On September 14, the National Medical Products Administration (NMPA) made headlines with an important announcement regarding propolis oral films. This update is set to improve public access to medications and encourage responsible drug use.
In a recent evaluation, the NMPA has reclassified propolis oral films from a Class A over-the-counter (OTC) drug to a Class B OTC drug. Alongside this classification change, revisions have been made to the accompanying instructions for these OTC drugs.
The NMPA has called on relevant drug marketing authorization holders to submit the updated instructions to provincial drug regulatory authorities by June 11, 2025. This requirement is in line with the Drug Registration Management Measures (Order No. 27 of the State Administration for Market Regulation) and other applicable regulations. Furthermore, these holders are expected to promptly inform relevant medical institutions and drug distribution companies about the changes.
It’s important to note that any additional content included in the OTC drug instructions must still comply with the original approval documentation. Labels affected by these updates will need to be revised accordingly. Once a supplemental application is filed, any drugs produced must not utilize the previous instructions.
