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Australia’s Therapeutic Goods Administration is turning to the European Union for guidance as it seeks to adopt 10 guidelines — four new and six replacements — to improve the nation’s drug system. Read More
Health Canada has launched an online public database of information relating to drug company inspections, including which firms have a good history of meeting safety and quality standards and which do not. Read More
The European Medicines Agency is revising the way drugmakers conduct studies of drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. Read More
Drugmakers exporting drugs from India must now include barcodes on all tertiary and secondary packaging. The policy, intended to assure the safety and effectiveness of therapies reaching patients in the U.S. and elsewhere, affects drugs made on or after April 1, 2015. Read More
Drugmakers operating in New Zealand must begin creating safety signal management processes for every drug they distribute to satisfy the country’s drug regulators. Read More
Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says. Read More
A global regulatory group is following the EU’s lead in recommending that drugmakers use a risk-management approach to qualify and validate manufacturing processes. Read More
European regulators are looking to industry for suggestions on the best ways to get generic versions of topical drugs approved without having to conduct time-consuming and expensive clinical trials to prove bioequivalence. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
The European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug. Read More
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More