Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
Decentralized clinical trials in China are growing due to a variety of reasons. First, China is a large geographic area (the same geographic size as the US) where most advanced medical research is concentrated in its big cities. However, many patients find... Read More
In late October, the Chinese CDE outlined a strong recommendation for the review of clinical trials in China before they occur. In the past, the CDE mentioned the need for clinical trial sponsors to consult with them but recently, this recommendation has... Read More
According to GlobalData, Asia accounted for 50% of the world’s drug clinical trials over the last five years. The reasons for this include a large diverse population, improved healthcare institutions, lower costs, prevalence of certain diseases, etc. The number of clinical trials... Read More
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While RWE is fairly prevalent for US and EU drug companies in their home markets, this has not been the case in Japan. However, according to a recent McKinsey article, this will change in the near future and become a more common... Read More
On July 8, the Indian government issued new legislation to get shareholders’ feedback. This legislation started in 2016 and is trying to replace the Drugs and Cosmetics Rules of 1945. New definitions for investigational new drugs, medical devices, clinical trials, etc. were included. New severe penalties... Read More
The Filipino FDA has proposed a shorter review time for drugs if their clinical studies are completed successfully and approved by the US FDA, PMDA, TGA, EMA, and UK/Canadian FDAs. These approvals would only apply for drugs that can help with health... Read More
On March 21, 2022, China’s Ministry of Science and Technology (MOST) released the draft version of the Implementing Rules for Human Genetic Resources Management to seek public opinion by late April. The release of this document signals the Chinese authorities’ intention to help facilitate clinical... Read More
The China NMPA recently announced that the updated China Good Clinical Practice (GCP) for Medical Devices will come into effect on May 1, 2022. The GCP was promulgated in 2016 in order to ensure the quality of medical device clinical trial management,... Read More