Japan Diet OK’s bill for emergency approval of drugs

Jiji Press

17:34 JST, May 13, 2022

TOKYO (Jiji Press) — The Diet, Japan’s parliament, on Friday enacted a bill to create a system granting emergency regulatory approval to vaccines, drugs and other medical goods in urgent situations such as when an infectious disease is spreading.

The bill to amend the pharmaceuticals and medical devices law was approved unanimously at a plenary meeting of the House of Councillors, the upper chamber of the Diet, on the day. The amendment cleared the House of Representatives, the lower chamber, earlier.

Under the system, regulatory approval would be given to drugs and vaccines even before the completion of clinical trials if their safety is confirmed and their effectiveness can be estimated.

The establishment of the system comes after Japan lagged behind the United States and European countries in putting COVID-19 vaccines to practical use.

Vaccines that are being distributed overseas and estimated to be effective, for example, can be given emergency approval without clinical trials in Japan, enabling quicker distribution than under the current special pharmaceutical approval system.

The new system is also aimed at supporting Japanese companies’ drug and vaccine development, with domestically developed products possibly be approved even during clinical trials.

The system covers pharmaceutical products and medical equipment necessary during times of emergency that could greatly affect people’s lives and health, such as when an infectious disease is spreading widely and during a nuclear accident. Safety of such goods will be confirmed using existing standards.

The emergency approval will be revoked if the effectiveness is not confirmed within about two years after the start of practical use.