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
Finding the right Chinese medical executives can be a challenging proposition. Certain positions, like regulatory executives, general managers, and excellent business development executives are currently in short supply. Over the last five years, the salaries of Chinese medical executives have also skyrocketed.... Read More
2014年七月中旬，印度国家药品定价局（NPPA）公布了对50种糖尿病和心血管治疗药物的价格控制。这一轮价格上限控制的药物包括肝素和阿托伐他汀。在过去18个月里，有300多种药物大幅度降价。目前近40％的印度药品设有价格上限。 Read More
In mid-July 2014, Indias National Pharmaceutical Pricing Authority (NPPA) announced price controls for 50 diabetic and cardiac medicines. Drugs included in this round of price caps include heparin and atorvastatin. This move comes on the heels of substantial price reductions to more... 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
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
在日本，孤儿药的认定需要通过日本健康，劳动和福利部（MHLW）部。大量的医疗需求要求开发医疗产品，特别是没有可用的替代疗法的疾患。孤儿药的定义是指对于病患数低于50,000安全和有效的药物。然而，孤儿药的指定并不意味着它会自动给予药物的销售许可。 Read More
In Japan, pharmaceutical products can be given orphan drug designation by the Ministry of Health, Labor and Welfare (MHLW). A high medical need must exist for the product, and there must be no available alternative treatment. The drug must also be safe... 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
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