Module 9 2024

03/09/2024

Definition of Biotech Products - USA

USA (District of Columbia) Virus Serum and Toxin Act 1902

‘Viruses, serums, toxins and analogous products’

FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consisten t with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA) ‘A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product, protein (except any chemically synthesized polypeptide), or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings” (see section 351(i)(1) of the PHS Act).

Protein further defined : defines "protein" as "any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size." (See 21 CFR §600.3(h)(6)).

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Definition of Biotech Products - EU

EU Definition of Biological Medicine

According to Part I of Annex I of Directive 2001/83/EC (as amended by directive 2003/63/EC),

a biological medicinal product is a product, the active substance of which is a biological substance.

A biological substance is a substance that is produced by or extracted from a biological source

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