Module 9 2024

03/09/2024

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

AND that needs for its characterisation and the determination of its quality a combination of physico chemical-biological testing together with the production process and its control.

The Organisation for Professionals in Regulatory Affairs

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Implication of these different definitions

Peptides >40 amino acids are now regulated as a biological in both the USA and EU.

e.g. Insulin (51 amino acids) is now regulated under the PHS act meaning it also falls under biosimilar pathways

However,

Low molecular weight heparin, FD&C act in USA, biological in the EU

And for Peptide Based Cancer Vaccines - in the US theses are regulated as biologicals regardless of size but in the EU, if synthetically manufactured they are small molecules

The Organisation for Professionals in Regulatory Affairs

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