Administrative Measures for the Approval of Laboratory Activities Involving Highly Pathogenic Human-Transmissible Microorganisms
Administrative Measures for the Approval of Laboratory Activities Involving Highly Pathogenic Human-Transmissible Microorganisms
Administrative Measures for the Approval of Laboratory Activities Involving Highly Pathogenic Human-Transmissible Microorganisms
Order of the National Health Commission No. 14
April 21, 2025
The Administrative Measures for the Approval of Laboratory Activities Involving Highly Pathogenic Human-Transmissible Microorganisms, adopted at the first executive meeting on March 31, 2025, are hereby issued and shall come into effect on July 1, 2025.
Lei Haichao, Director
Administrative Measures for the Approval of Laboratory Activities Involving Highly Pathogenic Human-Transmissible Microorganisms
Chapter I General Provisions
Article 1 The Administrative Measures for the Approval of Laboratory Activities Involving Highly Pathogenic Human-Transmissible Microorganisms (hereinafter referred to as the "Measures") are formulated in accordance with the Biosecurity Law of the People's Republic of China and the Administrative Regulations on the Bio-safety of Pathogenic Microbe Laboratories to strengthen the biosafety management of pathogenic microbe laboratories (hereinafter referred to as the "laboratories") and regulate laboratory activities involving highly pathogenic microorganisms.
Article 2 The Measures shall apply to the approval of laboratory activities involving highly pathogenic human-transmissible microorganisms (hereinafter referred to as "highly pathogenic microorganisms") or suspected highly pathogenic microorganisms, as specified in the Catalog of Pathogenic Human-transmissible Microorganisms (hereinafter referred to as "the Catalog"), when such activities are conducted in Biosafety Level 3 or Level 4 (BSL-3/4) laboratories and are required by the Catalog to be performed at these levels.
Article 3 For the purposes of the Measures, highly pathogenic or suspected highly pathogenic microorganisms include Class I and Class II pathogenic microorganisms published in the Catalog issued by the competent health authority under the State Council and pathogenic microorganisms managed under Class I or Class II, as well as other highly pathogenic or suspected highly pathogenic microorganisms related to human health that are not listed in the Catalog.
Article 4 The competent health authority under the State Council is responsible for the supervision and regulation of the approval of laboratory activities in BSL-3/4 laboratories nationwide.
Local competent health authorities at the county level or above are responsible for supervising and regulating the biosafety of BSL-3/4 laboratory activities within their respective administrative regions.
Chapter II Approval of Laboratory Activities
Article 5 BSL-3/4 laboratories seeking to conduct laboratory activities involving highly pathogenic microorganisms that are required by the Catalog to be performed at these levels must obtain approval from the competent health authorities at the provincial level or above.
For BSL-4 laboratories applying to conduct laboratory activities involving highly pathogenic microorganisms or for BSL-3 laboratories applying to conduct laboratory activities involving Class I pathogenic microorganisms and those managed under Class I, the approval must be obtained from the competent health authority under the State Council.
BSL-3 laboratories applying to conduct laboratory activities involving Class II pathogenic microorganisms and those managed under Class II must obtain approval from the provincial competent health authorities.
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Order of the National Health Commission No. 14
April 21, 2025
The Administrative Measures for the Approval of Laboratory Activities Involving Highly Pathogenic Human-Transmissible Microorganisms, adopted at the first executive meeting on March 31, 2025, are hereby issued and shall come into effect on July 1, 2025.
Lei Haichao, Director
Administrative Measures for the Approval of Laboratory Activities Involving Highly Pathogenic Human-Transmissible Microorganisms
Chapter I General Provisions
Article 1 The Administrative Measures for the Approval of Laboratory Activities Involving Highly Pathogenic Human-Transmissible Microorganisms (hereinafter referred to as the "Measures") are formulated in accordance with the Biosecurity Law of the People's Republic of China and the Administrative Regulations on the Bio-safety of Pathogenic Microbe Laboratories to strengthen the biosafety management of pathogenic microbe laboratories (hereinafter referred to as the "laboratories") and regulate laboratory activities involving highly pathogenic microorganisms.
Article 2 The Measures shall apply to the approval of laboratory activities involving highly pathogenic human-transmissible microorganisms (hereinafter referred to as "highly pathogenic microorganisms") or suspected highly pathogenic microorganisms, as specified in the Catalog of Pathogenic Human-transmissible Microorganisms (hereinafter referred to as "the Catalog"), when such activities are conducted in Biosafety Level 3 or Level 4 (BSL-3/4) laboratories and are required by the Catalog to be performed at these levels.
Article 3 For the purposes of the Measures, highly pathogenic or suspected highly pathogenic microorganisms include Class I and Class II pathogenic microorganisms published in the Catalog issued by the competent health authority under the State Council and pathogenic microorganisms managed under Class I or Class II, as well as other highly pathogenic or suspected highly pathogenic microorganisms related to human health that are not listed in the Catalog.
Article 4 The competent health authority under the State Council is responsible for the supervision and regulation of the approval of laboratory activities in BSL-3/4 laboratories nationwide.
Local competent health authorities at the county level or above are responsible for supervising and regulating the biosafety of BSL-3/4 laboratory activities within their respective administrative regions.
Chapter II Approval of Laboratory Activities
Article 5 BSL-3/4 laboratories seeking to conduct laboratory activities involving highly pathogenic microorganisms that are required by the Catalog to be performed at these levels must obtain approval from the competent health authorities at the provincial level or above.
For BSL-4 laboratories applying to conduct laboratory activities involving highly pathogenic microorganisms or for BSL-3 laboratories applying to conduct laboratory activities involving Class I pathogenic microorganisms and those managed under Class I, the approval must be obtained from the competent health authority under the State Council.
BSL-3 laboratories applying to conduct laboratory activities involving Class II pathogenic microorganisms and those managed under Class II must obtain approval from the provincial competent health authorities.
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