Pharmaceuticals

A draft regulation of "Bill on public health response medical product and innovative new drug development support" (24 page(s), in Korean)

The Ministry of Food and Drug Safety of the Republic of Korea is proposing the draft regulation on the "Bill on public health response medical product and innovative new drug development support". The main contents are:

1) The purpose is to promote the development and supply of pharmaceutical for public health crisis response and new medicines, ultimately, to protect the health of the people and to contribute to the improvement of the quality of life in order to lead reinforced public nature and innovation growth in the pharmaceutical industry (Article 1 of the Proposal).

2) Republic of Korea shall endeavour to ensure smooth supply of said pharmaceutical by supporting and promoting the development of pharmaceutical for public health crisis response and new drug. The Minister of Food and Drug Safety shall take measures such as establishing a relevant system and training human resources in order to develop a method which facilitate quick prediction, evaluation and judgement quality, safety and efficacy of pharmaceutical for public health crisis response and new medicine (Article 3 of the Proposal).

3) The Safety Management Committee for pharmaceutical for public health crisis response and new drug shall be established under the Ministry of Food and Drug Safety to deliberate and consult the development of safety control systems and systems, development support and promotion, designation and cancellation of designation, approval and cancellation of approval and transfer and acquisition of approval for pharmaceutical for public health crisis response (Article 5 of the Proposed).

4) Designation system for pharmaceutical for public health crisis response or new medicine will be introduced by creating designation requirements and process for the pharmaceutical and the innovative new drug that can be provided administrative support such as simplification of document submission for preemptive review, application approval and frequent accompanying review (Article 6 and 7 of the proposal).

5) The Minister of Food and Drug Safety shall provide administrative support, such as preemptive review and frequent accompanying review where an application for approval is filed for the designated pharmaceutical for public health crisis response or new drug (Article 8 and 9 of the proposal).

6) For the innovative medicine whose forms and purpose of the therapeutic search clinical trials are similar to those of therapeutic confirmation clinical trials among pharmaceuticals and innovative new drug that cannot be conducted clinical trials for human due to ethical reasons of pharmaceutical for public health crisis response or new drug (Articles 10 and 11), submission documents for application for approval shall be replaced with another ones and simplified.

7) Where Minister of Food and Drug Safety gives product approval for pharmaceutical for public health crisis response or innovative new drug, he/she shall evaluate the impact of the drug on patient treatment and the comprehensive therapeutic value by taking into account the safety and efficacy of the drug and publish it on the Internet website (Article 12 of the proposal).

8) The Minister of Food and Drug Safety shall provide the developers with relevant domestic and international information or support international exchange and joint international research to cooperate with international organizations, who promote the development of pharmaceutical for public health crisis response or innovative new drug (Article 14 of the Proposal).

9) Where a person who has been designated as pharmaceutical for public health crisis response or innovative new drug intends to conduct a clinical trial for said pharmaceutical, Minister of Food and Drug Safety shall support preparation of a clinical trial plan, recruitment of clinical trial participants, training for persons engaged in clinical trials and the implementation of international joint clinical trials (Section 15).

10) A person who has obtained a product approval for pharmaceutical for public health crisis response are required to conduct a survey on the safety use and the results of use of the drug and quarterly report it to the Minister of Food and Drug Safety. The minister may order additional measures for safe use following the review of the report, if these measures are not implemented, the minister my order to recall and abandon the drug (Article 16 of the proposal).

11) It enables a person who has obtained a product approval for pharmaceutical for public health crisis response or innovative new drug to support the patient treatment such as providing the patient with pharmaceutical free of charge, if necessary, request the Minister of Food and Drug Safety to support it (Article 17 of the proposal).

12) Where the medical device combined with pharmaceutical for public health crisis response or innovative new drug or approval is required in accordance with Medical Device Act as it falls within the medical device for diagnosing the indication of pharmaceutical for public health crisis response or innovative new drug, under this Act, the submitted documents to obtain product approval for pharmaceutical for public health crisis response or innovative new drug shall be utilized for the purpose of approval of medical device (Article 18 of the proposal).

13) It enables a person who has obtained a product approval for pharmaceutical for public health crisis response or innovative new drug, importer, wholesaler, medical institution organizer to report the adverse events, which suspected of said pharmaceutical, such as illness, disability and death, to the director of the Korea Institute of Drug Safety & Risk Management and the director shall it to Minister of Food and Drug Safety (Article 19 of the proposal).

14) Transfer and acquisition for pharmaceutical for public health crisis response or innovative new drug shall be deliberated by the Safety Committee on pharmaceutical for public health crisis response and new drug (Article 20 of the proposal).