Tax
1.Amendment to Enforcement Rules of The Taxpayer Rights Protection Act
On 25 May 2026, the Ministry of Finance announced the amendment to the “Enforcement Rules of The Taxpayer Rights Protection Act”. We summarize below:
(1) To stipulate that the competent authority shall complete a public hearing and a tax expenditure evaluation prior to submitting the proposed legislation to the Executive Yuan for review, and the scope of such evaluation items is further clarified. In addition, tax expenditure laws proposed by legislators shall, in principle, also be subject to a tax expenditure evaluation.
(2) To stipulate that taxpayer ombudsmen may be appointed from external experts and scholars.
(3) The amended provisions would take effect on 28 May, 2026.
Reported by: Alex Li / Zoe Chen
Financial
2.Regulations Governing the Preparation of Financial Reports by Financial Holding Companies
On 26 May 2026, the Financial Supervisory Commission (FSC) issued an interpretation regarding Article 20, Subparagraph 26 of the “Regulations Governing the Preparation of Financial Reports by Financial Holding Companies”. We summarize below:
(1) Financial holding companies with insurance subsidiaries may defer the disclosure of group capital adequacy ratio information when filing their annual and semi-annual financial reports during the period from 2026 to 2028; and
(2) Such information may be supplemented and disclosed on the Market Observation Post System within four months after the end of each fiscal year or within three months after the end of each semi-annual period. The financial holding company shall also explain in the notes to its financial reports the legal basis for the deferred disclosure and the expected timeline for the supplemental disclosure.
Reported by: Stacy Lo / Maggie Tsai
SITE/SICE
3.Relaxation of Restrictions on Discretionary Investment Enterprises Engaging in Securities-Related Derivatives Transactions through Over-the-Counter Negotiated Trading Using Discretionary Investment Assets
On 13 May 2026, the FSC announced a ruling relaxing the restrictions applicable to discretionary investment enterprises engaging in securities-related derivative transactions through over-the-counter negotiated trading using discretionary investment assets. Under the ruling, where the client is a professional institutional investor or a high-net-worth institutional investor, the counterparty is exempted from the restriction prohibiting it from being an interested party of the discretionary investment enterprise.
Reported by: Jeffrey Liu/ Eden Hsieh
4.FSC Proposes Easing Reporting Requirements for SITEs and SICs on Non-SIT Fund Products Related Businesses
On 15 May 2026, the FSC announced the draft “New Types of Business for SITE/SICE Under Item 3, Paragraph 3 of Article 3 of the Securities Investment Trust and Consulting Act.” We summarized below:
(1) To remove the requirement that changes to approved matters be reported to the SITCA on a case-by-case basis within ten business days, and instead require that such changes be included in the periodic report submitted to the SITCA by the tenth business day of each month.
(2) To simplify the relevant administrative procedures by replacing the requirement to submit a profile of the entrusted foreign asset management institution with a requirement to submit documentary evidence showing that such institution has obtained the relevant license or qualification in its place of registration.
Reported by: Jeffrey Liu/ Linda Guo
Food and Drug Administration
5.Amendment to Review and Registration Guidelines for Biosimilar Drugs
On 22 May 2026, the Taiwan Food and Drug Administration (TFDA) announced draft amendments to the “Review and Registration Guidelines for Biosimilar Drugs”. These amendments aim to align with the latest international regulatory trends to increase regulatory flexibility, reduce R&D costs and timelines, and accelerate market entry for biosimilars. We summarize below:
(1) Relaxation of Comparative Efficacy Studies Requirements
(a) If evidence from quality comparability studies is sufficient, and physicochemical and functional data are highly predictive of clinical outcomes, the “residual uncertainty” can be minimized, allowing for a reasonable reduction in the scale of non-clinical and clinical trials.
(b) Extending the core concept of “structure determines function” from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q5E guideline, if significant structural and functional comparability with the reference product is proven, a Comparative Efficacy Study (CES) may not be required as evidence of equal efficacy to the reference product.
(c) Developers are advised to consult with regulatory authorities early in the R&D phase to carefully evaluate the purpose and necessity of conducting a CES. Furthermore, an ICH M18 working group was established in 2025 to draft guidelines regarding the considerations for conducting comparative efficacy studies for biosimilar drugs.
(2) Increased Flexibility for New Usage and Dosage
(a) In principle, the usage and dosage of a biosimilar should be identical to its reference product.
(b) If the reference product has obtained a new usage or dosage in the top ten advanced medical countries but has not yet obtained such approval in Taiwan, applicants can submit supporting scientific and clinical data for TFDA to review on a case-by-case basis.
(c) For higher-risk changes in usage and dosage (e.g., increasing the dose or accelerating drug administration), solid clinical trial data is still required for support.
(3) Alternative Sourcing for Reference Products
(a) When access to the reference product or its related data is limited, drugs approved in the US or EU from the same original developer may be accepted as an alternative source for the reference product (R).
(b) Applicants must provide relevant data demonstrating that the active ingredient, dosage form, formulation, strength, dosage, and route of administration of the chosen alternative reference product are identical to the Taiwan-approved reference product.
(c) If an unapproved comparator drug (R’) is used in clinical trials during development, a three-way analytical comparability study (comparing the proposed biosimilar, the Taiwan reference product R, and the comparator drug R’) is required for bridging.
Reported by: Jolene Wang / Crick Liang
| Editors: Mike Lu (Partner) Stacy Lo (Partner) Jeffrey Liu (Partner) Kang-Shen Liu (Partner) David Tsai (Partner) Angela Lin (Partner) Paul Hsu (Partner) Alex Li (Partner) | Counselors: Echo Yeh Sue Su olene Wang (Lexcel Partners IP Firm) |
