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
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
At a March 13 PMDA meeting, the priority review time for SaMD products was set at 6 months. SaMD products with strong effectiveness will enjoy SaMD priority review if the SaMD product is submitted first in Japan or simultaneously with other global... 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
Replacing decree #98 with decree #07 will implement new device regulations in Vietnam. To help alleviate price fluctuations of devices in Vietnam, Vietnam initiated a policy that device traders or manufacturers need to list device prices on the Vietnam medical device portal... 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
While telemedicine is now common in the West, it is also now growing in Asia. Some Asian countries recently outlined new telemedicine regulations. For example, Taiwan’s MOH recently announced draft amendments to their initial telemedicine regulation of 2018. Originally, telemedicine was to... Read More
Recently, the President of Indonesia announced presidential regulation #6 requiring all drugs, biologics, and medical devices to meet Halal law. This law came into effect in mid-January. Medical products that do not have non-Halal components/materials and are made via a Halal manufacturing... Read More