Simplifying Global Compliance
Drug companies could pay as much as US $330,000 per authorized product to cover postmarketing assessments required by the EU’s new pharmacovigilance law, under fees proposed by European lawmakers. Read More
The European Medicines Agency is advising drugmakers to create a separate program to assess the effectiveness of risk-minimization efforts for each marketed drug. 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
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
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
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
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
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
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
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
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
Manufacturers of stem cell and cell-based products (SCCPs) should perform stability tests during early phases of clinical trials to establish the products are sufficiently stable for the period required by the study, a draft guidance by India’s Central Drugs Standard Control Organization advises. 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
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