Differences in evidentiary requirements for oncology drug effectiveness assessments among six European health technology assessment bodies—can alignment be …

S Wolters, LA de Jong, C Jansen… - Expert Review of …, 2024 - Taylor & Francis
assessments, joint clinical assessments will also be carried out for advanced therapy medicinal
products… joint clinical assessments will be performed for all medicinal products approved …

[HTML][HTML] Emerging technologies for quality control of cell-based, advanced therapy medicinal products

S Zia, V Pizzuti, F Paris, F Alviano, L Bonsi… - … of Pharmaceutical and …, 2024 - Elsevier
… the evaluation by the EMA Committee for Advanced Therapies (… Health Technology
Assessment (HTA) body must wait for the EMA opinion before assessing the risk/benefit of a therapy, …

[PDF][PDF] Valuing Health: Exploring potential drivers of reimbursement decision-making in health technology assessments for orphan drugs and rare diseases

A Wong An Qi - 2022 - duo.uio.no
… a drug or procedure and the patient pays the remainder, and Health Technology Assessment
(… between healthcare payers and medical product manufacturers are futile if capturing and …

[HTML][HTML] Financing and reimbursement of approved advanced therapies in several European countries

C Iglesias-López, A Agustí, A Vallano, M Obach - Value in Health, 2023 - Elsevier
advanced therapy medicinal products (ATMPs) is a current challenge for their reimbursement
in health … NHAs reports, such as health technology assessments (HTAs) and other official …

Health Technologies and Pharmaceuticals programme: annual report 2017

World Health Organization - 2017 - apps.who.int
… Prequalification of medicines is a service WHO provides to assess the quality, safety and
efficacy of medicinal products for a number of priority diseases. Prequalification is intended to …

Advanced Therapy Medicinal Products: New Strategies for Clinical Applications of Cell and Gene Therapy

MABR de Carvalho - 2020 - search.proquest.com
Advanced therapy medicinal products (ATMPs) have a massive potential to address
existing unmet medical needs. Specifically, gene therapy medicinal products (GTMPs) may …

[HTML][HTML] Towards a European harmonization of health technology assessment recommendations executive paper of European regulatory conference focused on the …

L Gozzo, K Paterson, O Wong, F Megerlin… - Frontiers in Drug …, 2022 - frontiersin.org
… enable rapid, EU-wide authorisation of medicinal products. … health technology assessment
and amending Directive 2011/24/EU. European Commission, Directorate-General for Health

Rational drug use, formulary management, pharmaceutical care/medication therapy management/pharmacists' patient care process

S Zachariah, A Hill, D Thomas, OG Al Ahdab… - … Education, Practice and …, 2019 - Elsevier
… all pharmaceutical products together is by calling them “health technology.” This includes …
guidelines for the rational use of drugs and other pharmaceutical products. WHO uses the term …

Report of the international regulatory forum on human cell therapy and gene therapy products

T Hayakawa, I Harris, J Joung, N Kanai, S Kawamata… - Biologicals, 2016 - Elsevier
advanced therapy medicinal products … These products were called advanced therapy
medicinal products (… cell-based/gene therapy medicinal products places special requirements on …

[HTML][HTML] Adaptation through collaboration: developing novel platforms to advance the delivery of advanced therapies to patients

M Papadaki - Frontiers in medicine, 2017 - frontiersin.org
advanced therapies. This work explains that reinventing an adoption route for Advanced
Therapy Medicinal Products … that shift influence from Health Technology Assessment (HTAs) to …