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.
An advisory panel to India’s Central Drugs Standard Control Organization is calling for guidelines on the verification of fixed-dose combination drug products that are currently being sold without marketing authorization. Read More
In the wake of a rash of infant deaths related to GMP-certified hepatitis B vaccines, China is renewing its push to have makers of vaccines, blood products and sterile injectables obtain a revised good manufacturing practice certificate. Read More
The World Health Organization and advocacy groups from around the world are calling on drug regulators to ease “excessive regulatory restrictions” on opioid painkillers, saying they leave millions of cancer patients without effective pain management. Read More
To discourage GMP scofflaws, the European Medicines Agency is now publicly naming drugmakers that aren’t in line with current good manufacturing practices. Read More
Beginning March 1, China’s National Health and Family Planning Commission will publish a blacklist of drugmakers accused by provincial officials of offering bribes to customers. Read More
Transparency and bribery — ying and yang — all but dominated global pharmaceutical headlines in 2013. “Sunshine” was cast on regulatory authorities and drugmakers in the U.S. and European Union. A number of industry associations and some individual companies also took steps to operate more transparently. The moves came as a major bribery scandal made waves in China, bringing pressure for more punishing antibribery rules. Meanwhile, the EU and India pushed forward with new clinical trial controls, and U.S. track-and-trace efforts advanced. With 2014’s script still a work in progress, take a look back at 2013 and use its lessons to plan your business strategy for the coming year.Read More
Drugmakers that market products in Brazil have two years to present Anvisa with a full report of traceability of at least three batches, according to a resolution published in the Dec. 11 Official Journal. Read More
EU lawmakers last month approved a compromise proposal for a new clinical trials regulation, paving the way for a March 10 plenary debate and adoption of a single regulatory framework for all 28 member states before upcoming May elections. Read More
Merck’s blood thinner vorapaxar appears headed for the regulatory finish line after years of clinical hiccups, securing a 10-1 vote in favor of approval from an FDA advisory panel Wednesday. Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Tuesday, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More