한국의 신약 허가기간에 대한 조사 연구(2011~2017년)

Study on New Drug Application Timeline in Korea between 2011 and 2017

In many countries, there is a growing interest in the new drug approval timeline as well as drug lag for new drug approval. We examine the actual timeline required for the approval and NDA (New Drug Application) review timeline, analyzed the relevant influencing factors in Korea, also compared drug lag with that in the US and Europe. This study was conducted on approved new drugs in Korea from 2011 to 2017 by KRPIA (Korea Research-based Pharmaceutical Industry Association) members. The data set included drug name, active ingredients, company name, orphan drug status, therapeutic class, application date, approval date etc. NDA review period represented the difference between the date of submission and the date of approval by the MFDS (Ministry of Food and Drug Safety). Relative submission gap was measured by the difference between the earliest submission date in FDA (Food and Drug Administration) or EMA (European Medicines Agency) and submission date in MFDS, and approval gap was calculated from the earliest approval date in FDA or EMA to approval date in MFDS. Regression analyze was used to identify the factors associated with NDA timeline. In total 115 approved new drugs in Korea, the average NDA timeline was 299.7days (median=293 days), and delayed by 15.3days (p=0.0250) on average over time. The study contained 73 chemicals (63.5%) and 42 biologicals (36.5%). In the case of orphan drugs, the NDA timeline was 187.1days faster than general new drugs on average (p<0.0001). There was a difference by TA (Therapeutic Anatomy), but it wasn’t statistically significant.