RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Making Sense of FAERS: Researchers Suggest Fixes to FDA's Adverse Event Database

    A team of researchers from Novartis, Oracle Health Sciences and the University of California, San Francisco say the US Food and Drug Administration's (FDA) adverse drug reaction database could be improved by grouping drugs by their chemical structure and automating certain reporting functions. In a paper appearing in eLife earlier this month, the researchers say such changes could help address several major challenges to interpreting data in FDA's adverse event reporti...
  • Regulatory NewsRegulatory News

    Plain Language Labeling Regulations to Take Effect in Canada

    Health Canada has released a new guidance document intended to clarify new "plain language" labeling requirements before new regulations take effect on 13 June 2015. Background In 2013, Canada's then-Minister of Health Leona Aglukkaq announced the government was launching a new initiative toimprove drug safety by making product information easier to understand for consumers. Making labels and packaging easier to understand, Aglukkaq said, would "help prevent advers...
  • China: SFDA Issues New PSUR Guidance

    New guidance on submitting periodic safety update reports (PSURs) for drugs was released by China's State Food and Drug Administration (SFDA) on 6 September.  The guidance conforms to the harmonized PSUR standards developed by the International Conference on Harmonization [ICH E2C (R1)].  Foreign importers and joint ventures must submit Line Listings, summary tables (Summary Tabulations) and the company's core data table (Company Core Data Sheet, CCDS) transla...