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
In January, Singapore’s MOH updated GN-26 and GN-27 SAR for non-registered medical devices. Doctors, medical institutions, and labs can now more easily import non-registered Class D devices that are new or have new indications, or are new implants. Certain categories of non-registered... 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
Like most countries, downward drug pricing is the rule of thumb. If there is a discrepancy in Japan between NHI prices and market prices, normally a revision is done. While historically, Japan only adjusted drug prices every 2 years, recently that has... 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
The Medical Technology Association of India (MTaI) has recently requested the Indian government to enact reforms in the Union Budget of 2023. These reforms coincide to the Modi government’s desire to improve healthcare in India. One of their suggestions is to lower... Read More
In early January, the Vietnamese government extended the validity of certain drug licenses. First, drugs and drug substances with market authorizations that expire this calendar year will be automatically extended until December 31, 2024. Second, drugs and drug substances with market authorizations... Read More
Starting January 1, 2023, the Indian government requires all Active Pharmaceutical Ingredients (APIs) manufactured in India to have QR codes. The reason for this government initiative is to help guarantee the quality and safety of APIs. Historically, about 20% of APIs made... 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
The recording of the webcast can be accessed here. Read More