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

The terms used in these Regulations are defined as follows:
1. Entity: an organization (institution), group or enterprise that possesses, stores, uses, disposes of, or imports and exports infectious biological materials and has set up a laboratory or storage facility therefor.
2. Laboratory: a facility that conducts testing of communicable diseases or stores, uses, or disposes of infectious biological materials.
3. Storage facility: a facility other than laboratory that stores or disposes of infectious biological materials.
4. Biosafety: safeguard measures implemented to protect personnel from accidental exposure to or prevent leakage of infectious biological materials.
5. Biosecurity: protective and management measures implemented to prevent unauthorized access, loss, theft, abuse, transfer or leakage of infectious biological materials.
6. Disposal: the act of adding or removing infectious biological materials, or increasing or decreasing their quantities.

The pathogens referred to in Paragraph 4, Article 4 of the Act are classified into four risk groups by the hazardous level of their pathogenicity:
1. Risk Group 1: such as Escherichia coli K-12, Adeno-associated virus and others that do not affect human health;
2. Risk Group 2: such as Staphylococcus aureus, Hepatitis B virus, Plasmodium falciparum, and others that produce slight effects on human health and for which preventive or therapeutic interventions are available;
3. Risk Group 3: such as Mycobacterium tuberculosis, Human immunodeficiency virus type 1 and type 2, and others that can produce serious effects on human health, which may even be fatal and for which preventive or therapeutic interventions are often not available;
4. Risk Group 4: such as Ebola virus, Variola (major and minor) virus, and others that can produce serious effects on human health, which may even be fatal, and for which preventive or therapeutic interventions are not usually available.
The derivatives of the pathogens mentioned in Paragraph 4, Article 4 of the Act refer to the purified or isolated components of pathogens or their secretory products, including nucleic acids, plasmids, proteins, biotoxins or other derivatives.

The pathogens and biotoxins mentioned in the preceding article that may pose a severe hazard to public health and safety shall be classified as biological select agents and toxins (hereafter referred to as “BSAT”). BSAT that may cause a large number of injuries or deaths in people due to abuse or leakage shall be listed as “highly dangerous BSAT.”
The directions for the subtypes, types and packaging of the pathogens and biotoxins mentioned in the preceding article, BSAT mentioned in the preceding paragraph, and other relevant matters shall be prescribed by the central competent authority.

Laboratories that conduct animal experiments are referred to as “animal biosafety laboratory” whereas the other laboratories are referred to as “biosafety laboratory.”

Biosafety laboratories, by their operational practices, barriers, and safety equipment and facilities, are classified into four biosafety levels; the biosafety levels of laboratories and the infectious biological materials the laboratories may work with are as follows:
1. Level 1 (BSL-1): may work with infectious biological materials which do not cause disease in humans.
2. Level 2 (BSL-2): may work with infectious biological materials which could cause disease in humans.
3. Level 3 (BSL-3): may work with infectious biological materials which could cause serious or potentially lethal disease in humans.
4. Level 4 (BSL-4): may work with infectious biological materials which could cause severe to deadly disease in humans for which there are no available vaccines or treatments.

Animal biosafety laboratories, by their operational practices, barriers, and safety equipment and facilities, are classified into four animal biosafety levels; the biosafety levels of laboratories and the infectious biological materials the laboratories may work with for animal experiments are as follows:
1. Level 1 (ABSL-1): may work with infectious biological materials which do not cause disease in humans.
2. Level 2 (ABSL-2): may work with infectious biological materials which could cause disease in humans.
3. Level 3 (ABSL-3): may work with infectious biological materials which could cause serious or potentially lethal disease in humans.
4. Level 4 (ABSL-4): may work with infectious biological materials which could cause severe to deadly disease in humans for which there are no available vaccines or treatments.

The 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.