Drug Development in Japan
Drug development in Japan follows a regulated pathway designed to establish the quality, efficacy and safety of new pharmaceutical products. The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) have complementary roles throughout development, regulatory review and post-marketing safety.
Drug Development in Japan: Preclinical Development
Before a new drug enters clinical development, nonclinical studies are conducted to evaluate areas such as pharmacology, pharmacokinetics and toxicology. Applicable studies supporting regulatory submissions must comply with relevant standards and Good Laboratory Practice (GLP) requirements.
Regulatory Consultation
PMDA provides regulatory consultations during drug development. Sponsors and developers can obtain scientific and regulatory advice on development strategies, nonclinical studies, clinical trial plans and data required for future regulatory submissions.
Early interaction with PMDA can help developers identify regulatory expectations and address important scientific or development issues before submitting an application for marketing approval.
For current regulatory guidance and consultation information, see the Pharmaceuticals and Medical Devices Agency (PMDA).
Clinical Development and Clinical Trials in Japan
Clinical trials intended to support marketing approval are conducted under Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) and applicable Good Clinical Practice (GCP) requirements.
For applicable investigational drugs, sponsors submit clinical trial notifications to PMDA. Clinical development generally progresses through phased studies designed to evaluate safety, dosage, efficacy and the overall benefit-risk profile of the investigational product.
For an overview of the broader regulatory framework, see Pharmaceutical Laws and Regulations in Japan.
Marketing Approval Application
After sufficient quality, nonclinical and clinical evidence has been generated, an application for marketing approval can be submitted in Japan.
The application includes information and data concerning the product’s quality, efficacy and safety. Regulatory submissions for new drugs are reviewed by PMDA.
PMDA Review and MHLW Approval
PMDA performs the scientific review of the submitted application and evaluates whether the available evidence supports the quality, efficacy and safety of the pharmaceutical product. The review process may also involve inspections and assessment of compliance with applicable regulatory standards.
Following the regulatory review process, approval for a new pharmaceutical product is granted within the MHLW regulatory framework.
Manufacturing and Quality
Manufacturing processes and facilities must meet applicable quality and Good Manufacturing Practice (GMP) requirements. Regulatory inspections and quality assessments help ensure that products are consistently manufactured and controlled according to established standards.
Post-Marketing Safety
Regulatory responsibilities continue after approval. Marketing authorization holders are required to monitor product safety, collect and evaluate safety information and comply with applicable pharmacovigilance and post-marketing requirements.
MHLW and PMDA may take regulatory or safety measures when new information changes the understanding of a product’s risks and benefits.
Drug development in Japan therefore extends from preclinical research and clinical development through regulatory review, approval, manufacturing and continuing post-marketing safety surveillance.
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