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.
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 to the country’s existing Pharmaceutical and Medical Device Act, which passed the House's main session
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.
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.
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 adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.
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.
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.
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.
