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The European Medicines Agency has issued guidance to help drugmakers improve their responses to scientific objections lodged by EMA review committees. Read More
Australian regulators are calling for labels on six types of nonsteroidal anti-inflammatory drugs to include strong warnings about cardiovascular and liver risks associated with excessive or prolonged use. Read More
Swiss and Chinese regulators plan to harmonize their regulations on market authorization and postmarket surveillance, with the aim of speeding access to new products in both markets. Read More
Three European industry groups are asking the European Commission to block an Italian law that encourages off-label drug use, saying it is driven entirely by economics at the expense of patient health. Read More
Five industry groups are jointly launching a new data center, the European Medicines Verification Organization, to help eliminate counterfeit drugs from the drug supply chain. Read More
The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them, setting up a test case for the EU’s new trial transparency policy. Read More
The UK BioIndustry Association and EuropaBio are calling for European regulators to drop plans to release Phase I clinical trial reports, saying the information they contain is commercially sensitive. Read More
Brazilian regulator Anvisa has set a 90-day timeline for reviewing requests to conduct clinical trials that are also being done in other countries. Read More
Mexican regulators laid out rules for older biosimilars registered prior to Oct. 19, 2011, when the country’s biosimilarity rules were first established, mandating that companies conduct clinical trials to prove biosimilarity. Read More
The proprietary name of a drug should include either the International Non-Proprietary Name or a description of its effects, and should be consistent across the product’s range, according to revised guidance from South Africa’s Medicines Control Council. Read More
India’s medicines authority has released a set of steps drugmakers must take to schedule presubmission screening meetings with drug reviewers — codifying an informal system that was launched several years ago. Read More
Australia’s research-based drug companies are urging the government to accept product approvals by trusted regulators in the U.S., EU, Canada and the UK with only minimal in-country review to speed access to breakthrough treatments. Read More