… Advanced therapy medicinal products (ATMPs) are among the most complex pharmaceuticals
with high human specificity. Species differences severely limit the clinical relevance of in …

… Advanced therapy medicinal products (ATMPs) are a group of … biological medicines that
offer novel therapeutic opportunities … therapy medicinal products (GTMPs), somatic cell therapy …

… Advanced therapy medicinal products (ATMPs) are rapidly evolving to offer new treatment
options. The scientific, technical and clinical complexities subject drug … technology evaluation …

… Novel, complex treatment strategies such as health technologies with concomitant genetic
testing, advanced therapy medicinal products (ATMPs) or the assessment of sequences of …

Full article: An accelerated access pathway for innovative high-risk medical devices under
the new European Union Medical Devices and health technology assessment regulations? …

… , improve safety and access to advanced therapies include: facilitating R&D by adaptive,
risk… , regulatory authorities as well as health technology assessment bodies and payers alike. …

… The Hospital Exemption (HE) was enacted to accommodate manufacturing of advanced
therapy medicinal products (ATMPs) for treatment purposes. However, how its implementation …

… health technologies Our survey shows that many international health technology assessment
(HTA) agencies currently lack detailed guidance for the evaluation of health technologies …

… therapies are a novel treatment approach, they may be assessed by health technology
assessment (… A standardised approach to gene therapies has not been elaborated yet. Moreover, …

… ’ technologies such as advanced therapy medicinal products (ATMPs), defined as “medicines
for … Emerging developments in immunotherapy in cancer and gene therapy, will lead to an …