# Authority Map of Regenerative Medicine in Taiwan > Regenerative medicine in Taiwan splits into two paths, products and techniques, but the central competent authority under both the Regenerative Medicine Act and the Regenerative Medicine Products Act is the Ministry of Health and Welfare. Neither TFDA nor the Department of Medical Affairs is a statutory competent authority, and the CDE, which reviews cases every day, is not named anywhere in the fifty-eight articles of the two laws. This piece works through the statutes and the delegation notices to trace where each of the three agencies' powers come from, how asymmetric those powers are, and the one cell on the technique side where I have not yet found the delegation notice. - Author: Paul Kuo（郭曜郎） - Date: 2026-07-15 - Pillar: Reflections & Memory - Tags: Regenerative Medicine, Regenerative Medicine Act, Regenerative Medicine Products Act, Administrative Delegation, Center for Drug Evaluation, Pharmaceutical Regulation, Administrative Procedure Act - Canonical: https://paulkuo.tw/en/articles/taiwan-regenerative-medicine-authority-map/ - Language: English - Translation: AI-translated from the zh-Hant (Traditional Chinese) original - Original (zh-Hant): https://paulkuo.tw/articles/taiwan-regenerative-medicine-authority-map.md - Site index for LLMs: https://paulkuo.tw/llms.txt --- > **TL;DR** Regenerative medicine in Taiwan splits into two paths, "regenerative medicine techniques" and "regenerative medicine products," and the central competent authority under both laws is the Ministry of Health and Welfare. TFDA and the Department of Medical Affairs are merely internal divisions of labor within the ministry and are not themselves the competent authorities under the law. The CDE, which reviews cases every day, is not in either law; its powers come from the ministry's delegation under Article 16 of the Administrative Procedure Act. So handling a single regenerative medicine matter means dealing with several agencies at once, not asking one office and being done. This map puts the source and relationships of these authorities in one place so you can judge which kind of question goes to whom.
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To work out exactly who a regenerative medicine document should go to and which unit to ask, I read through the Regenerative Medicine Act and the Regenerative Medicine Products Act, and drew an authority map. Drawing the diagram with AI is not hard: regenerative medicine techniques follow the Regenerative Medicine Act, regenerative medicine products follow the Regenerative Medicine Products Act, and each has an article number you can point to. The third box is the CDE, whose legal basis is not in either of these two laws. The authorizing provisions of the two laws do not directly say "Center for Drug Evaluation (CDE)"; they say "the central competent authority may entrust its subordinate agencies, or delegate to other agencies (institutions), juridical persons, or bodies, to handle" the matter. In other words, the law authorizes only that a certain class of unit may be delegated to. Who is actually delegated to has to be found by going back to the delegation framework of the Administrative Procedure Act and the delegation notices issued by the Ministry of Health and Welfare. That brings up the question this piece answers: **what role does the CDE, which reviews cases every day, actually play, and what is its legal basis?** --- ![Authority map of regenerative medicine in Taiwan. At the top is the Ministry of Health and Welfare (MOHW), marked as the sole central competent authority under both laws (§2). Below it sit two parallel blocks. On the left is TFDA, the Food and Drug Administration, the product channel and a subordinate agency, with the legal basis being the Regenerative Medicine Products Act as a special law to the Pharmaceutical Affairs Act (§1, §3 II), and its business being registration, conditional approval, GMP, and import. On the right is the Department of Medical Affairs, the technique channel and an internal division, with the legal basis being the Regenerative Medicine Act: no non-medical institution may perform regenerative medicine (§11), techniques require approval plus registration (§12 I), and the human trial principle (§7, §8). In the middle is the Regenerative Medicine Review Committee, established under §5 of the Regenerative Medicine Act, with nine categories of authority (§5 II), its case-by-case review authority being the granting of conditional approvals for products, meeting as a standing committee twice a year (subordinate rule §5); the committee points to TFDA with a solid arrow marked "review §6 II," and to the Department of Medical Affairs with a dotted line marked "consultation." At the bottom is the CDE, the Center for Drug Evaluation, a nonprofit foundation, unnamed in either law, delegated by MOHW under §16 of the Administrative Procedure Act; on the product side it is delegated by TFDA (effective April 30, 2018, currently in force), pointing to TFDA with a green dotted arrow marked "current delegation"; on the technique side the old delegation was under the Special Management Regulations, with its status under the new law still to be confirmed, pointing to the Department of Medical Affairs with an orange dotted arrow marked "to be confirmed." Also noted on the map: it does not decide approvals or rejections because of the scope of its delegation, not because of its status as a foundation (§2 III).](/images/articles/taiwan-regenerative-medicine-authority-map.png) Here is the finished product. The six sections below are the source of each cell on this map. The cell on the technique side is marked "to be confirmed"; the reason is in the last section. ## Who is the competent authority under the law? Under both laws, the answer is the Ministry of Health and Welfare **Many people assume that because TFDA handles products and the Department of Medical Affairs handles techniques, they are the competent authorities. That is not actually what the law says.