感染性生物材料管理辦法

These Regulations are enacted pursuant to Paragraph 3, Article 34 of the Communicable Disease Control Act (hereafter referred to as “the Act”).

1The terms used in these Regulations are defined as follows:

21. “Infectious biological materials” refers to infectious pathogens or derivatives thereof mentioned in Paragraph 4, Article 4 of the Act, and substances confirmed to contain such pathogens or derivatives.

32. “Entity” refers to an organization, institution, school, legal person or group that possesses, stores, uses, disposes of, or imports and exports infectious biological materials and has set up a laboratory or storage facility therefor.

43. “Laboratory” refers to a facility that uses infectious biological materials to conduct experimental operations for testing or research purposes.

54. “Storage facility” refers to a facility that stores or disposes of infectious biological materials.

65. “Biosafety” refers to safeguard measures implemented to protect personnel from accidental exposure to or prevent leakage of infectious biological materials.

76. “Biosecurity” refers to protective and management measures implemented to prevent unauthorized access, loss, theft, abuse, transfer or leakage of infectious biological materials.

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1Pathogens are classified into four risk groups by the hazardous level of their pathogenicity:

21. Risk Group 1: such as Escherichia coli K-12, Adeno-associated virus and other pathogens that usually do not affect human health;

32. Risk Group 2: such as Staphylococcus aureus, Hepatitis B virus, Plasmodium falciparum, and other pathogens that could produce mild effects on human health, and for which preventive or therapeutic interventions are usually available;

43. Risk Group 3: such as Mycobacterium tuberculosis, Human immunodeficiency virus type 1 and type 2, and other pathogens that could produce serious effects on human health or may even be fatal, and for which preventive or therapeutic interventions are likely available;

54. Risk Group 4: such as Ebola virus, Variola (major and minor) virus, and other pathogens that could produce serious effects on human health or may even be fatal, and for which preventive or therapeutic interventions are usually not available.

1Pathogens in Risk Groups 2-4, biotoxins and positive specimens that may pose a severe hazard to public health and safety due to abuse or leakage shall be classified as biological select agents and toxins (hereafter referred to as “BSAT”).

2Laboratories and storage facilities that possess, store, use, or dispose of BSAT are classified as controlled premises.

3The directions for the subtypes, types, total quantity control, packaging, and other relevant matters governing BSAT, pathogens and biotoxins other than BSAT, as well as positive specimens, shall be prescribed by the central competent authority.

Laboratories that conduct animal experiments are referred to as “animal biosafety laboratories,” while all other laboratories are referred to as “biosafety laboratories.”

1Biosafety laboratories, by their operational practices, barriers, and safety equipment and facilities, are classified into four biosafety levels (BSL); the biosafety levels of laboratories and the infectious biological materials the laboratories may work with are as follows:

21. Level 1 (BSL-1): may work with infectious biological materials that usually do not affect human health.

32. Level 2 (BSL-2): may work with infectious biological materials that could affect human health, and for which preventive or therapeutic interventions are usually available.

43. Level 3 (BSL-3): may work with infectious biological materials that could produce serious effects on human health or may even be fatal, and for which preventive or therapeutic interventions are likely available.

54. Level 4 (BSL-4): may work with infectious biological materials that could produce serious effects on human health or may even be fatal, and for which preventive or therapeutic interventions are usually not available.

1Animal biosafety laboratories, by their operational practices, barriers, and safety equipment and facilities, are classified into four animal biosafety levels (ABSL); the biosafety levels of laboratories and the infectious biological materials the laboratories may work with for animal experiments are as follows:

21. Level 1 (ABSL-1): may work with infectious biological materials that usually do not affect human health.

32. Level 2 (ABSL-2): may work with infectious biological materials that could affect human health, and for which preventive or therapeutic interventions are usually available.

43. Level 3 (ABSL-3): may work with infectious biological materials that could produce serious effects on human health or may even be fatal, and for which preventive or therapeutic interventions are likely available.

54. Level 4 (ABSL-4): may work with infectious biological materials that could produce serious effects on human health or may even be fatal, and for which preventive or therapeutic interventions are usually not available.

