The Tanzania Medicine and Medical Devices Authority (TMDA) oversees the safe, quality and effective regulation of medicines, medical devices and diagnostics in Tanzania. The Authority is under the Ministry of Health, Community Development, Gender, Elderly and Children. The TMDA’s primary responsibility is stated in the Tanzania Health Policy (2007), and its authorisation is instructed in the Tanzania, Food, Drugs and Cosmetics Act Cap 219 (2003).

The Guidelines on Submission of Documentation For Registration Of Human Pharmaceutical Products first published in January 2015 outlines the procedures and requirements for the registration of pharmaceutical products (Randeria et al., 2018). According to the specified guidelines, with the Common Technical Document (CTD) format, each application is a collection of documents, grouped into 5 modules. These include:
•      Administrative and prescribing information requirements
•      Quality Requirements
•      Clinical data Requirements
•      Non-Clinical Data Requirements
The applicant saves the CTD dossier on a CD-ROM for submission to the Director-General. This submission is accompanied by the application fees, samples and other essentials. The Director-General would notify the applicant of receipt.
The Authority may charge the applicant of any costs that that is incurred to carry out Good Manufacturing Practices inspection or laboratory investigations before the registration of any drug or product. Once the drug complies with its intended purpose and meets the set requirements, the Authority will consider approving for the registration of the drug. The Director-General enters the details of the drug into the register, allocates a registration number and issues a certificate of registration.
Tanzania is in the pilot phase of rolling out its Online Medicine Registration platform as part of its Integrated Regulatory Information Management System. This portal is available on the TMDA website.

Under the Good Manufacturing Practices enforcement regulations, there are 4 types of inspection. These include:
•      Special inspection
The routine inspection is conducted any time after a product has been registered but before the expiry of the product. The concise inspection is conducted where an applicant product has become eligible for being considered for market authorization. Follow-up inspection may be conducted with the view to verify the observations of any GMP inspection conducted.
Special inspection is conducted when there are complaints of a specific product that has defects when there is a product recall due to related events such as adverse drug reactions or where there is a need to investigate specific operations of the manufacturing processes. An applicant applies to the Director-General by submitting a filled application form, the inspection fee and the latest version of the site master file.
The Authority assesses the application by desk review or uses any other inspection report from a relevant regulatory body. This is to satisfy that the application has complied with the conditions for good manufacturing practice. A criterion would be used to evaluate the documents for desk review. Once the application meets the requirements, the Authority shall issue a certificate of Good Manufacturing Practice. This certificate is valid for three years. An online GMP application system has been developed by the TMDA, how the application is in its pilot stage and has not been fully rolled out.

There is no information available on a laboratory information management system. However, TMDA has a Quality Laboratory that was established to analyze food, medicines, cosmetics, diagnostics and medical devices. According to the website, to ensure customers of quality generated results, the medicines and cosmetics and analysis section of the laboratory has been prequalified by the World Health Organization since 2011, while the Food and Microbiology section had been accredited per ISO/IEC 17025:2005 standard in 2012.

The TMDA coordinates activities relating to monitoring and reporting of existing and new adverse events. These primary activities include detection, assessment, understanding and the prevention of ADRs (Tanzania Medicine and Medical Devices Authority, 2013). The National Medicines Policy indicates the need for raising awareness on reporting Adverse Drug reactions at all level.
Tanzania uses two different systems for monitoring adverse events or reactions. These include the spontaneous reporting system and the active surveillance system. There is a national pharmacovigilance centre within the TMDA headquarters building in Dar es Salaam. This national centre reviews ADR forms and collects reports of suspected adverse reactions to other medicines and products on the market.
Tanzania also has 8 zonal pharmacovigilance centres that work together with the zonal TMDA offices. They coordinate pharmacovigilance activities in various zones. They also coordinate with the various council and regions in the zones to receive information, respond to queries and provide information relating to pharmacovigilance.
Details of adverse reaction reports are fed into the Vigiflow data management tool, where accessible or the reports are sent to TMDA for further action. Tanzania also has an Adverse Reaction Reporting Tool. This system coordinates the reporting of reactions caused by medicines, cosmetics, medical devices and vaccines. There are various forms available to the reporter based on the chosen category (Drug/ Medical device / Cosmetics). There is also a mobile application available in Google Play Store to report adverse drug reactions. Individuals who do not use a smartphone or do not have Google Play Store have a USSD code available (*152*00#) to report adverse reactions. The reports can also be sent to the Director General’s address, via fax or email.

