Abstract
Background: For Korean pharmaceutical industry to continue to grow, it is requisite to enter the global markets of developed countries. However, the export volume has fallen short of 10% of the gross sales and the industry has only recently warming up to prepare the globalization along with suchlike the Columbus Project. Purpose: This research was conducted to identify the difficulties Korean pharmaceutical companies perceived and to discover the gap in the needs for the government aid the companies have been seeking in the purpose of entering the developed pharmaceutical markets. Method: A survey method was used for this research. Six experts were surveyed and provided comments for the pre-questionnaire. Then, a final questionnaire was developed consisting of 10 items on regulatory-related and another 10 items on non-regulatory-related factors in drug exportation using the Likert scale (1 to 5). The survey sample was 30 Korean companies which have participated in the Columbus Project since 2010. Results: Nineteen (63%) companies responded to the survey. Most companies perceived difficulty (mean = 4.19) over the entire pathway of the regulatory process of global markets. Clinical trials and post-marketing surveillance were remarked as the most difficult barrier to follow the regulatory globalization. Among non-regulatory related factors, marketing, arranging a distribution network, obtaining experts, and projecting a timeline in exportation were brought up as the most difficulty. Conclusion: Especially, cost and language barrier were considered as the main cause producing these difficulties across regulatory and non-regulatory processes and accordingly, securing both long term budget and experts at governmental level was suggested by the domestic pharmaceutical companies.