1Level 3 and Level 4 biosafety laboratories and animal biosafety laboratories are considered high-containment laboratories.

2The directions for operational practices, barriers, safety equipment and facilities of laboratories mentioned in the preceding two articles shall be prescribed by the central competent authority.

1An entity shall establish a biosafety and biosecurity management mechanism for infectious biological materials. For infectious biological materials that involve pathogens in Risk Groups 2-4 or biotoxins, the entity shall establish biosafety, biosecurity and emergency response plans in accordance with the items set forth by the central competent authority.

2Prior to possessing, storing, using, disposing of or importing and exporting pathogens in Risk Groups 2-4 or biotoxins, an entity shall appoint a biosafety officer (hereinafter referred to as “BSO”) and an alternate; an entity with thirty personnel or more shall also set up an institutional biosafety committee (hereinafter referred to as “IBC”). The BSO appointment and IBC setup must be reported to and approved by the local competent authority before the entity may proceed to possess, store, use, dispose of, or import and export pathogens in Risk Groups 2-4 or biotoxins; the same shall apply to any changes thereafter.

3Prior to possessing, storing, using, disposing of or importing and exporting pathogens or biotoxins mentioned in the preceding paragraph that are classified as BSAT, an entity shall additionally appoint a BSAT officer and an alternate. The appointment must be reported to and approved by the central competent authority before the entity may proceed to possess, store, use, dispose of, or import and export the aforementioned pathogens or biotoxins; the same shall apply to any changes thereafter.

4The BSAT officer and the BSO shall not be the same person. However, the same person may serve concurrently as both the BSAT officer and the BSO, provided the entity does not possess, store, use, dispose of or import and export non-BSAT.

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1In any of the following circumstances, an entity shall notify the local competent authority and request that the following actions be taken:

21. When an entity has fewer than thirty personnel, the approval of its IBC shall be rescinded.

32. When an entity no longer has a need to possess, store, use, dispose of, or import and export pathogens in Risk Groups 2-4 or biotoxins, the approval of its BSO and IBC shall be rescinded.

4When an entity no longer has a need to possess, store, use, dispose of, or import and export BSAT, it shall notify the central competent authority and request rescission of the approval of its BSAT officer.

5When the competent authority finds that an entity falls under any of the following circumstances, it may revoke or rescind the approval for the entity’s BSO, IBC or BSAT officer:

61. The documents or information submitted by the entity for approval contain false or misleading representations.

72. The entity with an IBC set up has less than thirty personnel.

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1An entity’s BSO and BSAT officer shall be served by the entity’s personnel with professional knowledge and competence in biosafety and biosecurity related fields, who may start acting as the BSO or BSAT officer after attending training courses for biosafety management personnel organized by the central competent authority or an accredited training institution and obtaining a qualification certificate.

2For entities meeting all the following criteria, their BSOs who have been approved by the local competent authority before the amendments to these Regulations take effect on April 30, 2026 may obtain the qualification required under the preceding paragraph within two years from the effective date of that amendments and, during that period, shall not be subject to the restrictions set out in the preceding paragraph:

31. The entity does not possess, store, use, dispose of, or import and export pathogens in Risk Groups 3-4, or any BSAT; and

42. The entity has not set up a high-containment laboratory.

1Duties of the BSO are as follows:

21. Act as the contact person of the entity for external communication of biosafety and biosecurity matters;

32. Provide consultation on biosafety and biosecurity matters of laboratories and storage facilities;

43. Review the applications of laboratories and storage facilities for possession, storage, use, disposition, or import and export of pathogens in Risk Groups 2-4 or biotoxins;

54. Supervise the implementation of biosafety and biosecurity training of personnel by laboratories or storage facilities;

65. Supervise the internal audits of biosafety and biosecurity of laboratories and storage facilities every year, and report the audit results to the IBC;

76. Supervise the implementation of personnel competence evaluation by high-containment laboratories or laboratories and storage facilities that store or use pathogens in Risk Groups 3-4;

