Pharmaceuticals, Quasi-drug

The draft regulation of "Special bill on emergency use and development support of public health response medical product such as infectious diseases" (23 page(s), in Korean)

The Ministry of Food and Drug Safety of the Republic of Korea is proposing the draft regulation on the "Special bill on emergency use and development support of public health response medical product such as infectious diseases". The main contents are:

 1) Designation system of public health crisis response medical product such as infectious disease shall be introduced in order to respond the diseases caused by the use of infectious disease and biochemical weapons. Materials to be submitted, designation requirements and designation procedures for designation application shall be specified (Article 5 of Draft).

 2) The bill allows the person who intends to develop public health crisis response medical product such as infectious disease to provide necessary technical support, human resources, international cooperation, and clinical trial (Article 6 and 7 of Draft).

 3) 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 (Article 8 of Draft).

 4) The review for the medical products shall be prioritized where the product license for the public health crisis response medical products such as infectious disease is applied (Draft Article 9).

 5) The manufacturing/marketing product license may be granted with one more conditions such as submission of additional clinical trial data where manufacturing/marketing product license for public health crisis response medical products such as an infectious disease is applied (Article 10 of Draft).

 6) It deems that public health crisis response medical product such as infectious disease that have been granted conditional manufacturing/marketing product license is designated as national essential drug (Draft Article 11).

 7) The Minister of Food and Drug Safety shall evaluate matters such as the impact on the treatment of patient, safety and efficacy and publish the result of them on the web site where the manufacturing/marketing product license for public health crisis response medical product such as infectious disease is granted (Article 12 of Draft).

8) A person who has obtained manufacturing/marketing product license for public health crisis response medical product such as said infectious disease shall carry out investigation on safety measure and medical product use-results and report the result to the Minister of Food and Drug Safety (Article 13 of Draft).

9) A person who has obtained manufacturing/marketing product license for public health crisis response medical product such as infectious disease may pursue the treatment support project including providing medicines for free with those who are in need of them (Article 14 of Draft).

 10) The Minister of Food and Drug Safety may grant permission for the manufacturing and importing of unapproved medical product or importing of the medicines in the overseas development without clinical trial approval in Korea to respond the public health crisis as the request of head of the central administrative agency and the Minister of Health and Welfare may request the Minister of Food and Drug Safety to extend the expiration date of the medicine stockpile (Article 15 of Draft).

 11) The manufacturer or importer of medicine may apply emergency special permission to the Minister of Food and Drug Safety in order to promptly respond to national emergencies such as the spread of diseases that may seriously affect the lives and health of people. The Minister may grant restrictive approval where the Minister deems that the submitted materials are appropriate after deliberation by the Central Pharmaceutical Affairs Council under the submission of data (Article 16 of Draft).

 12) The Minister of Food and Drug Safety may grant the unapproved medical devices to be manufactured, imported, stored and displayed as the request of the head of the relevant central governmental agency in order to appropriately respond to national emergencies (Article 17 of Draft).

13) The materials submitted to receive the public health crisis response medical product such as infectious disease may be requested the Minister of Food and Drug Safety to be used for the said medical device review where a permission for a medical device that is combined with public health crisis response medical product such as infectious disease is granted (Article 19 of Draft).