ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

15^th June, 2023

NEW GUIDELINES FOR GOOD MANUFACTURING PRACTICES (GMP) INSPECTION OF HUMAN MEDICINAL PRODUCTS MANUFACTURING FACILITIES, 2023

1. The Tanzania Medicines and Medical Devices Authority (TMDA) wishes to inform its esteemed Stakeholders that, the new GMP Guidelines for inspection of Human Medicinal Products Manufacturing Facilities have been developed.
2. The development of these new Guidelines is attributed to the fact that the Compendium of Good Manufacturing Practices (GMP) Technical Documents for Harmonization of Medicines Regulation in The East African Community, 2014 is outdated and therefore no longer in line with the current GMP standards. The new GMP Guidelines have been crafted based on the current World Health Organization Technical Report Series (WHO TRS).
3. We wish to inform our Stakeholders that the new Guidelines came into force on 1st April 2023. The Guidelines can be accessed through the TMDA website: www.tmda.go.tz.
4. For further clarification on this notice, please do not hesitate to contact the Authority through e-mails: at info@tmda.go.tz, or by phone and address below.
5. We thank you for your continued cooperation.