Japan Drug Registration and Approval
Freyr provides Japan Drug Registration and Approval support for pharmaceutical manufacturers that includes product classification, registration and approval for regulatory compliance as per PMDA regulations. The Pharmaceuticals and Medical Devices Agency (PMDA), operating under the Ministry of Health Labour and Welfare (MHLW), remains the regulatory authority responsible for overseeing the registration of medicinal products in Japan. Compliance with the Pharmaceuticals and Medical Devices Act (PMD Act) is mandatory for all pharmaceutical companies seeking market approval in the country.