Evidence-based decision-making on medical technologies in China, Japan, and Singapore

Abstract

Objective: To review the use of evidence in the market approval process, reimbursement, and price control mechanisms for medicines and medical devices in China, Japan, and Singapore. Methodology: Documentary reviews relevant to public health policy and management by government authorities. Results: Drug regulatory authorities play a vital role in the market authorization process of medical technologies. The approval criteria in the three countries are similar to those of the US Food and Drug Administration and many other countries, whose core measures are efficacy, safety, and quality, along with risk-based analyses in China and Singapore. All established the national drug list (Japan) or lists (China and Singapore) for reimbursement. Although Japan reimburses any drugs listed, China and Singapore selectively reimburse regarding the types of the list. The cost-effectiveness is utilized for prioritization of new drugs listed in Singapore. Japan controls the price by government, whereas Singapore keeps market liberalism, and China maintains a mixture of both. Conclusion: All three countries have established their own mechanisms, but cost-effectiveness requirements have not been fully introduced yet, partially applied to the reimbursement processes in Singapore. © 2009, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).