NMPA Announces OTC Switch for Naftifine Ketoconazole Cream and Metronidazole Vaginal Gel

Pharmaceutical products

On July 5, 2024, the National Medical Products Administration (NMPA) announced the reclassification of Naftifine Ketoconazole Cream (萘替芬酮康唑乳膏) and Metronidazole Vaginal Gel (甲硝唑阴道凝胶) from prescription to over-the-counter (OTC) status. This reclassification, outlined in Announcement No. 87 of 2024, follows the guidelines in the “Administrative Measures for the Classification of Prescription and Non-prescription Drugs (Draft)” (Order No. 10 of the original State Drug Administration).

This decision was made after an evaluation by the NMPA, aiming to increase accessibility and sales of these medications, which are used in dermatological and gynecological therapeutic areas.

Key Points

  • Reclassification: Naftifine Ketoconazole Cream and Metronidazole Vaginal Gel have been officially reclassified from prescription drugs to OTC drugs.
  • Submission Deadline: Marketing authorization holders must submit updated labels to provincial drug regulatory departments by April 2, 2025, in accordance with the “Drug Registration Management Measures” and other relevant regulations.
  • Communication: Revised instructions must be promptly communicated to relevant medical institutions and pharmaceutical enterprises.
  • Label Compliance: Any additional content in the OTC instructions beyond the NMPA template must adhere to the original approved certification documents, and drug labels must be revised accordingly.
  • Production Compliance: From the date of submission, the production of these drugs must cease using the original labels.
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