Chinese FDA Released Guidelines for Rx-OTC Switch

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The State Food and Drug Administration (“SFDA”) recently announced a set of technical guidelines for switching prescription drugs to over-the-counter drugs (“Rx-OTC Switch Guidelines”). The Rx-OTC Switch Guidelines include the Tentative Evaluation Guidelines for Rx-OTC Switch, the Principles for Defining the Indications of OTC Drugs, the Evaluation Guidelines for Traditional Chinese Medicines (“TCM”) with Toxic Ingredients to be switched to OTC Drugs, the Principles for Defining Class B OTC Drugs, the Indications of OTC Drugs (TCM Section), and the Indications of OTC Drugs (Chemical Drugs Section).

A prescription drug is qualified for OTC evaluation if it meets the following basic requirements...

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