** That assumption is right in function but wrong in law. Article 2 of the Regenerative Medicine Act and Article 2 of the Regenerative Medicine Products Act each say the same sentence: the competent authority referred to in this Act (this Act) is, at the central level, the Ministry of Health and Welfare. In other words, the statutory competent authority under both laws is the same one. TFDA is a subordinate agency of the Ministry of Health and Welfare, and the Department of Medical Affairs is a department within the ministry; neither is the "central competent authority" under the law. When you place them side by side on the map as two equal blocks, what you are drawing is a division of labor, not statutory authority. The legal basis for that division of labor is clear. The latter part of Article 1 of the Regenerative Medicine Products Act says, "matters not provided for in this Act shall be governed by the Pharmaceutical Affairs Act and other relevant laws," and Article 3, Paragraph 2 is even more direct: a regenerative medicine product "is a drug as defined in Article 6 of the Pharmaceutical Affairs Act." One sentence pins regenerative medicine products into the Pharmaceutical Affairs Act framework, so they naturally fall to TFDA. The Regenerative Medicine Act, on the other hand, is the medical side; Article 11 provides that no non-medical institution may perform regenerative medicine. ## What power does the Regenerative Medicine Review Committee have? It is established in the technique law, yet it reviews products **The most unusual thing about the Regenerative Medicine Review Committee is that it is established under the Regenerative Medicine Act, yet it reviews the conditional approvals under the Regenerative Medicine Products Act.** In other words, it stands where the two laws meet; it does not belong exclusively to the "technique" line. The intuitive way to draw it is to place it on the Department of Medical Affairs line and label it "committee approval," and both of those are wrong. Breaking down the nine categories of authority below shows where the error lies. Under Article 5 of the Regenerative Medicine Act, the committee is formed by the central competent authority. The article says only that it "shall have a number of members" (the figure of thirteen to nineteen comes from Article 3 of the subordinate Organization and Operation Rules of the Regenerative Medicine Review Committee, not from the parent act). Its authority is listed in nine categories in Paragraph 2, seven of which are purely advisory: developing innovation and promoting policy, promoting correct knowledge and ideas, improving patient safety and medical quality, cultivating talent, managing regenerative products and regenerative techniques, assessing implementation results, and other related matters. Only two carry the word "review." The fifth is "consultation and review on research, development, incentives, and subsidies"; the seventh is **the review of conditional approvals for regenerative products**. The difference is that the fifth deals with subsidies and incentives, while the seventh deals with whether a product can obtain a conditional approval. The one that actually stands in an applicant's way is the seventh. And the seventh is on the product side. Article 6, Paragraph 2 of the Regenerative Medicine Products Act writes the same thing from the other end: before the central competent authority grants a conditional approval, it **must first** pass review by the Regenerative Medicine Review Committee. The "must" here is not a suggestion but a legally mandatory procedure. Without the committee's review, no conditional approval can be granted. A subordinate rule adds one more number. Article 5 of the Organization and Operation Rules of the Regenerative Medicine Review Committee says: the committee convenes twice a year as a matter of principle, with extraordinary meetings held when necessary. Twice a year means that for a product going through conditional approval, the timeline has to count not only the review days but also when the committee happens to meet; miss one, and in principle you wait half a year. The same article also requires members to attend in person without appointing proxies, and a meeting requires a quorum of more than half of all members. All of these affect the timeline, but they are meeting-operation rules, written into the subordinate regulation rather than the review timetable, so you have to look them up yourself. Article 7 of the same rules has another provision worth remembering: the preparatory work for the review, the review process, and the names