Advanced Therapy Medicinal Products (ATMPs), including gene (GTMP), cell (CTMP) and tissue-engineered products (TEP) can only be applied under European regulatory framework within:
• A clinical study protocol
• Hospital Exemption (HE)
• Marketing Authorization (MA)
In Europe, only 5 ATMPs achieved MA, while many clinical trials with ATMPs are conducted. Many ATMPs are developed in academic institutions but seem to remain in development phase. Is there a problem in the development route for ATMPs?
Read more: ATMP_Netherlands