Organization and Functions of MHLW in Japan
Organization and Functions of MHLW in Japan cover health, medical care, public health, pharmaceuticals and medical devices, labour, employment and social welfare. The Ministry of Health, Labour and Welfare (MHLW) is a cabinet-level ministry of the Government of Japan, established in 2001 through the merger of the former Ministry of Health and Welfare and the Ministry of Labour.
MHLW is responsible for a broad range of policies covering health, medical care, public health, pharmaceuticals and medical devices, labour and employment, social welfare and social security.
Organization and Functions of MHLW
Health and Public Health: MHLW develops and implements policies relating to healthcare, medical services, disease prevention and public health in Japan.
Pharmaceuticals and Medical Devices: MHLW oversees Japan’s regulatory framework for pharmaceuticals, medical devices and other regulated healthcare products, including requirements relating to their quality, efficacy and safety. For current regulatory information, see the Ministry of Health, Labour and Welfare pharmaceutical and medical device information.
Safety and Post-Marketing Measures: MHLW is responsible for policies and measures designed to identify, assess and manage safety issues associated with pharmaceuticals and medical devices after they reach the market.
Labour and Employment: MHLW develops and administers policies concerning employment, working conditions, labour standards and related social-security measures.
Social Welfare: The Ministry oversees policies and programs supporting older people, people with disabilities, children and other populations requiring social-welfare services.
Understanding the organization and functions of MHLW also requires understanding its relationship with the Pharmaceuticals and Medical Devices Agency (PMDA).
Role of PMDA
The Pharmaceuticals and Medical Devices Agency (PMDA) is an independent administrative agency operating under the jurisdiction of MHLW. It performs important regulatory functions including scientific reviews of pharmaceuticals and medical devices, regulatory consultations, safety-related activities and relief services for certain adverse health effects.
PMDA’s principal activities include reviews and related services, post-marketing safety measures and relief services for certain adverse health effects. These functions support MHLW’s regulatory responsibilities and contribute to the evaluation and continued monitoring of medicines and medical devices in Japan.
MHLW and PMDA therefore have complementary roles within Japan’s pharmaceutical and medical-device regulatory system: MHLW is responsible for regulatory policy and administrative oversight, while PMDA performs scientific review, consultation and safety-related functions that support regulatory decision-making.
For an overview of the wider regulatory framework, see Pharmaceutical Laws and Regulations in Japan.
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