(1) Reasons for Proposal
The Pharmaceutical Affairs Act was amended (Act no. 15891; promulgated on December 11, 2018) to strengthen the safety management of imported drugs, etc., by allowing the registration and investigation of overseas production facilities of the relevant imported drugs, etc.; protect the health rights of clinical trial subjects by obligating clinical trial sponsors to purchase insurance; and investigate unlawful drug sales using information and communications networks by allowing data to be requested from providers of information and communications services. Accordingly, this Amendment prescribes detailed matters concerning the registration procedure for and investigations of overseas production facilities; modifies provisions concerning the obligations of persons intending to conduct a clinical trial; and prescribes procedural matters, etc., for requesting data from providers of information and communications services.
  It also allows preventive measures to be taken promptly by further subcategorizing matters concerning the timely reporting of safety information for post-marketing safety control of drugs, and otherwise addresses and improves upon a number of weaknesses that have emerged from the operation of the current system.

(2) Major Provisions
A. Modify restrictions on the number of times a healthy person may participate in clinical trials (Article 30)
1) The former “Rules on the Safety of Drugs, etc.” restricted the number of times a healthy person could participate in clinical trials to four times a year, but the provision has been transferred to the amended Pharmaceutical Affairs Act (Act no. 15891; promulgated on December 11, 2018) and modified to allow participation only two times a year.
2) This adjustment to the number of times a healthy person may participate in clinical trials (from four to two times a year) is expected to protect the health rights of clinical trial subjects and enhance the reliability of the results of clinical trials.
B. Clarify provisions on modified designation of clinical trial education providers (Article 38-3)
1) Clinical trial education providers that intend to modify designated matters* are required to obtain a modified designation from the Minister of Food and Drug Safety. However, even simple modifications such as a change of address due to a reorganization of administrative districts entail fees and require a processing period of 30 days, making it difficult to provide clinical trial education in a timely manner.
* Designated matters: Name of the institution, head of the education provider, address, curriculum, designation conditions
2) Accordingly, the Amendment promotes timely provision of clinical trial education by prescribing that among the designated matters of a clinical trial education provider, only the address (excluding changes due to a reorganization of administrative districts) and curriculum (including designation requirements) shall be subject to modified designation while the other matters shall only require a modification report.
C. Prescribe detailed procedures concerning the registration and investigations of overseas production facilities of imported drugs, etc. (Articles 56-3 to 56-7)
1) The amended Pharmaceutical Affairs Act obligates importers to register the overseas production facilities of imported drugs, etc., and prescribes that where it is necessary to take measures concerning the safety of drugs, the Minister of Food and Drug Safety may conduct an on-site investigation through which he or she may suspend imports, issue an inspection order for quality, etc., request correction, etc.
2) Accordingly, this Amendment ensures the completeness of the Pharmaceutical Affairs Act by prescribing matters delegated by the Act to the Ordinance of the Prime Minister, such as registration procedures for overseas production facilities, scope of change registrations and change reports, procedure and method of on-site investigations, and matters concerning measures such as import suspension, etc., and their revocation. By incorporating the registration and on-site investigation systems for overseas production facilities into pharmaceutical affairs laws to strengthen safety management of imported drugs, the Amendment is expected to promote the successful implementation of the said systems.
D. Prescribe procedures for submitting data on unlawful drug sales (Article 71-2)
1) The amended Pharmaceutical Affairs Act prescribes grounds on which the Minister of Food and Drug Safety may request providers of information and communications services to submit relevant data when he or she intends to conduct an investigation of unlawful drug sales using information and communications networks.
2) Accordingly, the Amendment allows the name, address, contact details, and other information and transaction details concerning persons who have engaged in unlawful drug sales to be requested from providers of information and communications services, and prescribes methods for sending requests or responses. This is expected to enable the eradication of violations concerning unlawful drug sales.
E. Prescribe procedures concerning the formulation of master plans and action plans on drug safety management (Article 102-6)
1) The amended Pharmaceutical Affairs Act stipulates that the Minister of Food and Drug Safety shall formulate master plans and action plans on drug safety management.
2) Accordingly, the Amendment specifies the content of the five-yearly master plans and prescribes the content and procedures of yearly action plans, thereby aiming to provide plans and the basis therefor to enable the Ministry of Food and Drug Safety to stably fulfill its role as a control tower of drug safety management.
F. Prescribe procedures for the establishment and operation of an integrated drug information system (Article 102-7)
1) The amended Pharmaceutical Affairs Act requires the Minister of Food and Drug Safety to establish and operate an integrated drug information system to comprehensively manage affairs necessary for the full life cycle safety management of drugs, etc.
2) Accordingly, this Amendment enables stable system establishment and operation by prescribing matters concerning the operation of the integrated drug information system, outsourced management, council for collecting feedback, etc. It is expected to allow the establishment of a new platform for drug safety management.
G. Clarify matters concerning site management organizations (attached Table 4)
1) Current provisions provide for site management organizations from which, in accordance with an agreement with the head of an institute for clinical trials, a professional clinical research coordinator with experience and knowledge in clinical trials is sent to the institute for clinical trials to perform duties delegated under the responsibility of the principal investigator. However, concerns have been raised that provisions allowing clinical research coordinators to be “placed” may be in violation of the Act on the Protection, etc. of Temporary Agency Workers.
2) Accordingly, the Amendment modifies the act of “placing” clinical research coordinators in accordance with actual cases, thereby aiming to enable site management organizations to actively support the timely and professional implementation of clinical trials and contribute to job creation.
H. Modify post-marketing safety control regulations for drugs (attached Table 4-3)
1) A post-marketing safety control system for drugs is being operated to establish a rapid response system through a quick gathering of safety information in Korea and abroad when the side effects of drugs arise. However, critics point out that rapid response is difficult due to the limited scope of safety information subject to reporting.
2) Accordingly, the Amendment prescribes a safe post-marketing control system for drugs by stipulating that when there is significant offshore information equivalent to a sales suspension or recall by a foreign government, actions taken by manufacturers, sellers, etc., and any significant safety information associated with deaths, etc., shall also be subject to compulsory reporting.