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
由于临床试验费用低、病人人数众多及技术人员专业度高等原因，制药公司经常选择在印度进行临床试验。然而自2012年下旬开始，修改后的法规使获得临床试验安全许可的程序变得异常严格。这一变动令印度临床试验数量由2011年的500宗下降为2013年的20宗。法规同时影响了新药品的开发和注册，新药品数量由2008年的260种下降到2013年的不到25种。而国际药品在印度销售的核准程序则由六个月增加至三年以上。 三个新的临床试验委员会相继成立，但2013年9月到12月期间仅有五项药品临床试验被批准。在10月下旬，高级法庭暂停了157项早先已被批准的试验，留待新委员会审批。 许多跨国制药公司已不再选择印度进行临床试验，现在中国是非西方试验地点的首选。美国国家卫生研究院中止了超过35宗正在印度进行的临床试验。印度境内公司也在将试验转移至国外，这使得药品研发成本的上涨幅度最高达到20倍。Priamal、Biocon和Lupin等公司已将试验转移到台湾、德国、美国、加拿大、荷兰和澳大利亚等国家。许多印度临床试验服务公司（CRO）也将试验中心设在马来西亚和泰国等东南亚国家。 2014年2月初，印度卫生及家庭福利部部长承认临床试验法规正在阻碍创新，因此新标准或许将会较为宽松。 Read More
China's medical device market has grown to $13 billion, the second largest in Asia after Japan. The number of foreign medical device manufacturers registering their products in China has grown exponentially. View our webcast to learn about the new regulations in China.... Read More
As China's Food and Drug Administration (CFDA) undergoes reorganization, it is placing more emphasis on post-market compliance for medical devices. This includes changes to processes such as Adverse Events (AE) reporting and the re-registration of medical devices. Both of these processes will... Read More
China’s pharmaceutical market is booming! The market is growing almost 15% annually and is expected to be about $100 billion dollars in 2017. However, drug regulations are complicated in China. In addition, once your drug is approved, what needs to be done... Read More
Certain high-risk Class III medical devices will be subject to clinical trial pre-approval under a new catalogue proposed by China’s Food and Drug Administration (CFDA). The Catalogue of Class III Medical Devices Subject to Clinical Trial Authorization was released on September 30,... Read More
Since India’s Supreme Court transferred the power to regulate clinical trials from the Drugs Controller General of India (DCGI) to the Ministry of Health (MOH) on January 3, 2013, just 12 clinical trials had been approved for the first six months of... Read More
China’s Food and Drug Administration (CFDA) has proposed exempting 25 categories of Class II medical devices from clinical trials. Altogether, there are 142 devices on the draft list, including: Single-use, sterile tissue clamps Blood and infusion warmers Medical gas alarm systems Portable... Read More
In May 2013, India’s Drug Technical Advisory Board (DTAB) recommended requiring the audio or video recording of informed consent in Indian clinical trials. If approved by lawmakers, the new proposal will be inserted into Schedule Y of the Drugs and Cosmetics Rules.... Read More
The pharmaceutical market in Malaysia is worth $3.2 billion, about three times the size of Singapore's market. It is growing rapidly, at a pace of 11 percent per year. As Malaysia's economy booms, spending on healthcare is up. The country's 28.9 million... Read More