According to the Tanzania Food, Drugs and Cosmetics Regulations for Clinical Trials Control, applicants for the conduct of clinical trials shall be required to register the clinical trial with the Authority. The applicant will provide the national registry with details regarding the research and its intended purpose. The applicant shall apply to the custodian of the national registry to include in the national registry.
Details of the clinical trial submitted are entered in the registry no later than 30 days of its submission (Tanzania Medicine and Medical Devices Authority, 2017). The Director-General ensures that the national registry includes the status and results of the clinical trial. In any clinical trial, the Authority approves the principal investigator if he or she meets the minimum qualifications and experience.
The investigator ensures that the clinical trial is conducted following the Good Clinical Practices requirements. The principal investigator shall be responsible for the conduct of the clinical trial at the investigator site. The sponsor shall implement and maintain quality assurance and quality control systems to ensure that trials are conducted, and data are generated, documented, recorded and reported in compliance with the protocol, good clinical practice and these Regulations.
Monitors are appointed and will be trained appropriately on the clinical knowledge needed to monitor the trial adequately. The Authority ensures that the subjects of the trial are satisfactorily insured against possible injuries that might arise during the conduct of a clinical trial per the laws of Tanzania (Tanzania Medicine and Medical Devices Authority, 2017).
The principal investigator or sponsor submits written clinical trial progress reports annually, or more frequently, as may be required by the Authority. After the completion of the clinical trial, the principal investigator or sponsor shall submit a final study report to the Authority per the format provided by the Authority. Tanzania has a clinical trial registry (TzCR) web platform. However, it is also piloting the Clinical Trial aspect of its integrated Regulatory Information Management System (iRIMS). These platforms can be accessed through the TMDA website.

TMDA has post-marketing surveillance regulations in place to monitor the quality, safety and efficacy of a pharmaceutical drug or device on the market after it has been released on the market. TMDA performs post-market surveillance on pharmaceutical products and medical devices (Tanzania Medicine and Medical Devices Authority, 2018b).
Manufacturers can be requested by the Authority to conduct Post-Most Surveillance. An instance could be when there are less common safety and effectiveness issues for which pre-market testing provided limited information. Post-market surveillance may also be needed in assessing the effectiveness of the device or drug in detecting or treating a disease or condition rather than using a surrogate.
Data from the post-market surveillance would include rates of malfunction or the failure of a device intended for long-term use or incidents of latent sequel resulting from the use of the device. When the Authority requests for post-market surveillance, a post-market surveillance plan must be submitted within 30 days from the day the post-market surveillance order in a letter was given.
An interim PMS study status report is submitted every six months for the first two years of the study and annually after that, from the negotiated starting date (Tanzania Medicine and Medical Devices Authority, 2018b). A final post-market surveillance study report should be written and submitted no later than three months after the completion of the study. It is advised for the reporting of the interim post surveillance status report to continue until the manufacturers submits the Final Post Market Surveillance Study Report. There is limited information on the technologies used for post market surveillance.

