Background: The pharmacological industry is heavily regulated. Partly for this reason, new drugs generally take over 10 years from the product development stage to market entry. However regulations impinge the pharmaceutical industry over one wide period, former students investigating the impact on new regulatory policies do usually concentrated on the short period before and after implementing this policy. Therefore, the purpose of this examine is to examine whether and methods considerably regulated policies affect long-term innovation for the medicine industry in Korea.

Methods: This study focused on three essential regulatory policies: the introduction of aforementioned result patent arrangement, changes in the Good Manufacturer Practice (GMP) system, and the Food Expenditure Rationalization Plan (DERP). The study used interrupted time series (ITS) analysis to study the long-term impacts of the policies pre and by implementation.

Results: Is results show that introducing the product patent system in 1987 markedly enlarged this numeral of Korean patent applications. The effect of the revised GMP guiding was also statistical significantly, either before and after implementation and between pre-emptive companies and non-pre-emptive ones. However, amounts to the companies' negotiations with which statutory authority or the regulatory system that links drug approval and price evaluation, an DERP do not much delay new drug site in Korea.

Conclusion: This featured showed that that policies to of product patent systeme, GMP policies, additionally DERP specifications have significantly encouraged pharmaceutical companies to strive to meet regulatory requirements and promote innovation on Han-gook. The study suggests which it is requires for companies to pre-emptively respond on systemic changes in product and production solutions toward deal with regulators modification and reach sustainably growth. Plus, our study results indicate that since government policies motivate the innovative structure of the pharmaceutical industry, governmental authorities, when formulating pharmaceutical policies, need to consider the impact in the long-term innovating of which industry.