The Ministry of Food and Drug Safety has signed a mutual recognition agreement (MRA) with Singapore's Health Sciences Authority (HSA) to recognize the results of Good Manufacturing Practice (GMP) surveys of pharmaceutical manufacturing facilities between the two countries.

Minister of Food and Drug Safety Oh Yu-kyoung (right) and Singapore’s Health Sciences Authority Director General Choong May Ling signed the Korea-Singapore Pharmaceutical GMP Mutual Recognition Agreement at the MFDS on Monday.
Minister of Food and Drug Safety Oh Yu-kyoung (right) and Singapore’s Health Sciences Authority Director General Choong May Ling signed the Korea-Singapore Pharmaceutical GMP Mutual Recognition Agreement at the MFDS on Monday.

Minister of Food and Drug Safety Oh Yu-kyoung and HSA Director General Choong May Ling signed the mutual agreement. Health Sciences Authority is the government agency responsible for licenses and safety management of medical products in Singapore, including drugs and medical devices. The agreement will officially take effect in May.

On behalf of their governments, Oh and Choong signed a memorandum of exchange to add “GMP for Pharmaceuticals” to the sectoral annex of the Korea-Singapore FTA, agreeing that both countries would equally recognize the results of GMP conformity assessments conducted by the other government.

Under the agreement, Korean companies can use the GMP conformity certificate issued by the MFDS when exporting drugs to Singapore, which will shorten the approval period and reduce costs, the ministry said.

"The signing of this agreement is based on the trust that has been built since we began discussions in earnest in 2019, confirming the equivalence of GMP regulatory systems in both PIC/S (Pharmaceutical Inspection Cooperation/Scheme) countries," Minister Oh said. "It will help Korean pharmaceutical companies enter the Singapore market and improve the bilateral drug supply system by reducing unnecessary costs and administrative burdens for both governments in approving imported drugs."

Director General Choong said, "This will help build trust between the two countries, leading to increased trade and investment and having a positive impact on the development of the pharmaceutical industry and the environment while ensuring the safety of consumers in both countries."

Singapore is an advanced pharmaceutical GMP country in the region, with its geographical location at the confluence of the Pacific and Indian Oceans, excellent research talent, and high potential, making it a base for many multinational pharmaceutical companies to enter the Asian market.

Korea’s medical product exports to Singapore increased by 530.43 percent from $23 million in 2019 to $145 million in 2022. Singapore's share in the Korean pharmaceutical exports to the 10 ASEAN countries also expanded from 5 percent to 22 percent.

"We expect this agreement to serve as an opportunity for Korea's GMP management system to be recognized internationally, expand opportunities for drug exports to ASEAN countries, and serve as a springboard for mutual recognition agreements with other countries in ASEAN,” the ministry said. “We will continue actively supporting Korean pharmaceutical companies to expand overseas, including in the ASEAN region."

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