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医学专家估计，大约有1000万中国患者有某种类型的罕见疾病。然而在中国对研发治疗罕见疾病的药物尚未进行立法。然而，自2009年起，某些治疗罕见疾病的药物被纳入快速审批流程。药品法中有对于研发治疗罕见疾病药物获得减低临床试验的要求的规定。 Read More

2013年尽管全球私人基金对医疗行业的投资下降了一半以上，但对亚洲的投资在持续增长。2011年和2013年间，亚太地区的医疗保健的投资量同比增长了130 ％，其中在印度和中国的投资最多。 Read More

The Indian government has allowed pharmaceutical companies to raise the maximum retail prices (MRPs) for drugs. Pursuant to the Drug Price Control Order (DPCO) 2013, essential medicine prices are capped at the average increase of all drugs in a certain segment that... Read More

印度政府已经同意制药公司提出的药品最高零售价（MRPs）的请求。根据2013年印度政府药品价格管制令（DPCO），基本药物的价格涨价上限为所有药物平均增幅的1％。由于实施2013年的 药品价格管制令，基本药物的价格已经下降了40％。然而，2013年印度政府允许药物批发价格涨价6.32％。目前印度的基本药物目录包括348种原料药（650配方）。 Read More

Malaysia's pharmaceutical market is valued at over $3 billion and has a double-digit annual growth rate. Thanks to an increasingly affluent and expanding middle class, an aging population, urbanization and higher quality healthcare and medicines, Malaysians spent about $400 per person on... Read More

The pharmaceutical market in Thailand had a 2013 value of more than $4.5 billion, almost the same size as the Taiwan market. Already the second largest in Southeast Asia (behind Indonesia). the Thai drug market is projected to double by 2020. Read More

In order to reduce the risk of future patent litigations, the Indian Patent Office (IPO) announced draft guidelines for drug patents on March 7, 2014. A two week period was given for public comment. This draft guideline revision comes in the wake... Read More

为了减少今后专利诉讼风险，印度专利局（IPO）于2014年3月7日公布了新药专利申请指导原则草案。并给出两星期时间，公开征求公众意见。该指导原则草案的修订， 源于印度政府拒绝诺华（Novartis）格列卫（Glivec）7年专利申请的诉讼案。 新的药品专利指导原则草案明确指出“增强治疗效果”是决定是否授予改进药物新专利的唯一标准。“增强治疗效果”替代了以前“增强效果”的提法。这种措辞的变化源于法院对诺华（Novartis）案的裁决。 虽然指导原则草案并非法律，但指导原则草案是专利申请的规范。专利法的相关规定（专利法第3（d）条）并不与新发布的药品专利指导原则草案冲突。而且，最高法院认定新草案中“增强治疗效果”的提法可以在实践中加强监管的力度和水平。 这意味着，在印度得到创新药物产品的专利将会变得越来越困难。药品专利指导原则草案如果得到通过，也将加强印度对药医产品专利申请的程序规范性和管理部门行政执法的一致性。 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

Drug companies have often conducted clinical trials in India because of the country’s low costs, patient availability and technically proficient personnel. But in late 2012, amended regulations made securing permission for a clinical trial a much more rigorous process. This has lowered... Read More