87. Supervise the biorisk management system operations of high-containment laboratories or laboratories and storage facilities that store or use pathogens in Risk Groups 3-4;

1Duties of the BSAT officer are as follows:

21. Act as the contact person of the entity for external communication of BSAT matters;

32. Provide consultation and anonymous reporting channels at the controlled premises;

43. Review the applications of controlled premises for possession, storage, use, disposition, or import and export of BSAT;

54. Designate personnel to undertake the tasks of possessing, storing, using, disposing of, or importing and exporting BSAT, or terminate such designations, and report to the IBC for consent;

65. Supervise the pre-employment and ongoing suitability assessment of personnel with access to BSAT;

76. Supervise the internal audits of biosafety and biosecurity of controlled premises every year, and report the audit results to the IBC;

87. Supervise the implementation of BSAT, biosafety and biosecurity training as well as competence evaluation of personnel by controlled premises;

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1The term of the designated personnel mentioned in Subparagraph 4 of the preceding article shall not exceed three years; upon expiration of the term or any change in the designated personnel, a new designation shall be made.

2Only the BSAT officer and his/her alternate, and designated personnel mentioned in the preceding paragraph are authorized to possess, store, use, dispose of, and import and export BSAT.

3When a person mentioned in the preceding paragraph falls under any of the following circumstances, the entity shall immediately terminate the person’s authorization granted under the preceding paragraph and report the matter to the central competent authority for record:

41. Has seriously violated biosafety or biosecurity management regulations;

52. Is suspected of participating in a domestic or foreign bioterrorism activity; or

63. Has committed other related crimes.

1The IBC shall have several members. The head or deputy head of the entity shall act as the chairperson, whereas the BSO and BSAT officer are ex officio members of the committee, and the other members shall include personnel mentioned in the following subparagraphs:

21. A representative of laboratory or storage facility directors.

32. A representative of laboratory or storage facility managers.

43. A representative of biosafety or biosecurity related engineering technicians or other personnel with relevant professional knowledge.

5The IBC shall meet at least once every six months, and when necessary, may call special meetings.

6The meetings in the preceding paragraph shall be called and chaired by the IBC chairperson; when unable to attend a meeting, the chairperson may designate a member to act on his/her behalf.

1Duties of the IBC are as follows:

21. Establish biosafety and biosecurity management policies of the entity;

32. Review the biosafety level of laboratories;

43. Review the applications of laboratories and storage facilities for possession, storage, use, disposition, and import and export of pathogens in Risk Groups 2-4, biotoxins, or BSAT;

54. Review biosafety, biosecurity and emergency response plans;

65. Review the plans for construction, alteration, expansion, inauguration, temporary shutdown, downgrade or closure of laboratories and storage facilities;

76. Review matters concerning disputes over the entity’s biosafety or biosecurity issues;

87. Review the health monitoring mechanism for laboratory or storage facility personnel;

98. Conduct pre-employment and ongoing suitability assessment of the BSAT officer and his/her alternate;

1The possession, storage, use, disposition or transfer of pathogens in Risk Groups 2-4 or biotoxins must be reviewed and approved by the BSO, and in addition, reviewed and approved by the IBC if the entity has an IBC set up.

2Where the pathogens or biotoxins in the preceding paragraph are BSAT, their possession, storage, use, disposition or transfer must be reviewed and approved by the BSAT officer and the IBC, and those activities can only be performed at controlled premises whose inauguration has been approved by the central competent authority.

3The possession, storage, new addition or transfer of pathogens mentioned in Paragraph 1 hereof that are classified in Risk Groups 3 or 4, or BSAT mentioned in the preceding paragraph shall not commence until the entity has reported to and obtained approval from the central competent authority; when the entity removes an above-mentioned infectious biological material from its inventory, it shall report it to the central competent authority for record within thirty days following the removal.

4Regarding the transfer mentioned in Paragraph 1 and Paragraph 2 hereof, the recipient must be an entity that has already reported to and obtained approval from the competent authority according to Paragraph 2 or 3 of Article 9 herein, and the transfer has been reviewed and approved by its IBC prior to receipt.

