Rare disease care across Asia is advancing on two fronts: faster regulatory pathways for orphan drugs, and slow-building efforts to fund and diagnose the roughly 258 million people in Asia living with rare conditions. China’s revised Drug Administration Law implementing rules, effective... Read More
Taiwan’s Food and Drug Administration has advanced two notable regulatory updates this month. Registrants filing low-risk Class I devices may now use the agency’s Medical Device Premarket E-submission System, which eliminates the need for hard-copy documentation. In addition, the TFDA issued new... Read More
A new trade agreement between the United States and Taiwan includes measures to expedite the regulatory review of innovative pharmaceuticals and medical devices manufactured in the US. Under the agreement, approval from the US Food and Drug Administration may be used as... Read More
Japan’s Cabinet Office has recently approved a 330 billion JPY (2.1 billion USD) support package to encourage drug discovery and strengthen the country’s biopharma sector. Key allocations include nearly 50 billion JPY (323 million USD) for bioclusters and biotech infrastructure, 20 billion... Read More
The Taiwan Food and Drug Administration (TFDA) has recently promulgated updated technical guidance on artificial intelligence-based medical devices, which came into effect on August 14, 2025. The new guidelines will replace the 2023 edition and incorporate additional clarification and detailed requirements for... Read More
On July 31, 2025, Taiwan’s Ministry of Health announced a phased plan to digitize drug package inserts, moving everything to a digital and paperless format. By December 31, 2025, all prescription and non-prescription drug inserts must be structured electronically and uploaded to... Read More
Over the past few years, Taiwan has enacted several significant reforms that have reshaped the regulatory framework for medical devices. These changes encompass a diverse range of topics, from regenerative medicine and digital health to product registration and classification, as well as... 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
Taiwan’s National Health Insurance Administration (NHIA), a division of the Taiwanese MHLW, has announced a new program to fund new cancer drugs. The goal is to expedite the incorporation of new cancer drugs into the national healthcare scheme. The program is called... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More