Regulatory and HTA early dialogues in medical devices.
Sign Up to like & getrecommendations! Published in 2021 at "Health policy"
DOI: 10.1016/j.healthpol.2021.07.010
Abstract: INTRODUCTION Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development. A more intense dialogue of competent authorities, HTA agencies, and manufactures may improve evidence base on… read more here.
Keywords: hta agencies; competent authorities; regulatory hta; hta early ... See more keywords
Analysis of GMP for marketing authorization of ATMPs: comparison in the US, the EU, Japan and South Korea.
Sign Up to like & getrecommendations! Published in 2022 at "Regenerative medicine"
DOI: 10.2217/rme-2021-0153
Abstract: Aim: This study compared regulatory systems of competent authorities related to GMP for marketing authorization of advanced therapy medicinal products (ATMPs). Methods: Dossiers for GMP and regulations and guidelines for facilities and equipment were analyzed… read more here.
Keywords: gmp marketing; authorization; japan south; south korea ... See more keywords