5The recipient of transferred BSAT shall, within three days from the day following the receipt of BSAT, report the receipt to the central competent authority for record.

1If a laboratory detects pathogens in Risk Groups 2-4 or biotoxins while conducting clinical or research testing or participating in proficiency testing, it shall, within the following time period, destroy, store, or transfer the detected pathogens or biotoxins to an entity that has obtained approval pursuant to Paragraph 2 or Paragraph 3 of Article 9 herein:

21. Clinical or research testing: Within thirty days from the day following detection.

32. Proficiency testing: Within ninety days from the day following detection.

4If the detected pathogens or biotoxins in the preceding paragraph are BSAT and have not been approved for possession, storage or use according to Paragraph 2 of the preceding article, the laboratory shall report the plan for their destruction, storage or transfer to the central competent authority for record within seven days from the day following detection, and then complete such handling within the time limit specified in the preceding paragraph.

1For the import and export of infectious biological materials, an entity shall submit an application and relevant documents to the central competent authority for approval according to Paragraph 2, Article 34 of the Act.

2In the event that infectious biological materials to be imported or exported in the preceding paragraph are pathogens in Risk Groups 2-4 or biotoxins, their import and export must be reviewed and approved by the BSO, and in addition, reviewed and approved by the IBC if the entity has an IBC set up.

3In the event that infectious biological materials to be imported or exported in Paragraph 1 hereof are BSAT, their import and export must be reviewed and approved by the BSAT officer and the IBC, and consent documents from the IBC of the entity shall be enclosed with the application.

1Storage facilities that store pathogens in Risk Groups 2-4 or biotoxins shall carry out the following:

21. Assign a person to take charge of storage management;

32. Establish access control and implement proper security mechanisms for storage facilities and equipment;

43. Post the names and contact numbers of the storage facility director and manager, as well as emergency contact information in a conspicuous place at personnel entrances and exits;

54. Keep an inventory list and records of storage and retrieval;

65. Make biosecurity related management manuals available on site; and

76. Take periodic inventories of items in stock and their quantities or weights.

1Level 2 to 4 laboratories shall carry out the following:

21. Assign a person to take charge of management matters;

32. Establish access control;

43. Post the biosafety level, biohazard symbols, names and contact numbers of the laboratory director and manager, as well as emergency contact information in a conspicuous place at personnel entrances and exits;

54. Keep a list of items handled and related handling records;

65. Make laboratory biosafety management manuals available on site; and

76. Take periodic inventories of items handled and their quantities or weights.

8For laboratory personnel who work with pathogens in Risk Groups 3 or 4, an entity shall keep their serum specimens for ten years after they have left the job. For laboratory personnel who work with pathogens in Risk Group 2, the necessity of retaining their serum specimens and retention period shall be decided by the entity’s IBC.

1High-containment laboratories, controlled premises, or other laboratories and storage facilities that store or use pathogens in Risk Groups 3 or 4 shall establish a biorisk management system.

2Implementation guidelines for the establishment of a biorisk management system in the preceding paragraph shall be prescribed by the central competent authority.

1A newly established high-containment laboratory or controlled premises may be inaugurated only after being reviewed and approved by the entity’s IBC and obtaining approval from the central competent authority by submitting an application along with relevant documents and information; the same shall apply to change of its location, address or scope of operating area.

2When a high-containment laboratory or controlled premises falls under any of the following circumstances, the central competent authority may revoke or rescind its approval:

31. The document or information submitted for approval contain false or misleading representations.

42. The high-containment laboratory has ceased operation for more than one year.

53. The controlled premises have not possessed, stored, used, disposed of, imported or exported BSAT for more than one year.

64. The approval of the BSO, IBC or BSAT officer of the entity to which the laboratory or controlled premises belongs has been cancelled, revoked, or rescinded.

75. The entity to which the laboratory or controlled premises belongs has been merged downsized, dissolved, or ceased business, or its establishment or registration permit has been revoked or rescinded.

