Japan Progresses 'Urgent Approval' System To Speed Drug Access

Tighter Monitoring Would Be Required

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Japan

Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By 

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.

Citeline Japan Awards 2025 - Enter Now!

 

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By 

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By 

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.

More from Asia

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

New Era Begins In Korea: Policy Predictions For Biopharma

 
• By 

As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.

Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.