The TMDA issues permits for imports and exports. The Tanzania Food, Drugs and Cosmetics (Registration of Premises, Importation and Exportation of Pharmaceutical Products and Raw Materials) Regulations, 2015, serves as the guideline for the import and export of pharmaceutical products in Tanzania.
Per the regulations, no person is allowed to import or export pharmaceutical products or raw materials unless he or she has a pharmacist registered by the Pharmacy Council, has licensed premises registered with the Authority and holds a business permit (Tanzania Medicine and Medical Devices Authority, 2015).
To apply for an import or export permit, the applicant must fill the required form which is available on the website (Form TFDA IV & V). The form should be submitted to the Authority for review and consideration. The applicant would have to pay the prescribed fee as stated in the fee and charges regulations document.
The Authority will review the application to determine if it meets the set standards and conditions. When the application meets the stated conditions in the regulations and the proof of payment of the application has been submitted, the Authority would then issue an import or export permit. The validity of the import permit is six months while that of the export permit is three months.
The permit can only be used for a single consignment, and it is not transferable to another person. Tanzania has an import or export application system for applicants. Applicants can submit their applications through the portal and would receive feedback. The portal is accessible through the TMDA website.

TMDA does not include licensing for professionals but premises only. Regulations indicate that the Authority ensures that there is a licensed professional such as a licensed pharmacist from the pharmacy council is present to discharge the needed duties at the premises. TMDA has an online premises registration application portal available through the TMDA website. The portal is being rolled out and is in its pilot phase. The portal is an aspect of the Integrated Regulatory Information Management System (I-RIMS) being developed.
To apply for a premises permit issued by the Authority, the candidate must write an application following the set requirements stated by the Authority and pay the necessary application fee (Tanzania Medicine and Medical Devices Authority, 2015). The set guidelines can be found on the TMDA website. Upon submission, the Authority will review to determine if the application meets the set guidelines and would consider issuing premises permit. Permits for premises is subject to renew based on the terms stated on the application form.

The TMDA considers tracking and traceability as a significant aspect of risk management. Data acquired through risk management would help determine which devices or products would have to be traced.
TMDA may require that manufacturers track specific devices when directed. Tracking helps to facilitate notification and recall in the event a device presents a severe risk to health that requires prompt attention (Tanzania Medicine and Medical Devices Authority, 2018b). This enables TMDA to require the manufacturer to identify the product distribution information and remove the product from the market.
Post-approval studies are used to assess device or product safety, effectiveness, or reliability in the real-world setting, including long-term effects. It also helps to assess the learning curve, effectiveness of training programs and how well the product performs in certain groups of patients. When TFDA determines that a device should no longer be tracked, it will notify the manufacturer by direct communication.
The manufacturer will be required to notify health professionals and patients in the event of an unreasonable risk of substantial harm associated with a device or product. Manufacturers must make sure that the tracking program works. Manufacturers must perform audits at 6-month intervals for the first 3 years after receiving tracking orders, and then annually after 3 years according to the set regulations by the Authority.
Audits should verify that the tracking method work and that the information collected is accurate so that, in the event of a recall, the right persons are notified in a timely fashion. However, there is limited information on the technologies used throughout the track and trace period (Tanzania Medicine and Medical Devices Authority, 2018b).

The National Guidelines for monitoring medicines safety indicates that the TDMA should have a monitoring and evaluation system in place to monitor and evaluate the performance of the pharmacovigilance system. The monitoring and evaluation system would evaluate timelines and accuracy of reports, case management, timeliness of responses to issues raised and appropriateness of actions taken to avoid system error.
Indicators to be used when evaluating the pharmacovigilance system include reporting quality, reporting rate, promptness of reporting, among others (Tanzania Medicine and Medical Devices Authority, 2018b). There is a planning, monitoring and evaluation department in place; however, information on the processes carried out by the department is limited.

The Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 contains all the details regarding the fees charged by the TMDA regarding all their services. In December 2018, a news article on the TMDA website indicated that payments for all TMDA services were to be done through the Government Electronic Payment Gateway (GePG) (Tanzania Medicine and Medical Devices Authority, 2018a). The payments will be made through a payment control number available on pro forma invoices. Contact numbers were given for customers who wanted more details or needed clarification. There is limited information on other aspects of Finance with regards to the TMDA.