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Growth in the Asian Medical Device Market Read More

Drug Development and Pricing in Korea Read More

亚洲医疗器械市场的增长 Read More

韩国的药品开发及药品定价 Read More

Korea’s Ministry of Health and Welfare (MOHW) is in the process of implementing 19 key deregulation projects. Of these 19, 10 have already been completed and 9 are underway. The measures include regulatory improvements such as improving the evaluation process for new... Read More

韩国卫生和福利部（MOHW）正在实施19个重点项目的放松管制的过程。这19个项目中，10已经完成和9正在进行中。这些措施包括监管的改进，例如改进对新医疗技术的评估过程。 从2014年9月起，制药公司能够在获得韩国食品和药品安全监督部（MFDS）的产品注册批准之前，开始向健康保险审查和评估服务局（HIRA）申请产品的医保报销目录。此前，公司不得不等待MFDS审批通过后，才能申请报销目录。 HIRA还实施了一些改进措施，以更迅速地审核报销目录的申请。 如果一家公司同时进行上述两项申请，它应该能够使该药物产品在韩国市场的上市加快1-2个月。 此外，MOHW正在继续努力改革韩国的药事法。修订草案在2014年3月发布，修改的内容包括了改革专利申请、仿制药替代、第一个仿制药的排他性、药品批发、OTC药的销售、罚款和其他行政措施。预计药事法的最终草案将于2015年3月15日实施，将伴随着详细的配套法规和法律的颁布。 Read More

The developing world is experiencing more Western diseases as they consume more Western products such as fast food, leading to a rise in the cardiology, orthopedics, and cancer rates. This means that the developing world is seeing a growing demand for devices... Read More

South Korea, a country in Northeast Asia with a population of 49 million, has become a global clinical trial hub over the past decade. The Korean government has offered a variety of incentives to support the countrys biotechnology and clinical trial industries.... Read More

There is a wealth of opportunities for healthcare companies looking to expand to the Asian markets. This presentation provides an overview of important business and regulatory issues to consider for medical device companies interested in Asia. To view these presentation slides, please... Read More

在过去的10年里，韩国已经成为跨国临床试验中心。韩国政府向临床试验产业提供了各种激励措施。韩国拥有一个透明的监管体系，更是在亚洲临床试验研究发展最快的的国家之一。许多主要的国际临床研究机构和制药公司都在韩国开展临床试验工作。 Read More