To ensure a stable supply of drugs under Taiwan's National Health Insurance (NHI) system and to mitigate risks associated with global economic shifts, rising costs of raw materials, and transportation, the National Health Insurance Administration (NHIA) has taken steps to safeguard public health and safety. In alignment with the World Health Organization's call for local manufacturing, the NHIA has amended the National Health Insurance Drug Reimbursement Benefits and Payment Standards (hereinafter referred to as the "Drug Payment Standards") and the National Health Insurance Drug Price Adjustment Guidelines (hereinafter referred to as the "Drug Price Adjustment Guidelines"). The revised provisions were officially announced by the Ministry of Health and Welfare on April 26, 2025.

The NHIA stated that the recent amendments to the Drug Payment Standards and the Drug Price Adjustment Guidelines will benefit public access to medication, support the future development of the pharmaceutical industry, and promote the inclusion of new drugs. Notably, the revisions introduce a parallel review mechanism and a mechanism for proactive drug listing by the insurer. To support domestic pharmaceutical innovation, newly developed drugs that are launched within two years in one of the world's ten most advanced countries, or new chemical entities that have been on the market in those countries for over five years but are manufactured domestically, may be granted favorable pricing similar to that of first-in-Taiwan new drugs.

Secondly, to support the timely market entry of generic drugs and biosimilars, the policy allows the first two domestically manufactured generic drugs or biosimilars that obtain marketing authorization in Taiwan—within five years after the patent expiration of the original brand-name drug—to receive reimbursement at a price equal to that of the original drug.

Third, for generic drugs that meet any one of the following conditions: (1) use of domestically produced active pharmaceutical ingredients (APIs); (2) completion of safety clinical trials either domestically or internationally, with results published in international academic journals and incorporated into the drug's package insert; or (3) being the first to submit a Paragraph IV (P4) patent certification to the competent authority and receive marketing authorization—any of these qualifications will entitle the drug to a 10% price premium under NHI reimbursement adjustments, provided the final price does not exceed that of the original brand-name drug.

Fourth, to ensure a stable supply of pharmaceuticals, if the following three conditions are met simultaneously—(1) the drug is listed as an essential medicine by the competent authority, (2) there is a domestically manufactured item within the same group (for antimicrobial agents, domestic manufacturing is not required), and (3) the number of items in the same group does not exceed three—then the drug price will remain unchanged for the year.

The NHIA emphasizes that the purpose of this amendment is to support both domestic and international pharmaceutical companies in manufacturing locally, and to encourage domestic manufacturers to invest resources or expand production capacity. The goal is to enhance the accessibility of medicines for the public, accelerate the inclusion of new drugs in the National Health Insurance system, ensure a stable and reasonable supply of medications, and safeguard patients' access to necessary treatments.