1. Reasons for Amendment and Major Provisions
A. Improve the submission deadline for risk management plans and prescribe grounds for modification orders, etc. (Articles 4 and 8)
Although current provisions require the submission of a risk management plan when applying for a permission by item of drugs, the amendment allows the submission of an outline of the risk management plan when it is difficult to submit the plan upon applying for a permission by item due to matters necessary for risk management not having been determined. It also prescribes a procedure where matters for which the Minister of Food and Drug Safety has ordered a modification to manufacturing and distribution or import permission (notification) by item before a certain deadline as a result of a safety and effectiveness data assessment in accordance with the implementation of a risk management plan shall be construed as having been granted permission for modification (or as having filed a notification of modification).
B. Simplify data submission requirements for approvals for use of investigational products for treatment purposes, prescribe grounds for obligations of providers of investigational products, etc. (Article 28)
Streamline overlapping or unnecessary documents for approvals for the use of investigational products for treatment purposes in patients whose lives are in immediate danger or for whom there are no alternative treatments, thereby increasing the availability of the system to patients who need to use investigational products. Enhance safety management of use for treatment purposes by making providers of investigational products responsible for managing the history of, and safety information on, use for treatment purposes.
C. Prescribe reporting procedures, templates, etc. for safety information on investigational products (Article 30)
Ensure the safety of clinical trial subjects and enhance the reliability of clinical trials by requiring any person whose clinical trial protocol has been approved to report to the Minister of Food and Drug Safety on safety information assessment results of the investigational product each year.
D. Specify drugs whose purchase through illegal channels may be punishable (Article 62-2)
Specify drugs containing etomidate as prescription drugs that shall not be acquired by any drug consumer from any person who is not authorized to distribute drugs.
E. Modify the import system for source plasma, etc. (attached Table 5)
Modify the import system for source plasma used as raw materials for plasma derived products, and clearly prescribe grounds on which the Korean Red Cross, which provides source plasma under raw material supply contracts with drug manufacturers, may determine the suitability for use on a quarterly basis.
F. Prescribe penalty criteria against national lot release approvals obtained by fraud or other improper means (attached Table 8)
Prescribe penalty criteria stipulating that where a national lot release approval has been obtained by fraud or other improper means, the corresponding permission by item shall be revoked. Specify penalty criteria for persons who fail to report safety information on investigational products, and for persons who fail to submit a risk management plan at least one month prior to market distribution after submitting an outline of the risk management plan.
