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
On December 12, 2022, the Ministry of Food and Drug Safety (MFDS) announced that they will resume KGMP on-site audits starting on January 1, 2023, for all Class 2, 3, and 4 devices for registration approvals in Korea. Over the COVID period,... 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
Japan has been very apprehensive about the so-called “drug loss” for its citizens. Many new foreign biotech companies seem to be declining Japan’s entrance due to limited reimbursement pricing mechanisms for expensive new products, especially for drugs for children, rare, and intractable... Read More