's pharmaceutical and medical device regulations with international standards (1"The Tan Sheet" March 8, 2010)
China revises GMPs
China's State Food and Drug Administration proposes revised good manufacturing practices that would give nonprescription drug firms three years to implement changes once guidelines are issued. Guo Jingwu, director of drug safety in SFDA's Inspection Department, said June 2 at a conference in Shanghai that SFDA adopted the guidelines May 28 and expects to issue the document in June. China's Ministry Of Health is reviewing the guidance and will submit it to the World Trade Organization before releasing it. SFDA will give companies three years to implement changes, though firms that manufacture injection drugs and products on China's Essential Drug List will have two years. The GMP revision, a key goal for SFDA in 2010, is part of the agency's work to align China's pharmaceutical and medical device regulations with international standards (1"The Tan Sheet" March 8, 2010)