With the signing of the “Treaty of Ganghwa” with Japan, Joseon dynasty opened its doors to Western countries. Subsequently, Western medicine and pharmacology were introduced into the country, marking the beginning of the modern pharmaceutical industry in Korea.

When the nation's name was changed from the “Chosun Dynasty” to the “Greater Korean Empire”, Korea's first pharmaceutical company, Dong Wha Pharmacy (now Dong Wha Pharm), was established, and the first new drug, “Whal Myung Su”, was developed.

After Korea was liberated from Japan, a large quantity of relief medicines was brought into the country from Western nations.

Starting in the mid-1950s, the government implemented an import substitution industrialization policy. From the late 1950s to the early 1960s, the foundation for the modern pharmaceutical industry was laid with the aid of funds from the U.S. International Cooperation Administration (ICA).

Since the enactment and proclamation of the 『Foreign Capital Inducement Act』 in January 1960, technology partnerships and joint ventures became active. In 1964, Handok

Handok Pharmaceuticals and Germany's Hoechst established the first joint venture in Korea.

In line with international regulatory harmonization trends, including WHO recommendations, the South Korean government established GMP standards, marking a significant improvement in pharmaceutical quality.

With the introduction of the “Patent Law”, research and development of pharmaceuticals by domestic pharmaceutical companies in South Korea became more active. As a result, in July 1999, the first domestically developed new drug for stomach cancer treatment, "Sunpla®" was born, and in April 2003, the first domestically developed antibiotic, "Factive," received FDA approval for the first time. With these developments, South Korea joined the ranks of the world's top ten countries in new drug development.

Since the mid-1990s, the government has instituted reform measures such as establishing ethical guidelines and fair competition regulations in the pharmaceutical industry to promote a fair competitive environment. As a result, the foundation for ethical management in the pharmaceutical industry has been established.

The pharmaceutical division implemented by South Korea had a significant impact on the pharmaceutical industry, including the expansion of the prescription pharmacy market, the slowdown in growth of generic drugs, and changes in drug usage quantity. Such shifts in the pharmaceutical market landscape have spurred innovation in research and development of new products, production management, and marketing strategies.

Since the mid-2000s, under the "Advancement of GMP (Good Manufacturing Practices), a standard for excellent pharmaceutical manufacturing and quality management," project, efforts have been made to establish production facilities that comply with the cGMP (current Good Manufacturing Practice) standards applied by advanced countries such as the United States. Additionally, companies have gradually begun to enhance their R&D capabilities and strive to secure competitiveness in production and quality management at the level of advanced countries.

After the conclusion of the South Korea-US Free Trade Agreement (FTA) in 2007, followed by FTAs with the EU and China, the domestic pharmaceutical industry has actively sought opportunities for global market expansion in line with shifts in international trade paradigms. There has been a growing recognition within the pharmaceutical sector that overseas market entry, through initiatives such as new drug development, is essential beyond the domestic market. This perception has led to increased investment in Research and Development (R&D). As a result, the proportion of R&D investment to revenue has surged from the previous 3% range to 6-7%.

Korea abolished the stepwise drug pricing system, which had implemented differential prices for pharmaceuticals with identical ingredients based on their order of listing in health insurance coverage. Instead, a new method called the "overall drug price reduction" was introduced. This new approach reduced the upper limit price from 68%-80% of the original price of patent-expired drugs to 53.55%. As a result of this reform, there was an average 14% decrease in overall pharmaceutical prices, amounting to a total reduction of 1.7 trillion won. This change posed challenges for pharmaceutical companies, leading to decreased revenues. Additionally, under this new system, companies are encouraged to compete freely at prices below the established threshold.

A total of 43 companies were selected by the Ministry of Health and Welfare as 『innovative pharmaceutical companies』, including 2 large pharmaceutical companies, 10 medium and small-sized pharmaceutical companies, 6 bio-venture companies, and 1 multinational pharmaceutical company. These innovative pharmaceutical companies are faithfully fulfilling their roles as industry leaders in new drug research and development, global expansion, and ethical management.

Korea(MFDS) joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which internationally recognized the quality and production management capabilities of Korean pharmaceuticals.

Following the signing of the Korea-US FTA, the Medicinal Product Approval-Patent Linkage System was implemented in March 2015 (with a three-year grace period after the enactment of the Korea-US FTA in 2012). Under this system, priority sales item approval is granted to the first generic drug to succeed in patent challenges and suspend sales permits for generics for three years.

Korea(MFDS) has become a Regulatory Member of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), indicating that the regulatory standards of Korea's pharmaceutical industry are equivalent to those of advanced pharmaceutical markets such as the USA and Europe.

Following the signing of the Korea-US FTA, the Medicinal Product Approval-Patent Linkage System was implemented in March 2015 (with a three-year grace period after the enactment of the Korea-US FTA in 2012). Under this system, priority sales item approval is granted to the first generic drug to succeed in patent challenges and suspend sales permits for generics for three years.

Korea(MFDS) was elected as a member of ICH Management Committee. As a member, MFDS can participate in preparing guideline based on each regulatory authority’s comments after further discussions by the ICH Working Groups which consist of regulatory authorities and industries. The MFDS engaged in 16 areas of the 34 existing ICH Working Groups.

The bio-health industry, alongside system semiconductors and future automobiles, has been designated as one of the 'Big Three' industries for Korea to nurture in the future.

Korea(MFDS) was listed as the seventh country on the EU White-list, affirming the excellence of Korea's pharmaceutical manufacturing and quality control standards. Being on the EU White-list exempts companies from listed countries from the requirement of providing written confirmation of API compliance with EU GMP standards.

Korea(MFDS) and Switzerland(Swissmedic) signed a GMP Mutual Recognition Agreement(MRA), designed to facilitate the trade of medicinal products between the two countries and reduce the regulatory workload for authorization.

The World Health Organization(WHO) designated Korea as a 'Global Biomanufacturing Workforce Training Hub'.

The government announced the 'Third Five-Year Comprehensive Plan' for the development and support of the biopharmaceutical industry. Under this plan, the government will steadily increase public-private joint R&D investments, develop and support next-generation technologies, promote open innovation, and provide focused support for R&D in AI and big data-based development of new medicines.

Korea(MFDS) has been listed among the WHO Listed Authorities (WLA), demonstrating that Korea's regulatory system and capabilities have gained international recognition. This status is expected to provide Korea with favorable conditions for international pharmaceutical procurement and expand its exports.

The Korean government has established the 'Bio-Health Innovation Commission', a public-private joint control tower, to oversee and coordinate pharmaceutical and biotech development policies that were previously scattered across various ministries. This initiative aims to elevate Korea to a global bio-health hub and secure a substantial competitive advantage in the bio-health industry.