1The following personnel shall, depending on the nature of their work, receive continuing education on biosafety and biosecurity:

21. BSO and alternate: At least 8 hours annually.

32. BSAT officer and alternate: At least 8 hours annually, plus at least 4 additional hours of BSAT-related courses.

43. IBC members: At least 2 hours annually.

54. Personnel working at laboratories or storage facilities: For personnel whose work involves pathogens in Risk Groups 2-4 or biotoxins, at least 8 hours annually for new personnel, and at least four hours annually for existing personnel; for personnel whose work does not involve the aforementioned pathogens or biotoxins, their hours of continuing education courses will be decided by the entity.

65. Personnel working at controlled premises: Personnel working at controlled premises shall receive continuing education in accordance with the hourly requirements set forth in the preceding subparagraph. In addition, they shall complete at least one hour of BSAT-related courses and at least one hour of safety awareness training.

76. Other personnel designated by the central competent authority: The continuing education courses and hours required shall be determined by the central competent authority.

1Laboratories and storage facilities shall establish emergency response procedures in accordance with the emergency response plan specified in Paragraph 1 of Article 9 herein.

2The laboratories and storage facilities mentioned in the preceding paragraph shall conduct an emergency response drill annually, and a field drill at least once every three years.

1Laboratories and storage facilities shall safekeep records on the inventory, disposition, biosafety or biosecurity incidents, personnel training, and other relevant activities in connection with pathogens in Risk Groups 2-4 and biotoxins for at least three years.

2Controlled premises shall safekeep records on the inventory, personnel training, and other relevant activities in connection with BSAT for at least three years, and records on disposition, biosafety or biosecurity incidents for at least ten years.

1The transport of infectious biological materials shall meet the triple packaging rules set forth by the central competent authority, use appropriate vehicles, and comply with the rules and regulations set forth by the central transportation and communications authority.

2In the event of an incident involving infectious biological materials during the course of transport, carrier shall promptly notify the consigning entity and undertake necessary emergency measures. Upon receiving such notice, the consigning entity shall immediately notify the local competent authority where the incident occurs and the central competent authority through the established system or by other appropriate means.

1In the event of a biosecurity incident, a laboratory or storage facility shall promptly inform its BSO, and controlled premises shall promptly inform their BSAT officers.

2Where the incident in the preceding paragraph involves an inconsistency in the item or quantity of stored or transferred Risk Group 2 pathogens or biotoxins other than BSAT, and involves loss, theft, or unknown cause, the entity shall report to the local competent authority for record within seven days from the day following confirmation of the investigation results.

3Where the incident in Paragraph 1 hereof involves pathogens in Risk Groups 3 or 4, or BSAT, the entity shall report to the competent authorities at all levels within the following timeframe:

41. Pathogens in Risk Groups 3 or 4: Within three days from the day following the receipt of a report by the BSO.

52. BSAT: Within three days from the day following the receipt of a report by the BSAT officer.

6With regard to an incident mentioned in the preceding paragraph, the entity shall, within ten days from the day following the discovery of the incident, submit a preliminary investigation report reviewed by its IBC to the competent authorities at all levels for record. In addition, the entity shall, within thirty days from the day following the discovery of the incident, submit an incident investigation report as well as a correction and recovery plan reviewed by its IBC to the central competent authority for approval, with a copy of the same sent to the local competent authority.

1The biosafety incidents occurring at a laboratory or storage facility are classified into the following hazard levels by the extent of infectious biological material leakage or the status of personnel infection:

21. High:

3(1) A biosafety incident involving personnel at the laboratory or storage facility that leads to the infection of personnel; or

4(2) Leakage of infectious biological materials beyond the laboratory or storage facility that poses a risk of infection or harm to persons outside the laboratory or storage facility.

52. Moderate:

6(1) A biosafety incident at the laboratory or storage facility that poses a risk of infection or harm to personnel; or

7(2) Leakage of infectious biological materials confined to areas within the laboratory or storage facility that poses a risk of infection or harm to personnel.

83. Low: Leakage of infectious biological materials confined to the safety equipment within the laboratory or storage facility that poses a risk of infection or harm to personnel.

