ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

02^nd October, 2023

DRAFT GUIDANCE ON THE QUALITY AND CLINICAL REQUIREMENTS FOR INHALATION AND NASAL MEDICINAL PRODUCTS

1. The Tanzania Medicines and Medical Devices Authority (TMDA) would like to inform our esteemed Stakeholders that, we have recently developed Guidance on The Quality and Clinical Data Requirements for Inhalation and Nasal Products.
2. The document aims to guide applicants on the quality and clinical data requirements that should be submitted to support marketing authorization of nasal spray and inhalation medicinal products.
3. In view of this TMDA is inviting comments on this draft guidance which will help to finalize this document. The comments should be compiled in the format document provided. (Click here to access the template).
4. Please send electronically your comments to the Authority through e-mail medicines@tmda.go.tz, and copied to felchism.apolinary@tmda.go.tz.
5. The Guidelines will be available for comments until 20th October, 2023.
6. Please Click here to access the draft Guidelines.
7. We thank you for your continued cooperation.