of members and expert scholars are restricted from disclosure under the Freedom of Government Information Law, and only the meeting minutes are disclosed. This is so members can review without interference, so the submitting party will not receive the list; you need to know about this provision when planning. As for a medical institution performing a regenerative medicine technique, the approval authority rests with the central competent authority, and on that line the committee has only an advisory role. I have [already worked through the threshold, the five-year validity, and the non-renewability of conditional approval itself in piece 3](/en/articles/taiwan-conditional-approval-trmat-pathway/), and will not repeat it here. ## So on what basis does the CDE review your case? **The answer is not in the Regenerative Medicine Act but in the Administrative Procedure Act.** The CDE is a juridical person delegated by the Ministry of Health and Welfare to carry out professional review under Article 16 of the Administrative Procedure Act; neither law directly establishes it. That it is unnamed in the two laws does not mean it has no legal basis. Article 16, Paragraph 1: an administrative agency may, in accordance with laws and regulations, delegate part of its powers to a private body or individual. The CDE is the "private body" in this provision. It is a nonprofit foundation established in July 1998 with funding from the Department of Health, Executive Yuan (the predecessor of the Ministry of Health and Welfare), and it has no establishment act of its own. This arrangement has its logic: the substance of professional review shifts with scientific progress, and configuring it through delegation is more flexible than amending the organization law every time. Article 16 of the Administrative Procedure Act provides exactly that flexibility. Article 16 has three key phrases that almost entirely determine the CDE's legal standing: "in accordance with laws and regulations," "part of its powers," and "delegate." "In accordance with laws and regulations" means that the Administrative Procedure Act alone is not enough; there also has to be authorization in a specific operative law as the basis. Those authorizations do exist in the two laws: Article 12, Paragraph 2 of the Regenerative Medicine Act (technique approval), Article 14, Paragraph 3 (cell-processing inspection permit), Article 18, Paragraph 4 (cell-bank permit), and the two provisions on advertising approval (Article 22, Paragraph 2 of the Regenerative Medicine Act and Article 15, Paragraph 2 of the Products Act). "Part of its powers" means it cannot all be delegated out as a bundle. And the most critical thing is the subject of the verb "delegate." Reading the first three provisions one by one, the sentence structure is identical to the letter: "the central competent authority may entrust its subordinate agencies, or delegate to other agencies (institutions), juridical persons, or bodies, to handle" the matter. The two advertising provisions are worded slightly differently, using "the central competent authority or the agencies (institutions) or juridical persons it has entrusted or delegated," which presupposes the existence of delegation rather than granting the power to delegate, but the logic is the same. In other words, what the law authorizes is that the Ministry of Health and Welfare may delegate, not a direct authorization of the CDE. This is also the biggest difference in the legal standing of the three units. TFDA and the Department of Medical Affairs take on authority that the law directly assigns; the CDE receives authorization that the Ministry of Health and Welfare has carved out of its own powers and delegated. The law only says "may delegate to a juridical person"; it does not say to whom. ## Why can't the CDE approve? Not because it is a foundation Many people assume the CDE cannot approve because it is a nonprofit foundation. That is not the reason. Article 2, Paragraph 3 of the Administrative Procedure Act provides: an individual or body entrusted with the exercise of public authority is, **within the scope of that delegation, treated as an administrative agency**. In other words, the law does not prohibit the CDE from exercising public authority. The reason the CDE has no approval power today is not that it is a foundation, but that the scope the Ministry of Health and Welfare currently delegates to it reaches only technical review and consultation. The scope can be changed; the law does not block it. This distinction matters a great deal in practice. When you ask the CDE, what you get back is an opinion. That opinion carries great weight and can determine whether you spend tens of millions moving forward, but it is not an administrative disposition. If you want to contest the final result, the party you contest is the competent authority that made the disposition, not the entrusted body that issued the opinion. When planning a timeline, "the CDE gave a favorable opinion" and "the competent authority approved it" have to be treated as two things. ## How do you check the delegation notices? The product side is findable; the technique side I have not found **First the conclusion: the delegation basis on the product side is easy to find; a new notice on the technique side after the two laws took effect, I have not yet found.