OTC~ How to declare drugs ~! !

The above three kinds of new Chinese medicine (new prescription preparation), if the prescription contains ingredients not included in the Pharmacopoeia, should be declared as new drugs first, and after preclinical research (such as pharmacodynamics, toxicology, pharmacy, etc.). ), it shall be reported to the provincial food and drug administration for approval and inspection. After passing and meeting the requirements, report to the National Bureau for approval to arrange the second phase of clinical research. Upon completion, the National Bureau will issue a new drug certificate and production batch number to start trial production. Please consult the US Food and Drug Administration for details.