Analysis of drug approval status and drug lags in South Korea and Vietnam : application of statin drugs

다국어 초록 (Multilingual Abstract)

As the Vietnamese population’s average life expectancy is becoming higher so that the population is being exposed to more chronic diseases, uses and prescriptions in statin drugs are also increasing. Considering the exponential growth in Vietnam’s both economy and its pharmaceutical market, analysis in statin drug approval status and drug lags of Vietnam would be crucial for establishment of an ideal export strategy of South Korean statin drugs. Comparison studies on pharmaceutical regulatory systems and drug lags are prevalently established; however, approval status of specific drugs and features in drug approval have not been systematically investigated. In this study, a thorough analysis in Korean and Vietnamese statin drug approval status was fully investigated by using database from Ministry of Food and Drug Safety (MFDS) and the Drug Administration of Vietnam (DAV).
Approved statins that were examined in the study were atorvastatin, rosuvastatin, simvastatin, pravastatin, lovastatin, and fluvastatin from 1990 to 2020. Various categories in approval status were analyzed, which included the number of approved statins, most approved statins, annual statin approval status, and others.
After approval dates were analyzed, a drug lag analysis among statins was conducted. Types of drug lag analysis included global approval lag, drug lag between Korea and Vietnam, and drug lags of first approved brand name statins in each country. For purpose of this study, only relative drug lag was calculated, by assessing the date difference between the first global approval date and the first approval date of Korea or Vietnam.
The number of statin drug approvals was 1.9 times bigger in Korea than Vietnam. In Korea, rosuvastatin (740, 48.7%) occupied the highest proportion whereas in Vietnam, atorvastatin (361, 44.3%) showed the highest proportion. Data indicated that Vietnam has a higher average value of annual approval rate. However, graphs depict that statin approval in Korea are continuously increasing while approval rate stays in range of 55 – 111. Global approval lag for statins was 17.3 months in Korea and 194.8 months in Vietnam. Not only in average value, but also drug approval lag in all statins was found longer in Vietnam than Korea. Data showed Vietnam first approved alternative statins in pravastatin, lovastatin, and fluvastatin, rather than first globally approved statins.

국문 초록 (Abstract)

베트남의 평균 수명이 증가함에 따라 베트남 인구는 만성 질환에 위험에 노출되며 스타틴 약물의 사용 및 처방 또한 급증하는 추세이다. 베트남의 경제적 성장과 제약 시장의 기하급수적인 발전 속도를 고려 하였을 때, 국내 스타틴 의약품의 이상적인 수출 전략을 수립하는 것은 국내 제약산업의 성장에 큰 도움이 될것이다. 국내 스타틴 의약품 수출 가능성을 위하여, 베트남과 국내 스타틴 의약품 허가 현황 및 drug lag에 대한 분석을 하였다. 본 연구에서는 두 국가의 규제기관인 한국 식품의약품안전처 (MFDS)와 베트남 Drug Administration of Vietnam (DAV)의 데이터베이스가 참고되었다. 연구에서 조사된 스타틴은 아토르바스타틴, 로수바스타틴, 심바스타틴, 프라바스타틴, 로바스타틴, 플루바스타틴 총 6개의 스타틴이다. 허가 현황과 관련된 분석 방법은 승인된 스타틴의 총 개수, 가장 많이 승인된 스타틴, 연간 스타틴 허가율 등이 있었다. 스타틴 drug lag에 대한 분석 방법은 상대적 durg lag 분석을 기반으로 하였으며, 분석 항목은 global approval lag, 한국과 베트남 사이 drug lag, 그리고 최초 승인 스타틴의 허가 상태가 있었다. 연구 결과에 따르면, 1990년부터 2020년까지 총 허가된 스타틴은 한국이 베트남에 비해 약 1.9배의 양을 차지하였다. 국내에서는 로수바스타틴 (740, 48.7%)이 가장 많이 허가되었고 베트남에서는 아토르바스타틴 (361, 44.3%)의 허가가 가장 잦았다. 총 6개의 스타틴에 대해서 모두 베트남의 drug lag가 국내 drug lag에 비해 더 높다는 결과가 있었으며, global approval lag의 평균값은 국내에서는 17.3개월, 베트남에서는 194.8개월로 분석되었다.

목차 (Table of Contents)

• 1. INTRODUCTION 1
• 2. LITERATURE REVIEW 15
• 2.1 Cardiovascular Disease Risk Factor Patterns and Their Implications for Intervention Strategies in Vietnam 15
• 2.2 Comparison of drug lag between Korea and Japan using public data of regulatory authority 16
• 2.3 Drug Lag and Key Regulatory Barriers in the Emerging Markets 17
• 2.4 Drug Lag for Inflammatory Bowel Disease Treatments in the East and West 19
• 3. METHODS 22
• 3.1 Data Source 22
• 3.2 Selection of Drugs 25
• 3.3 Drug Approval Status Analysis 26
• 3.4 Drug Lag Analysis 28
• 4. RESULTS 32
• 4.1 Overview of Statin Drug Approval Statuses in Korea and Vietnam 32
• 4.1.1 Status of approved statins 32
• 4.1.2 Analysis in key statins of Korea 41
• 4.1.3 Analysis in key statins of Vietnam 45
• 4.2 Drug Lag of statin drugs 47
• 4.2.1 Global Drug Approval Lag 47
• 4.2.2 Drug Lag between Korea and Vietnam 40
• 4.2.3 Drug Lag by Brand Name Products 42
• 5. DISCUSSION 47
• 6. CONCLUSION 54
• 7. REFERENCES 56