Regulation of COVID-19 vaccines is imminent

It's possible to legislate immediately without a full review

As the "Special Act on the Development of Public Health Crisis Response Medical Products and the Emergency Supply" sub-enforcement decree passed the Regulation Reform Committee preliminary review, regulations and management such as COVID vaccines will be strengthened.

 

The MFDS plans to conduct a follow-up investigation of the public health crisis-response vaccine announced in April, report methods of abnormal cases, emergency production and import orders, and establish regulations on distribution improvement measures.

 

On the 25th, the Regulation Reform Committee judged all four regulatory provisions as "non-critical regulations" as a result of the MFDS' preliminary review of the Enforcement Decree of the Special Act on Public Health Crisis Response.

 

If non-critical regulations are determined in the Regulation Reform Committee preliminary review, the relevant ministries can proceed with enactment or revision of the regulation reform committee without submitting, deliberating, or deciding on the regulation reform committee's main review.

 

When classifying important regulations, the regulation reform committee or the main committee's review must be passed before the legislation and revision of the relevant ministries can be made.

 

Critical regulatory standards include the cost of more than ₩10 billion a year to be borne by regulated groups and citizens, or excessive levels of regulation in light of international standards.

 

The Enforcement Decree of the Special Act on Medical Products for Public Health Crisis Response determined by the Regulation Reform Committee as a non-critical regulation is a regulation established by ▲ tracking investigation and reporting methods ▲ registration of medical products subject to tracking investigation ▲ emergency production and import order and ▲ distribution.

 

Specifically, the method of tracking investigation and reporting abnormal cases is applied when it is recognized that it is necessary to check whether abnormal cases occur for a certain period of time.

 

Based on the special law, the method of tracking investigation reporting and the method of reporting abnormal cases may be specified in detail.

 

Statistics can be aggregated as abnormal cases and side effects can be reported through follow-up investigations after permission to market and treatments.

 

The registration of medical product details subject to follow-up investigation is a provision that allows the identification of the occurrence of abnormal cases when conditional item permission is obtained as a crisis-response medical product.

 

Conditional licensed products can be designated and managed as targets for follow-up investigation, so sales and supply details can be specifically determined from administration and registration.

 

The emergency production and import order procedure stipulates the contents of an emergency production and import order to secure the quantity of medical products necessary for responding to public health crisis.

 

The regulation allows those notified of emergency production and import orders to establish a production and import plan, submit it to the director of the MFDS, and report the results.

 

The distribution improvement measures procedure stipulates necessary measures for each person when determined to be subject to distribution improvement measures to respond to public health crises.

 

The MFDS is expected to take steps to enact enforcement ordinances that have been judged non-critically by the regulatory reform committee.

 

Regarding the need to introduce the regulations, the MFDS said, "It is urgent to introduce a supply system to manage the manufacture, import, and distribution of medical products necessary for the spread of COVID-19." The MFDS added, "The government should intervene to support the rapid development and emergency supply of medical products such as vaccines, treatments, masks, hand sanitizers, diagnostic kits, and artificial disposal."