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Objectives: This study aimed to provide an exhaustive description of criteria and methodological recommendations for evaluating them in health technology assessment (HTA) in Western and Asian countries., Methods: We conducted a system literature review of HTA-related guidelines by searching the websites of HTA agencies and related data sources. The guidelines, reports, or recommendations introducing the HTA evaluation methods, processes, decision-making frameworks, and criteria for priority setting were eligible to be included. The review was limited to guidelines from countries belonging to the European Network for Health Technology Assessment (EUnetHTA) and HTAsiaLink organisations and other countries with well-established available guidelines., Results: A total of 52 guidelines from 24 countries were identified, including 13 countries from the EUnetHTA organisation, 9 countries from the HTAsiaLink organisation and 2 other countries (Canada and the USA). A strong consensus was observed among the HTA agencies on the core set of criteria including efficacy or effectiveness, cost-effectiveness, safety, and budget impact. More similarities were observed than differences in methodological recommendations for clinical and economic evaluations among the agencies., Conclusions: Substantial convergence is seen in the criteria included in the HTA process, as well as the methods to evaluate and quantify them. Further efforts are needed to verify whether the criteria identified from the guidelines are incorporated in real HTA decisions, and how they are assessed and weighted in practice.

Background: A small number of regenerative medicines (RMs) have received market authorization (MA) worldwide, relative to the large number of clinical trials currently being conducted. Regulatory issues constitute one major challenge for the MA of RMs., Objective: This study aimed to systematically review the regulation of RMs internationally, to identify the regulatory pathways for approved RMs, and to detail expedited programs to stimulate MA process., Methods: Official websites of regulatory authorities in 9 countries (United States (US), Japan, South Korea, Australia, Canada, New Zealand, Singapore, China, and India) and the European Union (EU) were systematically browsed, and was complemented by a systematic literature review in Medline and Embase database., Results: Specific RM legislation/frameworks were available in the EU, US, Japan, South Korea and Australia. A risk-based approach exempting eligible RMs from MA regulations were adopted in the EU and 6 countries. All investigated regions have established accelerated review or approval programs to facilitate the MA of RMs. 55 RMs have received MA in 9 countries and the EU. Twenty-three RMs received Priority Medicine designation, 32 RMs received Regenerative Medicine Advanced Therapy designation, and 11 RMs received SAKIGAKE (fore-runner initiative) designation., Conclusion: Regulators have adopted proactive strategies to facilitate RM approval. However, addressing the discrepancies in regulatory requirements internationally remains challenging., Competing Interests: Declaration of Competing Interest All authors have no conflicts of interest to report in this work. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors., (Copyright © 2020 Elsevier B.V. All rights reserved.)