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The EMA is planning to focus on 13 separate initiatives for 2017, ranging from fully implementing its priority medicines review pathway to boosting international cooperation. Read More
The European Medicines Agency Committee for Medicinal Products for Human Use recommended 11 medicines for approval, including four orphan drugs and three biosimilars. Read More
Less than a month shy of mandating electronic submissions of drug and biologic master files in the eCTD format, the FDA has decided to postpone the requirement until May 2018. Read More
The European Medicines Agency says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides — essential documents that are not listed as required in ICH Good Clinical Practice guidelines. Read More
India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C. Read More
The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications. Read More
Research heads of 19 global pharmaceutical companies signed on to an open letter calling for a quick decision to relocate the European Medicines Agency from London, post-Brexit — preferably at the June meeting of the European Council. Read More
Sponsors should include clear assessments of necessary future actions in their periodic safety update reports, not simply provide a list of adverse events, according to new guidance from the European Medicines Agency. Read More