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Health Canada issued guidance last month clarifying how the agency’s several centers will collect and manage information and material submitted by sponsors of prescription drugs. Read More
Doctors and researchers should have full access to clinical trial data on products licensed in the UK to ensure that the cost-benefits, as well as safety and efficacy, are considered in prescribing and coverage decisions, lawmakers say. Read More
French authorities in December fined Merck US $21.5 million for attempting to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More
While the number of patent settlements between brand and generic drugmakers has risen in the EU for the fifth straight year, the number of agreements leading to pay-for-delay deals has dropped significantly. Read More
The European Commission is looking for drugmakers to participate in pilots on early dialogue with health technology assessors, with the aim of better aligning new product development and HTA requirements. Read More
Foreign pharma can continue to invest directly in existing Indian drug companies, provided there is no “noncompete” clause in the transaction, the government says. Read More
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