For the needs of disease prevention and control, the central competent authority may order an entity to destroy, place under seal, transfer custody of, or otherwise handle certain infectious biological materials in an appropriate manner within a given period of time.

1The competent authority may, for the needs of disease prevention and control, order high-containment laboratories, controlled premises, or laboratories and storage facilities that use and store pathogens in Risk Groups 2-4 or biotoxins, to provide relevant documents and information, and may conduct supervision and inspection thereof.

2When deficiencies are found in the supervision or inspection conducted pursuant to the preceding paragraph, the competent authority shall order the entity to take corrective actions within a given period of time; if the entity fails to comply accordingly, the competent authority may order the entity to discontinue the possession, storage, use, or disposition of relevant infectious biological materials, or suspend the operations of the aforementioned premises in part or in whole.

3Entities and their personnel may not evade, interfere with, or refuse the supervision, inspection, and actions taken by competent authorities under the preceding two paragraphs.

1Where a biosafety or biosecurity incident has occurred at a laboratory or storage facility, or where there is a risk of such an incident occurring, the competent authority may order the entity to discontinue the use or disposition of relevant infectious biological materials, or suspend the operations of the laboratory or storage facility in part or in whole.

2When the safety concern mentioned in the preceding paragraph has been resolved, and upon confirmation by the IBC of the entity, the entity may, after obtaining the consent of the competent authority, resume the use or disposition of infectious biological materials, or restore the operations of the laboratory or storage facility.

1For positive specimens that are not yet inactivated and to which P620 packing instructions apply for their transport in accordance with the World Health Organization’s Guidance on Regulations for the Transport of Infectious Substances, the provisions governing pathogens in Risk Groups 3-4 under these Regulations shall apply to the management of their possession, storage, use, disposition, or import and export.

2The term “not yet inactivated” in the preceding paragraph means the positive specimen has not been treated with solvents, high temperatures, irradiation, or other effectively validated methods, such that it is still capable of causing human infection.

3For BSAT that are biotoxins whose quantity are below the control limits set forth by the central competent authority pursuant to Paragraph 3 of Article 4 herein, the provisions governing Risk Group 3 pathogens other than BSAT shall apply to their possession, storage, use, disposition, or import and export.

1An accredited training institution under Paragraph 1 of Article 11 herein must meet one of the following qualification requirements:

21. A government agency, government institution, or non-departmental public body.

32. An institution, legal person, or organization established or registered in accordance with applicable laws, whose functions or activities include the promotion of biosafety and biosecurity.

43. A school at the level of junior college or above that offers biosafety and biosecurity related courses and implements practical teaching on biosafety and biosecurity.

54. An entity approved by the competent authority pursuant to Paragraph 2 of Article 9 herein.

6To apply for accreditation, a training institution shall submit an application along with its training plan and other supporting documents and information to the central competent authority during the period announced by the central competent authority.

7After the application in the preceding paragraph has been reviewed and approved, the central competent authority shall issue a permit with a validity period of three years. An accredited training institution whose permit has expired shall resubmit an accreditation application to the central competent authority if it intends to continue the offering of training courses.

1Accredited training institutions shall comply with the following rules:

21. Conduct training courses for biosafety management personnel every year.

32. Assign or hire appropriate instructors, and provide suitable training venues and equipment.

43. Compile teaching materials in accordance with the outline set forth by the central competent authority, and form a review panel to review the materials.

54. Establish standards for fee collection and refunds, as well as service guidelines, and implement them accordingly.

65. Submit the annual training results to the central competent authority for record every year.

76. Carry out other matters announced by the central competent authority.

8The central competent authority may notify an accredited training institution to provide relevant documents and information, and may conduct supervision and inspection at the institution. The institution may not evade, interfere with, or refuse such request or action.

The central competent authority may commission or entrust relevant agencies, institutions, schools, legal persons, or organizations to carry out matters that the central competent authority is required to conduct pursuant to these Regulations.

These Regulations shall enter into force on the date of promulgation.