Fast-track enables companies to skip queues and processing in registration steps in parallel to pricing. EU/EMA Priority Increased HA Innovative product for target Early appointment Medicines collaboration conditions where there is an of CHMP Scheme to support unmet medical need in rapporteur and (PRIME) expedited relation to which the dedicated EMA development medicinal product concerned contact point and potential will be of major therapeutic Dedicated and for expedited advantage to those affected reinforced support review AND available data supports Enhanced dialogue the claim that the product has to support the potential to bring a major development therapeutic advantage to Enable AA patients in a given indication, Better use of through a clinically meaningful existing regulatory improvement of efficacy, such procedural tools as having an impact on the prevention, onset and duration of the condition, or improving the morbidity or mortality of the disease. EU/EMA Accelerated Expedited Medicinal products of major Shortened review time Assessment review interest from the point of view of public health and in particular from the view point of therapeutic innovation EU/EMA Conditional Expedited Seriously debilitating or Approval may be Approval development diseases OR use granted at an earlier in emergency situations OR an time point, subject to orphan medicines AND specific obligations for benefit-risk balance confirmatory studies of the product is positive; comprehensive data will be provided; and unmet medical needs will be fulfilled; EU/EMA Exceptional Expedited When comprehensive data on Full data package not Circumstances development the efficacy and safety under required normal conditions of use cannot be provided, because: rare disease/condition scientific knowledge is not yet developed unethical Indonesia Priority Expedited Products that are life-saving, Shortened review time review review serve unmet medical needs
Fast-track enables companies to skip queues and processing in registration steps in parallel to pricing. EU/EMA Priority Medicines Scheme (PRIME) Increased HA collaboration to support expedited development and potential for expedited review Innovative product for target conditions where there is an unmet medical need in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected AND available data supports the claim that the product has the potential to bring a major therapeutic advantage to patients in a given indication, through a clinically meaningful improvement of efficacy, such as having an impact on the prevention, onset and duration of the condition, or improving the morbidity or mortality of the disease. Early appointment of CHMP rapporteur and dedicated EMA contact point Dedicated and reinforced support Enhanced dialogue to support development Enable AA Better use of existing regulatory procedural tools EU/EMA Accelerated Assessment Expedited review Medicinal products of major interest from the point of view of public health and in particular from the view point of therapeutic innovation Shortened review time EU/EMA Conditional Approval Expedited development Seriously debilitating or diseases OR use in emergency situations OR an orphan medicines AND benefit-risk balance of the product is positive; comprehensive data will be provided; and unmet medical needs will be fulfilled; Approval may be granted at an earlier time point, subject to specific obligations for confirmatory studies EU/EMA Exceptional Circumstances Expedited development When comprehensive data on the efficacy and safety under normal conditions of use cannot be provided, because: rare disease/condition scientific knowledge is not yet developed unethical Full data package not required Indonesia Priority review Expedited review Products that are life-saving, serve unmet medical needs Shortened review time