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Promising development for clinical studies in Romania

The National Agency for Medicines and Medical Devices of Romania (NAMMDR) is established by reorganization of the former National Agency for Medicines and Medical Devices (NAMMD).
By strengthening the status of national competent authority in the field of human medicine and medical devices, while operating with an ethical and civic sense to ensure that all Romanian patients have access to innovative treatments, the new direction of the Agency will focus on the following aspects:

  • the recovery of the delays and the creation of a predictable framework (in accordance with the terms stipulated in the legislation);
  • transparency of the activity;
  • implementation of the reorganization plan and efficiency of some workflows;
  • communication with all interested parties (pharmaceutical industry, patient associations, other state institutions and other EU member states).

    The number one priority of ANMDMR, remains the patient’s health. In this regard, the agency has already recorded a remarkable evolution in the first 6 months of the current year regarding the completion of the remaining files, as shown in their publication from 5.08.2019.

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