Читать книгу Biologics, Biosimilars, and Biobetters - Группа авторов - Страница 65

Until recently, reviews and related operations for pharmaceutical medications were handled by two organizations. The Pharmaceuticals and Medical Devices Evaluation Center (PMDEC) was the main product review body comprising of 8–10 specialists while the Organisation for Pharmaceutical Safety and Research (OPSR or KIKO or DO) was an independent consultation body. The PMDEC and KIKO worked closely together and both made use of “experts,” which would often comprise the same people. The Ministry of Health, Labour and Welfare (MHLW) supervised PMDEC and KIKO and granted approval. As part of the reforms that have been ongoing recently, the PMDEC and KIKO, along with the Japanese Association for the Advancement of Medical Equipment (JAAME), were merged in April 2004 to form the Pharmaceuticals and Medical Devices Agency (PMDA). The PMDA now handles the whole process from clinical study stage, providing “face to face” advice, through the approval phase and is also responsible for post marketing safety measures. The PMDA comprises 25 work sites, 6 groupings (or sections), and the Kansai and Hokuriku branches. The PMDA is currently attempting to accomplish objectives under the Third Medium Range Plan (2014–2018). The role of the PMDA is to provide consultations concerning the clinical trials of new drugs and medical devices, and to conduct approval reviews and surveys of the reliability of application data.⁶