In response to the fact that approval of the new corona vaccine was delayed compared to overseas, Prime Minister Kishida entered into deliberation in the House of Representatives on a bill to revise the law to establish a new system for "urgent approval" of vaccines and therapeutic drugs. The minister emphasized the significance of the system as a mechanism that enables the people to deliver the necessary medicines faster.
Amendments to the Pharmaceuticals and Medical Devices Act, etc., have an "emergency approval" system that enables swift regulatory approval of vaccines and therapeutic agents developed in Japan and overseas, provided that there is no alternative means in an emergency such as an epidemic of infectious diseases. Is included in the new establishment.
The amendment was deliberated at the plenary session of the House of Representatives on the 31st, and Prime Minister Kishida said, "The emergency approval system to be established is a mechanism to promptly give regulatory approval when the effectiveness is estimated, on the premise of confirming safety. We will be able to deliver the necessary medicines to the people as soon as possible. "
On the other hand, regarding the safety measures for drugs that have been "urgently approved", Prime Minister Kishida said, "The system is such that approval can be promptly revoked when serious side effects are found. After marketing, drug safety monitoring by manufacturers and distributors. We will take safety measures firmly by formulating plans and utilizing a mechanism that allows patients to report cases of suspected side effects of drugs or side effects of vaccines. "
In addition, at the plenary session, a bill submitted by the Constitutional Democratic Party that included the strengthening of the government's control tower function was also deliberated so that doctors and beds to deal with the new corona could be coordinated between prefectures. ..