South Korea - Proposing regulation on the act on special cases concerning promoting the development of public health crisis response medical products and supplying medical products for emergency response The Ministry of Food and Drug Safety of the Republic of Korea is proposing the draft regulation on the "Act on Special Cases Concerning Promoting the Development of Public Health Crisis Response Medical Products and Supplying Medical Products for Emergency Response". The main contents are: 1) Introduction of designation system for public health crisis response medical products (Article 6 of Draft)
Designation system for public health crisis response medical product shall be introduced to promptly support rapid development of public health crisis response medical products and materials to be submitted, designation requirements and designation procedures for designation application shall be specified. 2) Priority review system of public health crisis response medical products (Article 7 of Draft)
Rapid availability of public health crisis response medical products shall be ensured by prioritizing investigation for the medical products where the product license for the public health crisis response medical products is applied or permission for clinical trial investigation protocol is applied. 3) Situational frequent review for public health crisis response medical products (Article 8 of Draft)
In order to shorten the review period for product license of public health crisis response medical products, the results of clinical trials shall be submitted for each development process and they shall be reviewed in advance. 4) Conditional product license for public health crisis response medical products (Article 9 of Draft)
For the application for the product license of product license of public health crisis response medical products, the requirements for the application shall be replaced with other ones or streamlined, but conditional product license shall be conducted where the clinical trials for the humans cannot be performed due to ethical reasons or the medicine whose navigational clinical trial format (phase 2) and purpose are similar to therapeutic validation clinical trials (phase 3). 5) Safety measures for public health crisis response medical products (Article 11 of Draft)
A person who has obtained the product license for public health crisis response medical products shall carry out safety measure and medical product use-results surveillance and report them. The Minister of Food and Drug Safety may order additional measures related to safety use, if necessary, based on the report results. 6) Adverse event reporting system of public health crisis response medical products (Article 12 of Draft)
If a person who has obtained the product license for public health crisis response medical products recognizes the examples of safety and efficacy, he/she shall report it to the president of Korea Institute of Drug Safety and Risk Management (KIDS). The Minister of Food and Drug Safety who was reported about the analysis result from the president of KIDS shall determine whether to continue to use the medical product where it deems that there is serious risk on it. 7) Tracking investigation and usage history registration of public health crisis response medical products (Article 13 of Draft)
If it is recognized that it is necessary to confirm whether adverse event occur over a certain period after the use of public health crisis response medical products, it may be designated for tracking investigation and performed it, and necessary measures for public health may be taken according to the result of the investigation. 8) Support project for the use of public health crisis response medical products (Article 14 of the draft)
A person who has obtained product license of public health crisis response medical products may pursue the project including providing medical products for free with those who are in need of them. 9) Support development of public health crisis response medical products (Articles 16 to 18 of Draft)
For the person who intends to develop public health crisis response medical products, technical support, international cooperation support, clinical trials shall be provided. 10) Special cases concerning public health crisis (Article 19 of Draft)
The Minister of Food and Drug Safety may grant permission for the manufacturing and importing of unapproved medical product or importing of the overseas medical product development without clinical trial approval in Korea to respond the public health crisis as the request of head of the central administrative agency. 11) Extension of expiration date of national medicine stockpile (Article 20 of Draft)
The head of the central administrative agency may request the Minister of the Food and Drug Safety to extend expiration date of national medicine stockpile where the head deems that it is necessary to extend the expiration date of the medicine stockpile or quasi-drugs in accordance with legislation concerned. 12) Issuance command on urgent production and import of permitted medical products (Article 21 of Draft)
The Minister of Food and Drug Safety may issue a command on production adjustment and import control and import control of permitted medical products during the public health crisis. Furthermore, the Minister may request the head of the central administrative agency to take necessary measure where it is necessary to have consultation between countries caused by shortage of raw materials countries. 13) Distribution management of medical products (Article 22 of Draft)
The Minister of Food and Drug Safety may take measure including designation of distributor and setting market condition of medical products in the event of public health crisis, if necessary, the Minister may request the head of the central administrative agency to cooperate. 14) Construction of information system for public health crisis response medical products (Article 23 of draft) The Minister of Food and Drug Safety may build and operate information system related to supply management of medical products in order to efficiently promote distribution management. 15) Conducting field survey for Public Health Crisis Response Medical Products (Article 25 of Draft)
The Minister of Food and Drug Safety may investigate manufacturing, importing and utilization of Public Health Crisis Response Medical Product in order to ensure the quality and safety of public health crisis response medical products and may request the person who has obtained the product license of the said product to submit the relevant data and give his/her opinion. 16) Preparation of ground for cancellation of manufacturing approval and suspension of business (Article 26 of Draft)
If a person who has obtained product license for Public Health Crisis Response Medical Product violates the obligation stipulated by this Act, the established ground allows to revoke the product license for the medical product or order the suspension of manufacturing, importing, and marketing within a year. 17) Preparation of ground for fine disposition (Article 27 of Draft)
The established ground which allows to impose a fine of 1 billion won substituting for disposition of business suspension where there is concern that it is likely to inconvenience the person who uses Public Health Crisis Response Medical Product and harm public interest according to Article 26. 18) Preparation of ground for penalty (from Articles 30 to 32 of Draft)
The established ground allows to punish the person who violated the Act including the person who has obtained the product license for the Public Health Crisis Response Medical Product by false or other illegal methods according to the penal regulations. 19) Preparation of grounds for fines (Article 34 of Draft)
The established ground allows to punish the person who breached the reporting and registration obligation including the person who has not reported the results of investigations such as safety measure. Products covered :Pharmaceuticals, Quasi-drug, Medical devices Proposed date of adoption:To be determined Proposed date of entry into force:To be determined Final date for comments:60 days from notification | 
.gif)
