We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A public-private partnership in the EU plans to spend $4.5 billion over the next decade to boost, by 30 percent, the success of clinical trials on high-priority drugs. Read More
European authorities say there is not enough evidence to conclude that emergency contraceptives lose their effectiveness in women weighing 165 pounds or more, as one manufacturer had cautioned in its product labeling. Read More
The French National Assembly last month approved a proposal that would allow doctors to use less expensive off-label drugs even if an approved therapy exists — sparking cries from European drugmakers that the government is placing cost savings over patient safety. Read More
Pharma is seeking greater clarity around a European Medicines Agency initiative to streamline regulatory approvals of drugs and national coverage decisions via parallel reviews by the EMA and health technology assessment bodies. Read More
Drugmakers are praising a decision by Ireland’s Health Products Regulatory Authority to allow as many as three dozen drugs to be sold through pharmacies without a prescription. Read More
The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says. Read More
Australia’s Therapeutic Goods Administration is now following Europe’s lead on drug safety oversight in both general and pediatric populations. Read More
Two years after the EU implemented landmark pharmacovigilance legislation, the European Medicines Agency is offering drugmakers and other interested parties a comprehensive look at how the region’s drug safety system actually operates. Read More
Manufacturers of nonprescription drugs sold in Australia have until Dec. 20 to include statements on specific risks in the product labeling, according to the Therapeutic Goods Administration. Read More
The UK’s healthcare costs watchdog is overhauling its recommendations for management of stroke risk in patients with atrial fibrillation, recommending that doctors prescribe three new generation anticoagulants rather than commonly used warfarin or aspirin. Read More
A loophole in the oversight of active pharmaceutical ingredients and an inconsistent reporting structure are just some of the challenges the U.S. Food and Drug Administration faces in improving drug quality in China, according to the agency’s top official there. Read More