China: Medical Device/In Vitro Diagnostic Clinical Trials Update On July 30, 2014, the China Food and Drug Administration (CFDA) released detailed information on implementing the revised Regulations on the Supervision and Administration of Medical Devices. Order No. 4 covers Administrative Measures for... Read More
Medical devices in India are regulated under the Drugs and Cosmetics Act, which focuses on drugs and not devices. As of now, there are no separate medical device regulations, although a new medical device bill has been pending in India for over... 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
2014年7月30日，国家食品药品监督管理总局（CFDA）颁布了新修订的医疗器械监督管理条例的实施细则。其中包括局令第4号医疗器械注册管理办法和局令第5号诊断试剂注册管理办法。这些实施细则也涵盖了有关临床试验的最新要求，这些新规定将于2014年10月1日起执行。 Read More
This Japan drug regulatory PowerPoint presentation covers many basic issues for international drug companies looking to gain more knowledge about the Japanese drug market. It includes information on registering ethical, biological, orphan, and generic drugs in Japan. The presentation also provides information... Read More
Over the past 10 years, South Korea has become a hub for multinational clinical trials. The Korean government offers a variety of incentives to the clinical trial industry. The country also boasts a well-defined regulatory process and one of the fastest clinical... 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
In the first half of July 2014, Indias Central Drugs Standard Control Organization (CDSCO) released more than 10 notices and orders related to clinical trials. Clinical trial investigators, sponsors, Ethics Committees, and the regulator will be held responsible for ensuring that trials... Read More
2014年7月上半旬，印度中央药品标准控制组织（CDSCO）公布10余项和临床试验相关的管理规定。临床试验的研究者，申请人，伦理委员会和监管机构将负责确保试验设计妥当。临床试验的研究者规定在同一时间内最多同时开展3个临床试验。 CDSCO还讨论了如果试验参与者死亡或受伤，临床试验所应提供参与者的赔偿问题。 Read More
This report on Asian CROs provides a comprehensive list of contract research organizations in Asia. The countries covered include: Japan, Taiwan, Korea, Singapore, Hong Kong, India, China, Malaysia, Philippines, Indonesia, Thailand and Vietnam. Included for each CRO are contact information, description of... Read More