The regulation of cell therapy and gene therapy products in Switzerland

PK Bukovac, M Hauser, D Lottaz, A Marti… - … Cell Therapy Products …, 2023 - Springer
… information on a health technology assessment (HTA) … for the regulation of Advanced Therapy
Medicinal Products (ATMPs) in … products (TP), gene therapy medicinal products (GT) and …

Evaluating the Value for Money of Precision Medicine from Early Cycle to Market Access: a comprehensive review of approaches and challenges

W Chen, Y Wang, Y Zemlyanska, D Butani, NCB Wong… - Value in Health, 2023 - Elsevier
Health technology assessment (HTA) is a systematic and … how health technologies can
be used across different health … and development resources, product profile development, …

Prospects for harmonizing regulatory science programs in Europe, Japan, and the United States to advance regenerative medicine

CP Milne, J Mittra, N Kojima… - Therapeutic …, 2016 - journals.sagepub.com
… was its applicability to advanced technologies in Europe through the adoption in 2007 of
Regulation (EC) 1394/2007 on Advanced Therapy Medicinal Products (ATMP Regulation), …

[HTML][HTML] Guidance for the harmonisation and improvement of economic evaluations of personalised medicine

H Vellekoop, S Huygens, M Versteegh… - …, 2021 - Springer
… standards for health technology assessment (… evaluation of interventions in a range of
PM-related fields, such as genomic technologies [13], advanced therapeutic medicinal products

[HTML][HTML] Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider

Y Sato, H Bando, M Di Piazza, G Gowing, C Herberts… - Cytotherapy, 2019 - Elsevier
Health, Labour and Welfare (MHLW); and others, have introduced specific legislation and
guidelines to support the development of cell therapy medicinal productsadvanced therapies, …

[HTML][HTML] Recommendations to overcome barriers to the use of artificial intelligence-driven evidence in health technology assessment

A Zemplényi, K Tachkov, L Balkanyi… - … in Public Health, 2023 - frontiersin.org
… the Next Generation Health Technology Assessment to support patient-centered, societally
oriented, real-time decision-making on access to and reimbursement for health technologies

[PDF][PDF] An Idea About Utilization of Medical Technologies and Devices in Therapeutics and Diagnostic

S Sastry, B Suresh - tbeah.org
Health technology assessment also has been considered in … of health technologies that
includes medicinal products, … Robotic surgery is one of the best examples of therapeutic medical

DEVELOPMENT OF A REGULATORY GUIDELINEFOR CELL THERAPY MEDICINAL PRODUCTS IN THAILAND

P KIDPUN, R Chalongsuk - 2022 - ithesis-ir.su.ac.th
… to the emergence of Advanced Therapy Medicinal Products (ATMPs). These ATMPs entail
cell therapy medicinal products. These are emergence of new products. The objective of the …

Novel policy options for reimbursement, pricing and procurement of AMR health technologies

S Vogler, K Habimana, S Fischer, MA Haasis - 2021 - jasmin.goeg.at
… countries perform Health Technology Assessments (HTA). In an HTA, the cost-effectiveness
of the health technology is studied, taking into consideration its (added) therapeutic benefit (…

The Advanced Therapies Treatment Centers and Their Network: A Model for the Accelerated Adoption of Advanced Therapies

M Whitaker - Human Gene Therapy, 2022 - liebertpub.com
Therapy Catapult's (CGTC's) Annual Review that year identified 30 new advanced therapeutic
medicinal product (… scanning, health technology assessment, and submissions and the …