China SFDA Streamlines Approval Process For AIDS, Cancer Drug Imports (China)
This article was originally published in PharmAsia News
Executive Summary
China's State FDA says it is taking steps to remove some of the country's barriers to importation of cancer drugs, and of HIV/AIDS drugs in the wake of new infection figures. Drug registration Director Zhang Wei said the SFDA has adopted a streamlined approach to approving imports of drugs in the two categories, if they demonstrate significant clinical effects in treating disease. Under the policy, the agency cuts its 150 working days for approving most drugs to just 120 for an AIDS drug. Zhang also said U.S. company Gilead's Viread (tenofovir disoproxil fumarate) second-line anti-retroviral drug cocktail is under review. (Click here for more