Reasons for Proposal
Notwithstanding the rapid development of science and technology, the development and supply of drugs, quasi-drugs, and medical devices to efficiently deal with public health crises such as pandemics, biochemical terrorist attacks, and radiation accidents are often not sufficient, and thus there are increasing calls in society for enhancing the publicness of the pharmaceutical sector by building a system that has the capacity to promote the development of necessary products with rapid licensing and development support for medical products to preemptively respond to public health crises.
In addition, in light of the cases in response to the supply of face masks, hand sanitizers, etc. following the recent spread of COVID-19, circumstances demand the introduction of exceptions to adjust the manufacturing, importation, and sales of medical products to urgently respond to public health crises.
However, since current individual statutes such as the “Pharmaceutical Affairs Act” and the “Medical Devices Act” do not fully provide an institutional framework to support the rapid development or urgent supply of medical products, it is necessary to devise separate systems to support the rapid development and urgent supply of overall medical products required, including vaccine and medication drugs, quasi-drugs such as face masks and hand sanitizer, and medical devices such as test kits and heart-lung machines.
Therefore, the Act aims to preemptively respond to public health crises and protect the safety and health of the people by establishing systems for the designation, preferential examination, continuous joint examination, conditional approval system, etc. for medical products for public health crises to promote the rapid development of medical products while building systems to urgently supply the medical products required for public health crises, such as emergency production and importation orders, and distribution management.
Details
A. Introduction of the designation system for medical products for public health crises (Article 6)
Introduce a medical product designation system for public health crises to support the rapid development of medical products to combat public health crises, and set forth the data to be submitted for the designation application and the designation requirements and procedures.
B. Preferential examination of medical products for public health crises (Article 7)
If marketing approval or a clinical trial protocol is applied for a medical product to combat a public health crisis, allow the product to undergo preferential examination over other medical products to ensure the rapid supply of medical products for public health crises.
C. Continuous joint examination of medical products for public health crises (Article 8)
Require the submission and early examination of results such as clinical trials by development stage and reduce the examination period for medical products for public health crises.
D. Conditional marketing approval for medical products for public health crises (Article 9)
When applying for marketing approval of medical products for public health crises, as for a medical product that cannot be tested on a person due to ethical reasons, etc. or a drug whose form and purpose of therapeutic exploratory clinical trials are similar to therapeutic confirmatory clinical trials, allow the data to be submitted at the time of application for approval to be replaced by other data or simplified, while granting conditions.
E. Measures for the safe use, etc. of medical products for public health crises (Article 11)
Require those who obtain marketing approval for medical products for public health crises to report after enforcing measures for safe use and conducting an investigation on performance during use, and allow the Minister of Food and Drug Safety to order additional measures on safe use if required according to the reported results.
F. Report on the side effects of medical products for public health crises (Article 12)
Require a person who obtains marketing approval for medical products for public health crises to report to the head of the Korea Institute of Drug Safety & Risk Management if he/she is aware of a case regarding safety and efficacy, and require the Minister of Food and Drug Safety who is notified of the analysis results by the head of the Korea Institute of Drug Safety & Risk Management to determine whether to allow the continued use of the corresponding medical product if it is determined to cause severe danger.
G. Follow-up study on medical products for public health crises and registration of use history (Article 13)
Allow follow-up studies to be conducted for medical products for public health crises that are deemed necessary for verification of whether abnormalities have occurred during a certain period of time after use, and permit necessary measures for public health to be enforced depending on the follow-up survey results.
H. Project to support the use of medical products for public health crises (Article 14)
Allow a person who obtains marketing approval for medical products for public health crises to engage in a project to support the use of medical products for crises by means such as providing medical products without charge.
I. Support for the development of medical products for public health crises (Articles 16 through 18)
Allow the provision of support such as technological support, international cooperation support, clinical trials, etc. to those who intend to develop medical products for public health crises.
J. Exceptions in case of public health crisis (Article 19)
Authorize the Minister of Food and Drug Safety to allow the manufacturing and importation of domestically unlicensed medical products or the importation of medical products, etc. under development overseas without domestic approval for clinical trials at the request of the head of the relevant central administrative agency.
