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SFDA implements a special review procedure for bird flu drugs
11/14/2005
The State Food and Drug Administration (SFDA) issued on November 7, 2005 an emergent notice, which required a special procedure of reviewing bird flu drugs and medical devices to be established. The notice also required stronger drug market regulation, cracking down on false advertisements and promotions related to the prevention and treatment of highly contagious bird flu and maintaining market order.
To assist technological breakthroughs in bird flu prevention and control and speed up the research and development of human bird flu drugs and devices, SFDA requires that relevant laws, regulations and procedures be implemented to ensure scientific and fair review and high-quality, high-efficient and timely work of acceptance, review and approval. As to important applications, timely knowledge of scientific research trends and pre-intervention are needed. As to drugs and medical devices that need to be imported, food and drug administrations and testing institutions should work with the Customs to speed up testing, approval and clearance.
SFDA required local food and drug administrations to strengthen the supervision of drug and medical device markets. A comprehensive supervision and inspection of manufacturing and distributing of drugs and medical devices related to highly contagious bird flu should be conducted. The supervision of drug and medical device distribution in the jurisdiction of each food and drug administration should be strengthened. Crimes related to counterfeit drugs and medical devices should be firmly cracked down. Any false advertisements and promotions related to the prevention and treatment of highly contagious bird flu should be firmly punished. Market order and safe drug use should all be guaranteed.
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