A market under close scrutiny

Over the last decade or so the Japanese regulatory bodies have succeeded in cutting the Market Authorization process down to 13 months. Firms must first register their requests with the Pharmaceutical & Medical Devices Agency, who assess the effectiveness, safety and quality of the new product. The Ministry for Health then issues an official decision, after consultation with the Council for Pharmaceutical Affairs, Food Safety and Public Health. While many foreign firms now launch new products directly without seeking local partners, some multinationals still prefer to form strategic alliances with specialists on the ground.