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Japan Plans To Smooth Trial Pathway For Foreign Ventures

 
• By Lisa Takagi

Japan plans to offer wider support to foreign firms and ventures with innovative candidates to start clinical trials in the country, as part of key measures from current prime minister Fumio Kishida.

Japan plans to start several services to support foreign firms' entrance into the country.
Japanese PM Fumio Kishida announces policies to drive national drug discovery activities • Source: Shutterstock

Japan is planning several measures to buttress the clinical trial capabilities of foreign bioventures and smooth the pathway for Japanese market entry, as part of a national initiative that aims to enhance the country’s drug discovery capacity and activities.

Key Takeaways

  • Japan planning multiple systems to ease entry of foreign innovative drug candidates.

  • These include a budget of $5.5m for a first-in-human clinical trial system to support cell and gene therapies.

  • Another $1

The budget plan for the Ministry of Health, Labour and Welfare (MHLW) for the fiscal year beginning 1 April 2025 includes JPY790m ($5.5m) to support first-in-human trial sites for novel modalities, and JPY270m ($1

More from Japan

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Japan Expands Priority R&D List For Regular Vaccinations

 
• By Lisa Takagi

Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.

More from Asia

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.