Current Drug Regulatory Status of Advanced Drug Evaluation System in Korea

The pharmaceutical industry is a high-risk and high value-added industry, because the risk of failure in research and development is considerable. However, successful development will allow a company to get high returns. The market scale of the pharmaceutical industry has been increasing in the world and the Korean market is changing to focus on quality of life drugs owing to people’s increased income levels and changing lifestyles. Drug products are important for the prevention, diagnosis, and treatment of diseases, and the development of drug products has resulted in improved quality of life, health maintenance, and considerable benefits to individuals as well as the national economy. However, since drug products carry the risks of adverse reactions, they have to satisfy the two important criteria of safety and efficacy. Therefore, the Korean government has implemented a drug safety management system, including one for authorization of drug products. Recently, one of the most important issues in the Korean pharmaceutical industry has been the signing of the Korea-US FTA (Free Trade Agreement), which will promote rapid and widespread competition. The pharmaceutical industry will also face the challenges of a more competitive environment. For sustainable growth and development of the Korean pharmaceutical industry in this rapidly changing environment, the balanced harmonization of the industry’s strategic R&S efforts and the government’s positive policies is essential.