How legal is bio-engineered artemisinin

The FDA-CDER regulation from 2004 on Botanical Drug Products states : the term botanicals includes plant, materials, algae, macroscopic fungi, and combinations thereof.

It does not include fermentation products (i.e. products produced by fermentation of yeast, bacteria and other microscopic organisms… and products produced by fermentation of plant cells), even if such products are previously approved for drug use or accepted for food use in the United States.

It is also the regulation followed by EFSA (European Food Safety Agency) and EMA (European Medicin Agency).

This would mean that artemisinin produced by the bio-engineered synthesis in California, Berlin oor South Africa may not be considered for antimalarial drugs, unless it has previously been approved by these authorities.

Who knows more?

lutgenp@gms.lu


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