Company A, a domestic botulinum toxin developer, recently received approval from the U.S. ...

South Korean botulinum toxin makers lose 90-100 billion won annually due to mandatory government pre-export approvals for a 'core national technology' designation imposed in 2010-2016, despite the toxin being public knowledge since the 1940s and already regulated through six ministries and seven laws. One company took 14 years to reach FDA approval partly due to these delays, whilst a competitor missed market timing and had to launch 45% below competitors' prices.

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