Izinqubomgomo nemithethonqubo: Isaziso Sesikhungo Sokuhlolwa Kwezidakamizwa Sombuso Wokulawulwa Kokudla Nezidakamizwa mayelana nokukhishwa Kwemihlahlandlela Yobuchwepheshe Yezinguquko Zemithi Ku-Marketed Biologic.

 KNOWLEDGE    |      2023-03-28

Muva nje, Isikhungo Sokuhlola Izidakamizwa (CDE) Sokulawulwa Kokudla Nezidakamizwa Sikahulumeni sikhiphe isaziso kokuthi "Imihlahlandlela Yobuchwepheshe Yezinguquko Zemithi Emikhiqizweni Yebhayoloji Emakethe (Isivivinyo)". Imihlahlandlela izosetshenziswa kusukela ngedethi yokukhishwa (Juni 25, 2021). Iqukethe izahluko ezingu-9 ezihlanganisa ukubuka konke, izimiso eziyisisekelo, izidingo eziyisisekelo, ukuguqulwa kwenqubo yokukhiqiza, ukuguqulwa kwezinto ezisiza ekubunjweni, ukuguqulwa kwezicaciso noma imininingwane yokupakisha, ukuguqulwa kwamazinga okubhalisa, ukushintsha kwezinto zokupakisha neziqukathi, ukushintsha kwesikhathi sokuqinisekisa noma izimo zokugcinwa. Izimiso eziyisiqondiso zisebenza emikhiqizweni yebhayoloji evikelayo, emikhiqizweni yebhayoloji yokwelapha, nasezintweni zokuxilonga ze-in vitro eziphethwe imikhiqizo yebhayoloji, futhi ichaza imibono eyisisekelo nokukhathazeka kocwaningo ngezinguquko ekubhaliseni nasekuphathweni kwemikhiqizo yebhayoloji ngemva kwemakethe.