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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
Global drug regulators have reduced drug approval times over the last 10 years, and while the U.S. Food and Drug Administration remains the fastest at approving new drugs, other regulators are closing the gap. Read More
The White House released a joint statement by President Barack Obama and Indian Prime Minister Narenda Modi pledging to negotiate a harmonized approach to intellectual property protections and establish standard definitions for what is patentable. Read More
Manufacturers and industry groups are urging the Australian government to drop proposed requirements that would require larger type on drug labels and for labels to be made and applied in a way that prevents their being damaged when the product is opened. Read More
The European Medicines Agency has published a 100-page technical guide aimed at helping drugmakers comply with a new global standard on the reporting of individual case safety reports. The standard, ISO EN 27953-2, takes effect July 1. Read More
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. The official request, due 20 days later, should include the procedure number and a detailed justification for requesting the reexamination, according to updated guidance issued Jan. 22. Read More
Indian officials are accusing U.S. Food and Drug Administration investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for Indian regulators to tag along on FDA drug manufacturing inspections as observers. Read More
The U.S. Food and Drug Administration warned last month that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More