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  • Regulatory NewsRegulatory News

    EMA, EUnetHTA Sign Off on Three-Year Work Plan

    The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan. Much of the 2017-2020 work plan builds on previous and ongoing efforts to streamline processes between regulators and health technology assessment (HTA) bodies. "By working together, EMA and EUnetHTA help medicine developers to improve clinical research and become more efficient in...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: New Gateway for Parallel Consultations on Marketing Authorizations, HTAs (6 July 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA, EUnetHTA Create Gateway for Parallel Consultations on Marketing Authorizations, HTAs European regulators and health technology assessment (HTA) bodies have advanced their plans to align the data sponsors need to win approval and secure reimbursement. The initiative takes the form of a gateway through which sponsors can request parallel consultations with the Europe...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EUnetHTA Nears Start of Third Phase of HTA Cooperation Agenda The European network for Health Technology Assessment (EUnetHTA) is on the cusp of entering the third phase of its agenda. Members of the European Commission and the Dutch National Health Care Institute began a 30-day countdown to the official start of the program by signing a grant agreement.  When the of...
  • Feature ArticlesFeature Articles

    Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps

    This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers who would like to enter this geographical market. In addition, solutions to maximize the product development strategy are discussed with the intention of bridging regulatory and market access gaps. The rapid diffusion of health technologies has presented governments with unprecedented challenges to provide high quality an...
  • 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 ...