[Press Release, July 30, 2020 / unofficial translation] Korea-Singapore, taking the first step toward the mutual recognition on pharmaceutical GMP - Initiate the pilot project of recognizing inspection results on pharmaceutical GMP of manufacturing sites between Korea and Singapore from August 1st - □ The Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-Kyung) and Health Sciences Authority (HSA) of the Republic of Singapore initiate the pilot project ofrecognizing inspection results on pharmaceutical GMP of manufacturing sites between Korea and Singapore. * Health Sciences Authority, HSA: The national authority of Singapore regulating health products; managing the national blood bank, transfusion medicines and forensic medicine experties; and providing critical forensic and analytical laboratory services. ○ Accordingly, both countries assess GMP certificates and pharmaceutical GMP inspection reports issued by the other country instead of conducting on-site inspections. * Good Manufacturing Practice (GMP): A system for manufacturers to ensure that pharmaceuticals are consistently produced and controlled according to approved conditions and quality standards. □ As the first step toward the signing of the Mutual Recognition Agreement, the pilot project aims to assess whether both countries’ GMP regulations and quality systems are equivalent and comply with the international standards. ○The scope of products includes all pharmaceuticals for human use, such as chemical products, biopharmaceuticals, and herbal medicinal products, and the pilot project applies to pre-approval and routine GMP assessments. □ The market share of Korea’s pharmaceuticals in the ASEAN countries has been relatively low. However, in recent 5 years (2014~2018), the annual export has shown an increase of 10.5% on average, which is expected to grow further. ※ The size of the ASEAN pharmaceutical market : 25.9 billion dollars (About 30 trillion won) in 2018 ※ The amount of export of pharmaceuticals to ASEAN : 314.8 million dollars in 2014 → \465.8 million dollars (Increased by 48%) in 2018 □ The Minister Lee stated, “The Mutual Recognition Agreement (MRA) with Singapore,a leading ASEAN country in pharmaceuticals would contribute to minimizing the approval process, etc., which helps facilitate the entry of Korean pharmaceutical products into the ASEAN member states. ○ Also, she added, “the MFDS will continue to expand the mutual cooperation with other leading countries in order to help Korean pharmaceutical and biopharmaceutical manufacturers enter the overseas market.