Starting on March 1st, 2023, China’s Provisions on the Supervision and Administration of Drug Market Authorization Holder Implementation of the Main Responsibilities of Drug Quality Safety, was implemented. The goal of these provisions is to require drug market authorization holders (MAHs) to... 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
In March 2021, the NMPA promulgated a regulatory notice on device master files. On January 18, 2023, they issued another notice titled – Further Clarity on the Registration and Use of Medical Device Master Files. Device Master Files are used to protect... Read More
For medical device registration in China, after a dossier is reviewed by the CMDE, additional information is almost always requested during the supplemental submission phase. Requested information can include things like additional supporting documents, more technical information, corrections of translations, etc. In January 2020,... 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
While still behind the US and EU CDx markets to date, over the next 5 years, more and more CDx’s will be registered and used for precision medicine in Asia. Drug companies doing clinical trials and launching new drugs in Asia will... Read More
Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs. While the China device market is huge and growing very quickly, once your device is approved there, market access can be very challenging. The... 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