Photo/Illutration Anti-flu drug Avigan, produced by an affiliate of Fujifilm Holdings Corp., is drawing attention as a potential treatment for COVID-19. (Provided by Fujifilm Holdings Corp.)

The health ministry on May 12 decided to allow pharmaceutical companies to bypass some clinical trial procedures for the fast-track approval of candidate drugs to treat COVID-19, including the anti-flu medicine Avigan.

The companies will not be required to submit the results of clinical trials in advance if the safety and efficacy of the drugs are confirmed in public studies that have received grants from the ministry or the Japan Agency for Medical Research and Development.

The exception to the pharmaceutical regulations was made as the world races to produce a vaccine or effective treatment to halt the novel coronavirus pandemic.

However, some health experts say the Japanese government, again, is rushing matters and could be putting people’s health at risk.

Clinical trials are conducted to confirm the safety and efficacy of pharmaceutical products, and the results are normally submitted to regulatory authorities when applying for approval.

The exception will be applied for drug applications that satisfy one of two requirements: public studies conducted on the drug meet global standards, or companies that developed the drug plan to conduct clinical trials and submit the results to the health ministry.

As for the latter requirement, the ministry will ask the companies to submit the results of the clinical trials after the drug is approved.

The ministry explained that the exception is aimed at putting effective COVID-19 medicine into practical use as quickly as possible.

Avigan was produced by Fujifilm Toyama Chemical Co. and approved for use as a treatment for new strains of influenza.

Prime Minister Shinzo Abe said the government plans to have Avigan approved as a treatment for COVID-19 by the end of May.

Although the results of Fujifilm Toyama Chemical’s clinical trials on Avigan for COVID-19 are expected to take some time, the drug has already been administered to many patients in observational studies carried out by doctors.

Under the ministry’s exemption, the company can apply for approval of the drug based on the results of the observational studies.

However, some studies have shown that Avigan used during pregnancy can have severe side effects on the fetus.

“The exception was made hastily,” said Jugo Hanai, who contracted HIV from tainted blood products and serves as a member of the Pharmaceutical Affairs and Food Sanitation Council, an advisory panel to the health minister.

“I understand there’s no other choice but using drugs that might be effective even a little bit since available treatment is limited, but the drugs should not be approved (in such a manner),” Hanai said.

“The approval would also allow such drugs to be used at medical institutions with a low level of pharmaceutical management and could result in causing side effects on patients.”

The Japanese government last week approved the use of the drug remdesivir, which was originally developed to treat Ebola virus infections, for treatment of COVID-19 patients.

Health experts in Japan have questioned the effectiveness of remdesivir against COVID-19 and raised concerns about possible side effects from its use.

(This article was written by Shuichi Doi and Hajime Mikami.)