Fight infectious diseases with speed through emergency drug approval

A cornerstone of infectious disease control is to develop vaccines and pharmaceutical products swiftly and facilitate their availability. It is hoped that a system will be established to allow safe medicine to be used quickly.

The government has approved a bill to revise the Pharmaceuticals and Medical Devices Law. The establishment of an emergency approval system for vaccines and pharmaceutical products has been set as a pillar of the revision. It intends to enact the bill during the current Diet session.

One reason the national COVID-19 vaccination program stalled is that regulatory approval for vaccines was granted in Japan two to five months later than in Western countries because additional trials on Japanese people required more time.

It stands to reason that the current procedures will be changed to allow medical products to be secured promptly in emergencies. To respond to COVID-19 and in preparation for new infectious diseases, the government is urged to develop a system to deliver new drugs to the people as soon as possible.

A medical product is usually approved after its safety and efficacy are confirmed in a three-stage clinical trial. Under the new emergency approval system, if the product is presumed to be effective after its safety has been confirmed, its use will be authorized provisionally by allowing the final phase of the approval process to be completed in a shorter period of time.

This measure will be applicable to public health emergencies, such as an outbreak of an infectious disease, as well as nuclear accidents or bioterrorist incidents. It is said that the approval of the product will be retracted if its effectiveness is not confirmed within a period of about two years.

An emergency use authorization mechanism that was adopted for COVID-19 vaccines and drugs in the United States was used as a reference for devising this measure. It is a step forward for Japan that similar procedures can be taken in the future. The agile use of such a system is urged, with the safety of pharmaceutical products to be ensured thoroughly yet without excessive caution.

There might be cases in which pharmaceutical products prove ineffective or have unexpected side effects once they become widely used. The government should strengthen its mechanism for looking out for problems and making swift judgments should they occur.

Under the new system, the effectiveness of a medical product with fast-track approval could remain partially uncertain compared to those of a product that undergoes regular authorization procedures. It is also essential for the government to carefully explain this matter to the public.

The emergency approval system is expected to cover not only pharmaceutical products with substantial track records overseas but also those developed in Japan. If a product’s effectiveness is highly expected as a result of a small-scale clinical trial, it can be put into practical use without a large-scale trial.

The new system would also help develop new drugs in Japan. It is necessary to conduct appropriate screenings in line with overseas standards.

Some Japanese pharmaceutical companies have the ability to develop promising medicines. However, they have a weak foundation for conducting clinical trials for reasons such as the difficulty in finding clinical trial participants. This has hindered the practical application of their products.

The government has launched efforts to place specialists at medical institutions that conduct clinical trials in order to carry out joint trials with other Asian countries. It is crucial for the public and private sectors to strengthen cooperation further to develop effective new drugs.

— The original Japanese article appeared in The Yomiuri Shimbun on March 11, 2022.