Artificial intelligence is transforming healthcare in Asia: improving the quality of care, facilitating operational efficiency, and increasing patient access. For example, the National University Health System (NUHS) in Singapore uses AI to accurately predict how long patients will stay in the hospital,... Read More
In late November, China’s Joint Drug Procurement Office promulgated the 10th round of Volume Based Procurement (VBP). To be eligible for this bid of 60 drugs, applicants needed to submit their price proposals by mid-December. Of these 60 drugs, there were eight... Read More
Late last year, Vietnam issued a new law updating and augmenting their 2016 Law on Pharmacy. The updated drug law will simplify some drug regulations and begin on July 1, 2025. On the product registration front, if the drug has been approved... Read More
Malaysia’s drug market is growing at about 6% per year, but not easy to succeed in. First of all, registering foreign drugs in Malaysia takes a long time and is fairly demanding on the regulatory front. Second, generally, the existing IP protection... Read More
In late 2024, the FDA of the Philippines outlined a new regulation for all companies importing, exporting, manufacturing, and selling medical products. This new Administrative Order is Order #2024-0015, an update from an older 2020 regulation. The new order covers all types... Read More
In late October, China’s NMPA announced that they had started a new program in 2 locations to simplify the process for the approval of innovative drugs. “Advanced Acceptance Services” will become available for applications qualified for priority review or conditional approval as early as November 1, 2024 – following appropriate pre-application consultations.... Read More
On November 21, Korea introduced the “Immediate Market Entry Medical Technology System,” a ground-breaking policy aimed at accelerating market entry for cutting-edge medical technologies. Before this system was initiated innovative devices could take up to 490 days to be approved. Under this new system, innovative... Read More
Over the last year or so, we have reported on the many ways the Japanese government has tried to reduce Japan’s drug loss. So many drugs are approved in the West but not yet available in Japan. Such measures have included a... Read More
On November 14, China’s NMPA announced the document titled “Interim Provisions on the Administration of the Designation of Domestic Responsible Persons by Overseas Drug Marketing Authorization Holders.” These provisions outline the requirements for domestic responsible persons. Imported pharmaceuticals’ quality and safety are... Read More
In the past, medical device reimbursement in Japan has been a function of – 1. Functional Categories, 2. Foreign Reference Pricing (FRP) and 3. Cost accounting. While functional category and cost accounting are still very important for reimbursement, foreign reference pricing has... Read More