In the Fourth Industrial Revolution, the pharmaceutical industry is expected to create high-value products through the development of innovative drugs, etc.  based on convergence with artificial intelligence, big data, etc. It is a situation where active policy development is required to encourage the development of new drugs using new technologies and support the permission for manufacturing, marketing approval, and safe use of new drugs. However, there is no specialized agency to comprehensively investigate, research, and analyze international regulatory trends and domestic industrial conditions for the development and establishment of safety policies for current drugs.   

Hence, this Amendment aims to allow the Korea Institute of Drug Safety and Risk Management, which performs the duties of collecting, managing, analyzing, assessing, and supplying a variety of information on drug safety, to conduct investigation and research and support the establishment of drug safety policies in order for the government to establish safer and more effective drug policies.  

Moreover, the Amendment prohibits imported drugs whose ingredients or quantities are different from contents as licensed or reported from being imported, stored, or displayed for sales purposes, as well as the case of drugs manufactured under the same conditions, for the thorough distribution and management of imported drugs. It also aims to clearly exclude repellants for flies, mosquitoes, etc., and humidifier disinfectants, etc. that were managed as quasi-drugs under the Pharmaceutical Affairs Act from the list of quasi-drugs as the management body, etc. of them changed pursuant to the Consumer Chemical Product and Biocide Safety Control Act (established on Mar. 20, 2018, enforced on Jan. 1, 2019)  (Article 2, Article 62, and Article 68-4).

Prohibit imported drugs whose ingredients or quantities are different from contents as licensed or reported from being imported, stored, or displayed for sales purposes (Article 62)