Japan Diet OK’s bill for emergency approval of drugs
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.
"POLITICS" POPULAR ARTICLE
Defense minister to China: Concerns exist between Japan and China
Japan scrambled aircraft 4.5 times more this May than last
Japan’s de facto aircraft carrier Izumo to be dispatched to Indo-Pacific from mid-June
20,000 digital advisers eyed to support silver surfers
U.S. ambassador sees Japan-U.S. alliance shifting to a larger domain
JN ACCESS RANKING
- Japan, Finland confirm unity in dealing with Russia
- Mangaka Fujiko Fujio A dies at 88
- China’s aircraft carrier drills near Japan aimed at around-the-clock attack capability
- Fukushima lab releases images of ‘highly likely’ UFOs
- As wheat prices soar, Japanese food industry pushes rice flour as alternative