Japan

Health products in Japan are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA) under the authority of the Ministry of Health, Labour and Welfare (MHLW). The primary governing legislation is the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), enacted in 2014 as a reform of the former Pharmaceutical Affairs Law. The approval process involves a technical review conducted by the PMDA, followed by a final approval decision issued by the MHLW. Products are classified by risk level: pharmaceuticals require full pre-market approval (shonin), while medical devices and in-vitro diagnostics may require either approval, certification (ninsho) by a Registered Certification Body (RCB), or notification (todokede) depending on their classification. Digital health products, including Software as a Medical Device (SaMD), are reviewed under medical device regulations, with PMDA having issued dedicated guidance aligned with international frameworks such as those from the International Medical Device Regulators Forum (IMDRF).

Foreign manufacturers seeking approval in Japan must designate a Marketing Authorization Holder (MAH), which must be a Japan-based legal entity, as foreign companies cannot hold a marketing authorization directly. Japan accepts the Common Technical Document (CTD) format for pharmaceutical submissions, in alignment with ICH guidelines, of which Japan is a founding member. Clinical data requirements have historically been stringent, with Japan often requiring bridging studies or Japan-specific trial data to address ethnic differences, though this requirement has been progressively relaxed under the SAKIGAKE designation system and through expanded acceptance of global multi-regional clinical trial (MRCT) data. Recent reforms include the SAKIGAKE priority review pathway for innovative products, Conditional Early Approval for products targeting serious conditions with unmet needs, and ongoing digitalization of submission processes. Japan is also actively participating in regulatory convergence efforts within the Asia-Pacific region through APEC and bilateral recognition frameworks.

Japan operates a universal public health insurance system under the National Health Insurance (NHI) framework, administered by the MHLW. Public procurement of health products is not conducted through a centralized national tender board; instead, reimbursement and pricing are determined centrally through the NHI Drug Price Standard (Yakka Kijun) for pharmaceuticals and the Coverage and Reimbursement Price (Hotetsu Kamoku) system for medical devices and diagnostics. These price lists are revised biannually (with major revisions every two years and interim adjustments in alternate years) through a process involving the Central Social Insurance Medical Council (Chuikyo). Hospitals and healthcare facilities, whether public or private, procure products at or below the listed NHI price, often negotiating volume-based discounts. Public hospital procurement is subject to government procurement regulations and may involve competitive bidding, while regional or prefectural health authorities manage procurement for public facilities within their jurisdictions. Market access therefore depends critically on NHI listing and favorable pricing decisions, which increasingly incorporate health technology assessment (HTA) elements, including cost-effectiveness analysis for high-cost products introduced through a formal HTA pilot program launched in 2019 and progressively expanded thereafter.

Japan's private healthcare sector is substantial, with private hospitals and clinics representing a large share of care delivery; these institutions procure through direct negotiations with distributors and manufacturers, guided by NHI reimbursement prices as a benchmark. Japan is a high-income country and does not receive procurement funding from multilateral donors such as UNICEF, the Global Fund, USAID, or Gavi; accordingly, these channels are not relevant to the Japanese market. Japan does not maintain explicit local manufacturing preference policies for health product procurement, though the COVID-19 pandemic prompted increased government focus on domestic supply chain resilience, leading to policy incentives and subsidies to encourage local production of vaccines, active pharmaceutical ingredients (APIs), and critical medical equipment. Companies entering the Japanese market typically do so through a domestic MAH or a licensed local distributor, and establishing a strong commercial partnership with an experienced Japanese entity remains a conventional and important market entry strategy.