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
新加坡卫生科学局（HSA）计划对药品注册的监管进行转移，从目前的在药品法和毒药法令的监管控制下，转移到保健品法案下进行管理。HSA认为，这将有助于使目前新加坡的药品注册监管更新，更透明和简化。 根据所提议的改变，药物将被称为“治疗产品”，定义为“一种保健产品，其预期用途是以治疗、预防、缓解或诊断为目的。”这一类别包括化学药和生物制品。 在这一监管举措的变更下，HSA将在保健品法案下实施四套附属法例。这项立法将涵盖药品生产、注册、临床试验、供应、进口、广告、不良事件报告和执法措施。一些规定将在此过程中被更新。HSA已经宣布，它将计划在2015年的第三季度实施这些新法规，。 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
Singapore’s Health Sciences Authority (HSA) is planning to transfer regulatory control of drug products, currently regulated under the Medicines Act and the Poisons Act, to the Health Products Act. The HSA believes that this will help update, clarify and streamline Singapore’s existing... Read More
The key stakeholders who are involved in drug approvals in China are: Drug manufacturers Distributors Central government: various agencies Provincial government: various agencies Hospitals: various classes and levels KOLs and physicians For more information about the regulatory framework in China, please see Pharmaceutical and... Read More
The China Food and Drug Administration (CFDA) has been working on a revision to the countrys Drug Administration Law. A draft version could be submitted to Chinas State Council by the end of 2014. Read More
Joko Widodo was inaugurated as the new President of Indonesia on October 20, 2014. One of the tough challenges Widodo’s administration will face is reforming the healthcare system. Indonesia has a complicated, decentralized healthcare system that spreads responsibility from the national level... Read More
For more information about the regulatory system in Hong Kong, please see Hong Kong Medical Device Regulations. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge Medical... Read More
The Thai Food and Drug Administration (FDA) recently announced an electronic common technical document (eCTD) pilot program for drug application dossiers. The pilot program will start in October 2014. After feedback from the pilot, the Thai FDAs electronic submission system will be... 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