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European drugmakers can expect a more globalized European Medicines Agency, according to the regulator’s 2014 work program, which includes an increase in joint inspections with international counterparts, improving the agency’s support for companies in early-stage drug development and completing the rollout of the massive new pharmacovigilance requirements begun in 2012. Read More
The European Medicines Agency (EMA) has launched a new pilot program intended to speed new therapies to patients via a process that authorizes products for use by targeted populations in stages. Read More
India will no longer allow the importation of drugs that have used up more than 40 percent of their shelf life, the Central Drugs Standard Control Organization said Feb. 13. Read More
India’s Ministry of Health and Family Welfare has begun publishing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial. Read More
Sponsors may be asked to provide the European Medicines Agency with additional data from failed trials to hone in on subpopulations where the treatment may be effective. Read More
PhRMA has asked the Office of the U.S. Trade Representative to put the EU on notice for its plan to publish clinical trial data that currently is treated confidentially. Read More
Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format only, allowing for cost savings and potentially swifter reviews. Read More
Sponsors seeking marketing authorization for new drugs in the EU must now apply for a numerical code unique to the submission, the European Medicines Agency says. Read More
The UK’s Medicines and Healthcare products Regulatory Agency recorded a nearly 20 percent increase in complaints about drug advertisements in 2013 — the majority coming from companies complaining about their competitors. Read More
U.S. Food and Drug Administration Commissioner Margaret Hamburg said her 10-day trip to India succeeded in syncing U.S.-India views on quality of medical products. Read More
Drugmakers should test porcine trypsin, a starting material used in biologic drugs, just after it is produced to ensure material from a single infected pig doesn’t enter production batches, the European Medicines Agency says. Read More
The U.S. Food and Drug Administration and European Medicines Agency have launched a new information-sharing initiative aimed at speeding international responses to drug safety problems. Read More