Japan Progresses 'Urgent Approval' System To Speed Drug Access

Tighter Monitoring Would Be Required

21 Apr 2022

Japan is intending to revise existing pharma legislation to enable the urgent approval of new drugs with "assumed efficacy", with a maximum three-year period for confirmation, in cases of emergency need. The government will also ask companies to implement tighter safety monitoring and management of supply chains, with swift data disclosure required, as part of the planned changes.

Urgent approval with much faster process to be enabled in Japan — new Japan system wouid skip confirmation process in case of emergency • Source: Alamy

Japan is planning to implement a system that would enable the urgent approval of new drugs without full confirmation of efficacy as long as this can be reasonably assumed from existing data and if the product is the only measure to tackle an urgent domestic health crisis.

The Committee on Health and Labour, Welfare of the House of Representatives decided on 15 April to pass a revision...