China’s Center for Drug Evaluation (CDE) issued new guidelines in late July supporting the use of DCT via telemedicine to allow clinical trials to be done remotely. The DCT guidelines may be implemented as long as investigators and sponsors agree and the... Read More
On July 24, China’s NMPA issued a new list of medical devices not subject to clinical evaluation. This announcement is effective now. Now, device companies want to review the Clinical Evaluation Exempt Catalogue before checking the Clinical Trial Exempt Catalogue. For product... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) has announced that all RWE can be used as clinical data to expedite the registration of medical devices that utilize digital technology like AI, Big Data, and some software applications. The MFDS also said... Read More
Before 2013, there were hundreds of clinical trials done in India that resulted in faulty data, lawsuits, and significant problems. From 2013 to 2019, the number of clinical trials in India dropped significantly. However, in 2019, India implemented New Drug and Clinical... Read More
Dealing in the Chinese drug data market has never been easy. Western drug companies that are now doing multi-regional clinical studies that include China, and Western drug companies licensing drugs from Chinese originators, oftentimes need China data to be successful with drug... Read More
Normally, drug approval in Japan is based on clinical trials done under Japanese GCP requirements. On the other hand, clinical research not initially used for drug registration is called Specified Clinical Research (SCR). SCR is regulated by the Japanese Clinical Research law.... Read More
Up until recently in Japan, most drug applications, informed consent forms, and other drug documents needed to be in hard copy with original personal stamps or signatures. On March 30, Japan’s Ministry of Health, Labor, and Welfare (MHLW) authorized the use of... Read More
Up until 10 years ago, very few phase 1 studies were done in Asia. With limited drug R&D capabilities, new drugs mostly came from the US and EU. According to a recent report by Novotech, the last ten years have seen a... Read More
Since 1999, Japan’s MHLW has had strict restrictions on the disclosure of Japanese drug clinical trial information to non-medical audiences. Information like the name of the investigational drug or the specific clinical trial code was not available. On January 24 this all changed. Now,... Read More
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