China is the 3rd largest pharmaceutical market globally. The market continues to grow fast, but it is still a self-pay market. Generics dominate the market by volume with lower price, and the market share of value keeps growing. There is often one... 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
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
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
For Class B, C, and D medical devices (see Classification of General Medical Devices in Singapore), there are two submission routes in Singapore: the abridged submission route and the full evaluation route. The abridged submission route is only for medical devices that... Read More
For more information about Singapore’s regulatory framework, please see Singapore 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 (www.pacificbridgemedical.com) and, if possible, a link... Read More
There are many new changes in the Japanese medical device regulations. 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