This article was originally published on MedTech Intelligence Over the last few years, we have encountered this problem with a number of clients. Once you have received an initial reimbursement price where your sales price in Japan does not yield a profit,... Read More
The Health Sciences Authority (HSA) is moving Singapore medical device submissions to a new e-platform known as the Singapore Health Product Access and Regulatory E-System (SHARE) effective on July 14, 2025. The new system simplifies application procedures and improves user experience throughout... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the entry of 11 new drugs into the National Health Insurance (NHI) reimbursement system effective May 21, 2025. The newly listed drugs include BeiGene’s cancer immunotherapy Tevimbra (tislelizumab), Servier’s Tibsovo (ivosidenib) for... Read More
On June 16, 2025, China’s National Medical Products Administration (NMPA) released a new “Guidance for the Classification of In Vitro Diagnostic (IVD) Reagents Related to Next-Generation Sequencing (NGS),” effective immediately. The document explains classification and regulation rules for NGS-based IVDs and requests manufacturers... Read More
In a major shift from its history of reliance on overseas drug approvals, Hong Kong will start independently reviewing and approving drug products starting from next year. Currently, new drugs can be registered in Hong Kong after being approved by two or... Read More
Japan’s 2025 AI Bill highlights a regulatory change that values innovation rather than restriction, specifically in the pharmaceutical industry. In contrast with the EU’s rule-based system, Japan promotes voluntary compliance and collaboration, with flexible guidelines that speed up drug development. While this... Read More
China is doing exceedingly well in developing new drugs and biotech products. About one-third of global MNC licensing deals are now with Chinese drugs in development. One of the reasons for China’s success is a large pool of science talent and the ability... Read More
On 1 May 2025, Thailand’s Food and Drug Administration (TFDA) launched its new e-Certificate system. Certifications of all health products in Thailand are now online. The system aims to reduce some of the bureaucratic hurdles for manufacturers, importers, and distributors, with quicker,... Read More
In late April, Taiwan’s Ministry of Health and Welfare formally promulgated amendments to Taiwan’s Drug Reimbursement Benefits and Payment Standards of the National Health Insurance and Drug Price Adjustment Guidelines. This is part of the general effort of the National Health Insurance... Read More
On May 16, 2025, the Ministry of Health of Vietnam (MOH) published Circular No. 12/2025/TT-BYT, which substantially changes the drug registration framework in Vietnam. One key change entails the removal of the current fixed listing of over-the-counter (OTC) drugs. Instead, Circular 12 introduces... Read More