Please contact us to learn about how we can help you register your CDx product in China. Using Western CDx products, drug companies and their specific drug products can more easily target the right patients with specific diseases. Unfortunately, CDx registration in... Read More
Contact us to learn how we can help you with DMF registration in China. API, excipient, and drug packaging manufacturers that want to protect their intellectual property and manufacturing processes will want to do a China DMF. Manufacturers with EU CEP, US... Read More
More and more drugs are purchased by Volume Based Procurement in China today. In exchange for large volume sales, prices have dropped for many drugs by 50-90%. Sometimes, the winners of these procurements sell drugs with patent infringement. To avoid this issue,... Read More
Getting drug and patient data transferred from China to the West is not an easy process. Data transfer requires approval from China’s Ministry of Science and Technology (MOST). Drug companies need pre-approval or record filing with the Human Genetic Resources (HGR) Administration... Read More
Late last year, China’s NMPA outlined the need for some Class 2 products to get UDIs. The third group of products that need UDIs is over 140 products including devices like vascular suture devices, peritoneal dialysis equipment, ophthalmic instruments, blood cell analysis... Read More
At the end of 2022, the Chinese government lowered import tariffs for several types of products including medical devices. This tariff reduction took place on January 1, 2023. Tariffs were reduced for about 14 different types of medical devices. Starting on July... Read More
Recently, China has shifted towards electronic submissions in an effort to expedite the review and approval process for drugs. At the end of November 2022, the China NMPA announced that starting January 1, 2023, all drug registration applications as well as supplementary information need... Read More
Conditional drug approval in China can be granted if the drug meets certain criteria – 1. it helps patients more than approved therapies, 2. has the same efficacy as existing drugs but has fewer side effects, 3. can help with a public... 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
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