A reform of the NHI drug pricing policy has been discussed for years. Stakeholders have urged the government to strengthen the drug supply chain. The Ministry of Health and Welfare (MOHW) issued an advance notice last year regarding the revision of related regulations. The final version was announced on April 26, and the new regulations will take effect next year. Local pharmaceutical industry has welcomed the revision, believing it will enhance the resilience of Taiwan's drug supply.
The MOHW issued an advance notice last November regarding proposed revisions to the “NHI Drug Reimbursement Items and Payment Standards” and the “NHI Drug Price Adjustment Operational Guidelines,” with a view to ensuring reasonable drug prices and supporting Taiwan-made new drugs. The new regulations, which offer favorable pricing for generics and biosimilars manufactured in Taiwan, will take effect on January 1, 2026.
The new regulations encourage pharmaceutical companies to manufacture new drugs in Taiwan. New drugs that have been launched internationally within the past two years, or those that have been on the market in one of the top ten advanced countries for at least five years but are considered new chemical entities in Taiwan, will be eligible for the same favorable pricing as first-launch new drugs in Taiwan. For original drugs whose patents have expired within the past five years, the first two domestically manufactured generics or biosimilars approved in Taiwan may be granted a price up to that of the original drug.
Ms. Chen Yi-Feng, President of the TGPA, noted that under the new regulations, generics with the same active ingredients, dosage form, and strength as the original drugs can be manufactured five years after patent expiration—a significant reduction from the previous 15 years. This change is expected to greatly improve drug accessibility.
Domestically manufactured drugs may be eligible for favorable pricing, including those that meet any of the following criteria: (1) use domestically manufactured active pharmaceutical ingredients (APIs); (2) have safety test results published in international journals and listed in the package insert; or (3) are the first approved generic with a Paragraph IV (P4) declaration—that is, a statement claiming that the relevant patent should be revoked or that the generic drug does not infringe the patent. Drugs meeting any of these three criteria will receive a 10% price mark-up, provided that the price does not exceed that of the original drug.
For essential drugs designated by the competent authority, if there are fewer than three products in a drug group—including at least one domestically manufactured product—they will be exempt from drug price adjustments for that year to help ensure supply stability. The authority will also accelerate the inclusion of new drugs in the NHI Benefit Scheme, promote the parallel review mechanism, and ease regulations on written application submissions.
The TPMA, CPMDA, and TPGA issued a joint statement expressing appreciation for the government's reform of the drug price policy, which supports local drug manufacturing and strengthens the resilience of the drug supply.
【2025-04-29 / China Times】
