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
Driven by the urgent need to speedily combat the COVID-19 epidemic, Japan plans to ease its famously stringent requirements on clinical trials of vaccines and other essential drugs, laying the groundwork for rapid approval when emergency need is deemed to be overwhelming.... Read More
Moving with increasing urgency to encourage the development of drugs to treat rare diseases, Chinese regulators are planning for the first time to authorize real-world studies of orphan drugs. Technical guidelines released in October by the National Medical Products Administration’s Center for... Read More
Spurred by the harmonization of safety requirements on drug development by regulators in the United States and Europe, Japan’s drug regulators are tightening requirements on the development of new pharmaceuticals. By next year, for example, all products used in clinical trials must... Read More
A working group established in April by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is tackling the knotty issues of how best to employ real-world data (RWD) in formulating regulations of orphan drugs and other novel treatments under development for patient populations... Read More