(1) Reasons for Proposal

This amendment aims to prescribe matters delegated by the Act and matters required for enforcement, such as establishing standards for administrative disposition and to improve and supplement some of the shortcomings that have emerged from the operation of the current system, such as rationalizing the reporting deadline of the drug substance registration system, as the Pharmaceutical Affairs Act has been revised (Act No. 17208; promulgated on April 7, 2020; enforced on April 7, 2020) to allow the cancellation of approval, etc., in the case of receiving approval or notification for manufacturing, importing, and marketing of drugs, etc. deceitfully or otherwise fraudulently.

(2) Major Provisions

A. Establish, etc. administrative disposition standards for pharmaceutical manufacturers, etc. (attached Table 1) 

Aim to establish administrative disposition standards for receiving approval or notification for manufacturing, importing, and marketing, a protocol of clinical trials, and a national lot release of drugs, etc. deceitfully or otherwise fraudulently. Aim to improve detailed administrative disposition standards for failing to prepare or preparing deceitfully a test/manufacturing direction or records 

B. Change the deadline for reporting changes in drug substance registration matters (Article 17) 

Aim to increase the efficiency of business processing by converting the deadline for reporting changes in drug substance registration matters, which was set for January 31 of each year for all drug substances subject to registration, into reporting changes for one year based on the end of the previous month of the first registration date of the drug substance

C. Establish a basis for exemption from testing by importers for national essential drugs (Article 60) 

Aim to minimize the treatment gap of domestic patients by allowing importers to replace the test results of the imports with the original manufacturer's test results to support the timely supply of national essential drugs, if there is a risk of disruption in patient treatment when the supply of national essential drugs, such as orphan drugs, is discontinued because there is no alternative domestic drug

D. Shorten the enforcement period for expanding the scope of application for pharmaceutical manufacturing and quality control standards (Articles 4 and 48) 

Aim to strengthen the safety and quality control of drugs by changing the enforcement period of the revised provision requiring the application of pharmaceutical manufacturing and quality control standards for “products (disinfectants, etc.) not directly applied to the human body“ that was pre-announced on January 18, 2019, from two years after the promulgation to one year after the promulgation and shortening the period of transitional measures for the existing pharmaceutical manufacturers from two years after the promulgation to one year after the promulgation.