** Article 16, Paragraph 2 of the Administrative Procedure Act gives a handle you can check yourself: when delegating, the agency must announce the delegated matters and the legal basis, and publish this in the government gazette or a newspaper. In other words, exactly what the Ministry of Health and Welfare has delegated to the CDE is, in principle, findable. The product-side line is clear. Since April 30,2018, TFDA has delegated to the CDE the technical document review of drug clinical trial protocols, registration, and the like. The CDE itself, in February 2026, even announced the results statistics for the 2025 technical data evaluation of IND, BSE, and NDA submissions carried out under TFDA's delegation, proving that this delegation is still running. And because Article 3, Paragraph 2 of the Regenerative Medicine Products Act has already characterized regenerative medicine products as drugs under Article 6 of the Pharmaceutical Affairs Act, this older delegation naturally covers them. Since regenerative medicine products are drugs by law, the delegation originally meant for drug technical review also applies to regenerative medicine products. **This cell is filled.** The technique side takes more work. What you can find is the cell therapy technique guidance announced in Notice Wei-Bu-Yi-Zi No. 1081660965A (March 7, 2019), which states that the review of cell therapy techniques is administered by the Ministry of Health and Welfare and delegated to the Center for Drug Evaluation foundation to handle related matters, with later revisions through the January 2022 version. The CDE's own website also says it accepts delegation from the Ministry of Health and Welfare to carry out review work. The problem is that the legal basis of that delegation is the Special Management Regulations, and those have sunset along with the entry into force of the two laws. I did find one other technique-side delegation notice from the new-law era: Notice Wei-Bu-Yi-Zi No. 1151662584 (March 30, 2026), which delegates, under the Regulations for the Management of Regenerative Medicine Techniques and Designated Products, the certification work for clinic-based regenerative medicine. But the entrusted body in that notice is the Joint Commission of Taiwan, not the CDE. As for whether, after the two laws took effect, the Ministry of Health and Welfare has again announced a delegation of regenerative medicine technique review to the CDE, I have not found it. Not finding it does not mean it does not exist; the notice may be tucked away in some corner I did not turn over. But leaving this cell honestly blank is more truthful than filling it with an answer I inferred. ## Why it is so hard to match a document back to its legal basis In the course of our dealings with the competent authority this year, we sent over questions about GMP and GTP, and the reply we got was that this was not within their jurisdiction and that we should ask TFDA. In the same reply, they cited the CDE's opinion on what level the clinical trial stage should reach. There is nothing wrong with the reply itself; the two matters each have their own basis. Manufacturing standards for products belong to the Pharmaceutical Affairs Act framework and were never on the medical technique line, so pushing them back to TFDA follows the law. The CDE's opinion shows up here because it serves both sides, and what it gives is an opinion rather than an approval or rejection to begin with. The difficulty lies elsewhere. A document answers you only within its own scope of authority; it will not also explain which cell the matter it pushed away and the opinion it cited each belong to. This is no one's oversight; documents are simply written this way, and each unit can speak only to the part it governs. But it means that no one is obligated to assemble the cross-unit map for you; you have to go back and read the statutes and notices one by one. That is what this map does. ## Where the power comes from decides whom you should ask **What this map really draws is where each unit's power comes from, not who is more important than whom.** The powers of TFDA and the Department of Medical Affairs are written into law, and changing them requires amending the law. The CDE's powers come from administrative delegation, and can be adjusted through a notice. This difference directly affects two things: whom a document should go to, and what the answer you get back represents. Send a question that was really just for a technical opinion to the competent authority, and what you usually get is a procedural reply; conversely, treat the CDE's technical opinion as the competent authority's approval, and you will still fail to clear the formal approval or rejection in the end. Half a year into the two laws, the CDE's position on the product side has the Pharmaceutical Affairs Act behind it and is stable; if you really want to confirm the technique side, asking the handling unit directly is faster than inferring it back from public records. I only wanted to know where a document should go, and ended up redrawing the entire authority structure. There is still a blank cell on the technique side; for now I cannot find a delegation notice from the new-law era, and rather than guess, I will leave it empty. Once I find it, I will fill it in.