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  • Regulatory NewsRegulatory News

    EMA, Payors Team up to Speed up Assessments of Medicines

    In the EU, a product must clear two hurdles before it can reach patients. First, it must be approved by regulators, such as the European Medicines Agency (EMA), which determines if a product is safe and effective. Thereafter, the product is evaluated by health technology assessment (HTA) bodies, which determine if the product is suitable for reimbursement according to the standards of various countries. Now, EU regulators and reimbursement bodies are teaming up in ...
  • Feature ArticlesFeature Articles

    Should Regulatory and Reimbursement Be Linked?

    The functions of determining regulatory approval and reimbursement for a product traditionally have been at opposite ends of the development process. Historically, any product that received regulatory approval was reimbursed by payers. This is no longer the case in today's global market. While regulatory approval by a single body is still the basic requirement for commercializing a product, obtaining optimal reimbursement requires interaction with many diverse public an...
  • Feature ArticlesFeature Articles

    The Need for More Certainty in Reimbursement Strategies

    Integrating Health Outcome Parameters with Clinical Development For drug developers, getting a treatment to market with regulatory approval is proving to be only half the battle. Once in Phase 4, applying for reimbursement approval prompts an entirely new process, which can differ considerably from regulatory approval in terms of the health outcomes and evidence parameters that are evaluated. Regulatory approval, once considered the gold standard, is no longer good eno...