Since the introduction of substance patents in Korea, many pharmaceutical companies have made efforts to develop new drugs, and as a result, many new drugs have been launched in Korea. Since then, various researches such as new drugs, biopharmaceuticals, herbal medicines, medical devices, and functional foods have been conducted, making it a global pharmaceutical powerhouse. Therefore, in order to achieve the greater goal of global new drug development, Korea is urgently required a strategy to secure international reliability and minimize time and cost by conducting non-clinical trials that meet global standards.
Accordingly, the quality of domestic non-clinical trials is improving day by day with the introduction of GLP in 1988, mutual certification of OECD in 1996, mutual certification of OECD in 2001, and introduction of compulsory non-clinical GLP in 2003.
However, it is also true that the size and manpower of domestic pharmaceutical companies is relatively small compared to global multinational pharmaceutical companies. To overcome this, all non-clinical experts from domestic pharmaceutical companies must cooperate together to share knowledge and experience.
Related meetings can also achieve this purpose, but there are many difficulties in solving broad and minor problems, and the exchange of information also has limitations. It was judged that through consultations with domestic non-clinical experts, they could explore the direction of each other's development, and the Korean Non-Clinical Society (KSNS) was launched in April 2004 and reached the present.
The Korean pharmaceutical market is small enough to account for only 1% of the world market, and is already saturated with intensifying competition with foreign companies. Therefore, for the survival of domestic companies, the method of creating a global giant drug is considered the most ideal method.
According to USFDA data, new drug development takes an average of 12 years or more if multinational pharmaceutical companies with a lot of experience and rich capital proceed as quickly as possible. If you have no experience and don't have a lot of money, it could take 12 years or more. The reality is that it is very difficult for pharmaceutical companies to successfully complete NDA (new drug license) and generate profits.
In the case of domestic pharmaceutical companies, it is very difficult to conduct successful non-clinical and initial clinical trials because there is little experience in developing a global giant drug as well as having successfully licensed it. Among these, some pharmaceutical companies have experience in licensing and new drug development, so sharing and cooperating with each other even with little experience and knowledge that domestic pharmaceutical companies have will help a lot in new drug development. In addition, the exchange of information with related companies such as CRO, CMO, and consulting will change not only the conditions for new drug development but also the attitude of mind.
The Korean Society of Nonclinical Study
