Tanzanian Food and Drugs Authority
Since my last blog, I have been thrust into the world of the Tanzanian regulations. Meetings with the Tanzanian FDA (TFDA), meeting with local stakeholders of my project work, and coordinating final goals with the home office in Amsterdam have been priority. My project, you say? It is easily explained now that I have completed Phase I fact finding from my objectives. Simply explained, I am looking at increasing the capacity of PharmAccess to use quality systems, quality assurance objectives and access to credit for small drug sellers in Tanzania. This is actually quite a bit of work, but with a good background now, I feel confident that there will be some good success out of the collaboration of everyone involved.
It is interesting to look at regulations from a different perspective (i.e., looking at how they affect a patient versus how they affect an industry). It is also interesting to have interactions with high FDA officials here in Dar es Salaam. Considering how elaborate the structural capacity of the U.S. FDA these types of officials would only be met with from our highest of corporate representatives. After the first meeting with the TFDA, it was clear that many things are still done here with a “who you know” type of mentality. . Everyone is polite, and there is a certain amount of respect that is just assumed and followed. People are immediately put at ease because of the friendly feelings that are invoked when you are speaking. It is an interesting way to do business in an area that you would expect to be highly regulated (which they are working on and making great progress), but it is also a way to remember how far there is yet to go. The TFDA is a newly created entity (within the last 10-15 years), and they have structured their systems similarly to the U.S. Some of that, I am told, was because they had an ex-FDA director from the U.S. helping them build their foundation. The biggest struggle they will have in the coming years is financing as they struggle to regulate a system that has never been truly regulated. When one thinks about the process and work in a U.S. FDA audit, it invokes a certain amount of “panic” in the highly regulated U.S. industry. For Tanzanians, there are very few local manufacturers of medicines. The majority of their capacity comes internationally. The ability of the TFDA to audit suppliers outside of Tanzania becomes costly, and they prefer to deal with things locally. Unfortunately, the manufacturers of local pharmaceuticals get their visits from their regulating authority on a regular basis. Can you imagine the FDA taking a parking lot spot in your manufacturing site only because they are the only ones that can train new employees? The few manufacturers that have remained have committed to upgrades, compliance issues, and consistent visits, while other manufacturers that existed pre-TFDA exited the country as soon as the regulations went into effect. Interesting. Controlling the flow of sub-standard and counterfeit drugs into the country is a big concern. Part of my project is to help PharmAccess, as much as feasible, to consider a drug quality assurance system to assist the community in these circumstances. While the goal is not to control what is circulating throughout the market; it is giving assurances to the patients being served the reassurance they are receiving quality, reliable medication. I am proud to be a part of this assignment that can potentially help so many. In the coming weeks I will travel to Moshi/Arusha in north Tanzania to meet with facilities that have already made changes to help preserve the integrity of their institutions. People want to look a person in the eye and communicate with a sit down meeting. Although this way of business is not used much anymore in Western society, I do prefer the hand shake, the ability to look someone in the eye, and the sincerity of one’s intentions in their voice. It is very nice to be able to have human contact instead of a computer connection, a phone connection, or a fax. Maybe in some ways, we have much to learn from our Tanzanian friends?View all posts by Tracy.Sienko »