On April 1, 2023, new drug prices will take effect in Japan. While price reductions have historically been every two years, recently, new price lists have been announced each year or during so-called “off years”. If the difference between the National Health... Read More
China’s National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security (MHRSS) announced in mid-January the drugs added to the 2022 NRDL. In exchange for drug reimbursement, an average price cut of about 60% was accepted by these... Read More
Since 1999, Japan’s MHLW has had strict restrictions on the disclosure of Japanese drug clinical trial information to non-medical audiences. Information like the name of the investigational drug or the specific clinical trial code was not available. On January 24 this all changed. Now,... Read More
On January 13, various members of the Japanese Health Ministry met and discussed the need to improve orphan drug designation and approval. Increased funding for orphan drug development was debated. Orphan drug designation (ODD) can be achieved in the West with Phase... Read More
About 2 years ago, China implemented its patent linkage system. Geared towards helping foreign companies to bring new drugs to China and helping local Chinese generic companies promote their products, to date, about 30 patent linkage cases have been reviewed by the... Read More
In late 2022, the Korean Pharma Association did an evaluation of over 200 drugs that were approved in Korea between 2011 – 2022. Western countries and Japan have been able to reduce the review times for new drug approvals, but during this... Read More
Contact us today for a free consultation with a China reimbursement consultant to discuss your specific needs. While drug registration in China is easier today, market access is more challenging. Many foreign drug companies have seen their drug prices significantly reduced over... 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