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  • EMA Opens Consultation on Proposed Pediatric Development Framework

    The European Medicines Agency (EMA) is opening a public consultation on a newly released report in which it calls for a new framework to incorporate the views of children into the review of clinical trial plans before the Pediatric Committee (PDCO). The report, " Concept paper on the involvement of children and young people at the PDCO ," is aimed at meeting the requirements of the Charter of Fundamental Rights of the EU, which states that member states should take into ...
  • EMA Opens Consultation on Product Information Changes

    The European Medicines Agency (EMA) has opened a consultation on the information changes to the summary of product characteristics (SmPC) and package leaflets mandated by the new European pharmacovigilance law.   The legislation requires the addition of information to the SmPC, which is aimed at healthcare professionals, and to the package leaflet, which is aimed at patients and consumers. This information is to include: a statement and a black symbol for m...
  • Australia Proposes Changes to How Sponsors Amend Approved Prescription Applications

    Australia's Therapeutic Goods Administration (TGA) announced on 12 June the impending release of proposed changes to how sponsors of registered prescription medications can make "minor variations" to the medicine's entry in the Australian Register of Therapeutic Goods (ARTG). TGA said the changes typically fall under one of four categories: corrections to the entry, a safety-related changes, "self-assessable" quality-related changes or Category 3 quality-level changes. T...