Post Marketing Surveillance of Medicines
Post Marketing Surveillance (PMS) refers to systems for monitoring quality, safety and efficacy of medicines after they have been registered and released on the market. It is the mechanism in place to assess the medicines taken by patients under a wide range of environment over an extended period of time. PMS is considered as an additional measure of quality assurance which aims at ensuring that quality specifications of the registered medicines are maintained throughout their approved shelf life. The quality of the medicine is very crucial since it has an implication on the safety and efficacy of the medicines. Henceforth the methodologies used for PMS in Tanzania includes Drug Quality Assurance Program which focuses on conducting primary screening of medicines and the Structured PMS Programs which focuses on sampling and testing based on risks.
In this regard, TMDA has been implementing PMS activities using three-year PMS programmes from the year 2007 where medicines are collected from the market and analyzed for the purpose of ensuring that quality. Since its inception, four (4) Structured PMS programs have been conducted 2007 to 2009, 2011 to 2013, 2014 to 2017 and 2017 to 2020.
Structured PMS Programme is done through different steps starting with preparation of sampling plan and budget, training of sample collectors, conducting sampling activities, conducting product information review, laboratory screening and confirmatory testing of collected samples, evaluation of the results and report writing and regulatory actions (withdraw of registration of medicines, recall, and issuance of public alert).