KR Südkorea
  • 30 - Pharmazeutische Erzeugnisse


Enforcement Rule of Act on Encouragement of Development and Emergency Distribution of Medical Countermeasures for Public Health Emergency (59 page(s), in Korean)

1) Establishment of Committee for Safety Management and Circulation of Medical Countermeasures (MCs) for Public Health Emergency (PHE) (Article 3 of the Draft)

Tenure of the commissioner (2 year) of the committee and the ground such as mental and physical disability to dismiss the committee, which was delegated from the decree, has been prepared

2) Expulsion/avoidance/evasion of committee commissioner (Article 4 of the draft)

If it is not available for a commissioner to fairly deliberate and vote, it is possible to expel, avoid and evade the commissioner

3) Operation of committee (Article 5 of the draft)

Detailed guidance concerning operation such as role of the chair, convocation of the committee, reproposal, decision criteria and consultation has been established

4) Composition of subcommittee (Article 6 of the draft)

For more professional deliberation, subcommittee for safety management and circulation have been established

5) Designation of preliminary MCs for PHE (Article 9 of the draft)

Designation of preliminary MCs for PHE form, application method, issuance of designation and designation notification method, etc. have been specified

6) Procedure and method of priority review, rolling review (Article 10 and 11 of the draft)

Review on preliminary MCs for PHE shall be conducted within 40 days and document submission and authorization form for rolling review has been specified

7) Application for conditional marketing authorization (Article 13 of the draft)

For application for conditional marketing authorization of preliminary MCs for PHE, data to be submitted for each medical product shall be clearly defined

8) Procedure and method of Emergency Use Authorization (EUA) (Article 14 of the draft)

Required procedure, date to be submitted by manufacturer and processing procedure for EUA shall be specified

9) Procedure and method of safety use (Article 15 of the draft)

Procedure on Type and reporting of safety use and report analysis of medical products obtained conditional marketing authorization shall be prepared

10) Reporting adverse event (Article 16 of the draft)

Procedure on reporting on adverse event for medical products granted conditional marketing authorization to Korea Institute of Drug Safety & Risk Management (KIDS) and National Institute of Medical Device Safety Information (NIDS) shall be prepared

11) Establishment of traceability and tracking system (Article 17 of the draft)

Item and timeline required for traceability and tracking system shall be specified

12) Designation process and method of MCs for PHE (Article 19 of the draft)

Designation process, method, issuance of designation form and publication on the website of MCs for PHE shall be specified.

13) Scope‧ method and process for investigation (Article 20 of the draft)

Investigation scope of medical products, notice for investigation target and qualification for investigator

14) Establishment of standards of administrative disposition (Article 21 of the draft)

Standards of administrative disposition for violation of this Act shall be established