Market Access Overview

Executive Summary

The MA (marketing authorisation) process in Japan collaborates with the reimbursement procedure.

Step 1: Manufacturers submit their NDA (New Drug Application) to the MHLW (Ministry of Health, Labour and Welfare). The application is reviewed by the PMDA (Pharmaceutical and Medical Devices Agency), who provides their recommendation and GMP assessment results to MHLW which, in consultation with the PAFSC (Pharmaceutical Affairs and Food Sanitation Council), makes the final MA decision.

Step 2: Drugs that are approved are added to the NHI (National Health Insurance) list for pricing negotiations. The standard drug review process takes around 12 months. Priority reviews for innovative pharmaceuticals, medical devices and regenerative medicines which can cure serious illnesses (rare diseases, cancer etc.) where no alternative therapy exists takes 6 months through the Strategy of SAKIGAKE. Pricing decisions are made by the DPO (Drugs Pricing Organisation) following a short negotiation process with the MHLW, with final approval from Chuikyo (Central Social Insurance Medical Council). In April 2019 a new pricing process based on cost-effectiveness evaluation by Chuikyo was incorporated into the system, for medical drugs and devices whose peak expected annual sales are estimated to be ¥100 billion ($900 million) or more. If the MHLW and Chuikyo agree on the price, it is listed on the NHI price list within 60 to 90 days. Drug prices are adjusted every 2 years.

MAP provides insights on: