• EMA Looks to Allow More Regulatory Flexibility for Pediatric Plan Submissions

    The European Medicines Agency (EMA) has announced the publication of a new policy on making changes to pediatric investigation plan (PIP) decisions. PIPs are mandated by Regulation EC 1901/2006, which states that any medicinal product intended for pediatric use must include a plan to conduct testing sufficient to obtain necessary data to support a marketing authorization application (MAA). A PIP is also necessary when applying for new indications, new routes of administr...
  • FDA Announces Planned Update to Electronic Common Technical Document

    The US Food and Drug Administration (FDA) announced its intent to hold a meeting to update stakeholders on the changes it plans to make to Module 1 of the Electronic Common Technical Document (eCTD), which is used to describe administrative and prescribing information for medicines. The eCTD is a standardized application form developed in conjunction with the International Conference on Harmonization (ICH) and its member parties. Both the Center for Drug Development and ...
  • 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...
  • FDA Plans Major Overhaul of Recall Reporting

    The US Food and Drug Administration's (FDA) weekly enforcement reports, which detail product recalls and corrections taken during the week, are about to get a major overhaul according to an agency announcement. The agency last week reported in a little-noticed item within its enforcement report that it would be making changes to the way it updates its enforcement reports for pharmaceutical product recalls. The agency wrote at the time it intends to "modify the drug pro...
  • EMA Prepares for 'Biggest Change' to Legal Framework Since Founding

    The European Medicines Agency (EMA) announced on 2 February that it "is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework since the establishment of the Agency in 1995." New pharmacovigilance legislation being enacted in July will harmonize adverse drug reaction reporting for all citizens across the EU, according to a statement released by EMA. The legislation also make...