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
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
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
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