www.fdanews.com/articles/115469-tanzania-updates-its-guidelines-on-drug-registration-variations
Tanzania Updates Its Guidelines on Drug Registration, Variations
March 17, 2009
The Tanzania Food and Drugs Authority has revised its guidelines for applications to register new drugs and formulations of registered drugs. The new guidelines detail requirements for active pharmaceutical ingredients and finished pharmaceutical products. The variations guidelines apply to APIs and excipients manufactured by chemical synthesis or semisynthetic processes and FPPs containing such APIs and excipients.
International Pharmaceutical Regulatory Monitor
International Pharmaceutical Regulatory Monitor