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檢送「115年實驗室生物安全查核基準(草案)」，請依說明段辦理。
一、依據「感染性生物材料管理辦法」(以下稱管理辦法)第28條及第42條暨衛
生福利部疾病管制署(下稱疾管署)115年1月20日疾管感字第1150500015號
函辦理。
二、旨揭查核基準(草案)依受查對象分為以下類別：
(一)高防護實驗室(BSL-3/ABSL-3/BSL-4實驗室)/第三級危險群(RG3)病原體
保存場所/結核病(TB)負壓實驗室之設置單位生物安全管理組織查核基
準(附件1)；
(二)高防護實驗室、RG3病原體保存場所、TB負壓實驗室之生物安全查核基
準(附件2-4)；
(三)管制作業場所之生物安全查核基準(附件5)；
(四)BSL-2/ABSL-2實驗室及RG2病原體保存場所之設置單位生物安全管理組
織查核基準(附件6)；
(五)BSL-2/ABSL-2實驗室及RG2病原體保存場所之生物安全查核基準(附件7
-8)。
三、鑑於管理辦法修正草案業於114年完成預告程序，預訂將於115年公告施行
，有關前述基準草案之評量說明及參考依據所列管理辦法條次，係依疾管
署114年5月9日預告之管理辦法草案條次進行說明。
四、前述基準草案係參考各縣市衛生局、國內設置單位及相關公協會團體修正
意見，並經實驗室生物安全查核基準研修小組會議決議通過後，公布於疾
管署全球資訊網(網址：www.cdc.gov.tw)之「首頁＞傳染病與防疫專題＞
實驗室生物安全＞實驗室生物安全查核作業＞115年實驗室生物安全查核
基準研修意見徵詢作業」專區項下。
五、貴單位如對前揭基準草案內容有任何意見或修正建議，請於115年2月2日
前，填寫附件9「實驗室生物安全查核基準研修意見表」，免備文，以電
子郵件逕寄至疾管署承辦人員電子郵件信箱(bchou@cdc.gov.tw)，信件主
旨並敘明為「實驗室生物安全查核基準研修意見回復」，以利彙辦；無意
見者請免回復。
<<ENGLISH_ANNOUNCEMENT_CONTENT>>
Enclosed please find the "Draft Laboratory Biosafety Inspection Criteria for 2026." Please proceed in accordance with the instructions provided.
1. This notice is issued in accordance with Article 28 and Article 42 of the "Regulations for the Management of Infectious Biological Materials" (hereinafter referred to as the "Regulations"), as well as a letter dated January 20, 2026, No. 1150500015, issued by the Centers for Disease Control (hereinafter referred to as the "CDC") under the Ministry of Health and Welfare.
2. The draft inspection criteria are categorized according to the inspected entities as follows:
(1) Biosafety Management Organization Inspection Criteria for High-Containment Laboratories (BSL-3/ABSL-3/BSL-4 Laboratories) / Facilities Storing Risk Group 3 (RG3) Pathogens / Tuberculosis (TB) Negative Pressure Laboratories (Attachment 1);
(2) Biosafety Inspection Criteria for High-Containment Laboratories, Facilities Storing RG3 Pathogens, and TB Negative Pressure Laboratories (Attachments 2–4);
(3) Biosafety Inspection Criteria for Containment Workplaces (Attachment 5);
(4) Biosafety Management Organization Inspection Criteria for BSL-2/ABSL-2 Laboratories and Facilities Storing RG2 Pathogens (Attachment 6);
(5) Biosafety Inspection Criteria for BSL-2/ABSL-2 Laboratories and Facilities Storing RG2 Pathogens (Attachments 7–8).
3. As the draft amendments to the Regulations have completed the public consultation process in 2025, it is anticipated that the revised Regulations will be officially announced and implemented in 2026. The references to the relevant articles of the Regulations in the draft criteria are based on the draft amendments announced by the CDC on May 9, 2025.
4. The draft criteria have been revised in light of opinions and suggestions received from local health bureaus, domestic entities, and relevant public and professional associations. After approval by the Laboratory Biosafety Inspection Criteria Revision Working Group, the draft criteria have been published on the CDC's official website (URL: www.cdc.gov.tw) under the section "Home > Infectious Diseases and Prevention > Laboratory Biosafety > Laboratory Biosafety Inspection Operations > 2026 Laboratory Biosafety Inspection Criteria Public Consultation."
5. If your unit has any comments or suggestions regarding the draft criteria, please complete Attachment 9, the "Laboratory Biosafety Inspection Criteria Revision Comments Form," and submit it directly via email to the CDC contact person at bchou@cdc.gov.tw by February 2, 2026. Please note "Laboratory Biosafety Inspection Criteria Revision Comments" in the subject line of your email for ease of processing. If you have no comments, there is no need to reply.
Respectfully,
[Taiwan Buddhist College Office of Administration] |
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