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In preparation for a future pandemic, the government has started discussions on introducing emergency use authorizations for unapproved vaccines and medicines.
Learning from the current COVID-19 pandemic, in which Japan lagged behind the United States and Europe in its vaccination rollout, the government hopes to compile its plan by the end of this year and submit a bill to an ordinary Diet session next year.
In the pandemic, the U.S. Food and Drug Administration made use of its emergency use authorization (EUA) system to allow the use of unapproved vaccines based on interim data, giving a green light to use the Pfizer-BioNTech vaccine about three weeks after its application was filed.
In Japan, a special approval system under the pharmaceuticals and medical devices law was applied to simplify the screening of vaccines available overseas. Even so, the process took about two months.
Based on lessons learned, the government will start simplifying and shortening its approval system, specifically by revising the law and setting up a rule for screenings that can be conducted as fast as those in the United States and Europe without comprehensive data.
The European Union, meanwhile, has “conditional marketing authorization” that allows sales of drugs in the EU for a specified period on the basis of less comprehensive data than normally required.
Since the latter half of the 1980s, the Japanese government has repeatedly lost lawsuits over adverse reactions to vaccinations and damage caused by drugs. The situation became a social problem and created a “vaccine gap,” in which vaccines developed in the West are approved more than 10 years later in Japan.
In the United States, EUAs have a disclaimer that exempts the government and drug makers from liability for damage to health. Some within the Japanese government have insisted that in light of past circumstances, the government should stipulate its own responsibility in advance, and also draw up a relief plan, even if companies are to be protected from liability.
Japan’s current special approval system can only be applied to drugs that have been distributed overseas, but not domestic drugs. Discussions will include whether a new system would cover domestic vaccines once they are developed.
At a Cabinet meeting in June, the government approved a national strategy to strengthen vaccine development and production, which was compiled by an industry-academia-government group. The strategy calls for improving the speed and predictability of approvals, including those for imported vaccines.
