Archives

Read More

In mid-April, China set forth the bidding results of the 8th national VBP. This program reduced prices by about 50% and affected about 40 drugs. The winning bidders were almost exclusively Chinese drug companies, with only a few foreign companies winning. According... 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

Many global health authorities have already adopted eCTD drug submissions. Singapore too plans to implement this system in the fourth quarter of 2024. To ease the use of eCTD in Singapore, the HSA will broadcast an eCTD regulatory guidance over the next... 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

Currently, while digital health is very prevalent in the West, it is still at an infant stage in Japan. However, this is changing now. In 2020, a startup in Japan called Cure Up received regulatory approval for its nicotine addiction treatment. Also,... Read More

So many Western drug companies source drug products, drug substances, excipients, and drug packaging from China. Many have speculated given the tensions between the world’s two major superpowers – the US and China – this may be a dangerous situation. The COVID... Read More

In China, there are basically four expedited approval pathways – Priority, breakthrough, special, and conditional drug review. A conditional NDA/BLA approval can be achieved for drugs with sufficient clinical efficacy data to predict the clinical value in the treatment of severe life-threatening... 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