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The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable drugs, but questions remain about the program’s transparency and how the market would be divided among competing partnerships. Read More
Foreign companies seeking to market novel drugs in China should have an easier time, thanks to an agreement by Chinese officials to cut regulatory red tape. Read More
Overly zealous national and local healthcare funding schemes have put the UK far behind other industrialized countries in providing patients access to the latest drug therapies, an industry report concludes. Read More
Last year saw major strides in increasing transparency around clinical trial data in the EU and trial safety and compensation in India. An international group also set the gears in motion for a harmonized guideline on multiregional clinical studies.Read More
The FDA plans to consolidate its 16 districts overseeing pharmaceutical imports into just four or five under a reorganization plan designed to make inspection policies and procedures more uniform across all ports of entry. Read More
Drugmakers can now access all regulatory advice on regenerative medicines in the UK through a single web portal, thanks to a government initiative launched Oct. 13. Read More
The Australian government plans fast-track approvals and joint drug reviews with other countries, following an independent review aimed at making the drug approval process less redundant and easier to understand. Read More
Australia’s medicines authority is urging tougher warnings on the cardiovascular risks of over-the-counter nonsteroidal anti-inflammatory drugs, as well as new initiatives to inform patients about the risks associated with both OTC and prescription versions of the painkillers. Read More
Health Canada wants sponsors of cell therapy products to conduct preclinical studies either in vitro or in animals to address potential risks and delivery issues before initiating human trials of the products. Read More