In China, there are basically four expedited approval pathways – Priority, breakthrough, special, and conditional drug review. A conditional NDA/BLA approval can be achieved for drugs with sufficient clinical efficacy data to predict the clinical value in the treatment of severe life-threatening... Read More
Up until 10 years ago, very few phase 1 studies were done in Asia. With limited drug R&D capabilities, new drugs mostly came from the US and EU. According to a recent report by Novotech, the last ten years have seen a... Read More
In April 2020, China’s NMPA issued GB 9706 for medical electric standards to take effect on May 1, 2023. On March 16, 2023, the NMPA promulgated – A Notice on the Implementation of GB’s 9706.1 – 2020 and supporting standards. This regulation... Read More
While China’s device market is still growing in double digits, several factors have made it harder for foreign companies to succeed there. China wants to make more of its own devices and export them to the rest of the world. The Chinese... Read More
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