Adverse Drug Reaction
The Tanzania Medicines and Medical Devices Authority participate in various local and regional initiatives on harmonization of regulatory processes including processes for clinical trials control. The work to develop harmonized tools for regulatory oversight among the East African Community (EAC) Partner States is underway. For more information about joint collaborative efforts on regulatory processes for medical products please click here
TMDA is a member of the African Vaccine Regulatory Forum (AVAREF) which was created by the World Health Organization to develop capacity on regulatory oversight of interventional clinical trials being conducted in Africa. For more information about AVAREF please click here
3) Forms for Reporting Adverse Events
- Form for reporting ADR by health care providers
- Form for reporting ADR by consumers/patients
- Form for reporting Poor Product Quality
- Form for reporting AE related to Medical Devices and Diagnostics
4) How to Report Adverse Events and Incidents related to Medicines and Medical Devices
For paper based reporting of Adverse Events please click here
For online/ electronic reporting of Adverse Event follow the link
All drugs even if taken appropriately may present adverse drug reactions ranging from mild to severe form and fatal reactions. Some of the reactions are predictable and therefore can be avoided but some of them are not predicted. The feedback of how the registered medicines and licensed vaccines are doing in the market is important for the TMDA to continue make informed decision every time. Forms for reporting of all suspected Adverse Drug Reactions (ADRs) and Adverse Events Following Immunizations (AEFIs) have been distributed to health facilities. The yellow forms were designed to collect safety reports of medicines and vaccines by health care personnel while the green forms are for consumers reporting of suspected ADRs and AEFIs.
The online ADR reporting app which uses android technology can also be accessed from the Google play store.
A simple short text message to report any suspected AE/ADRs can also be send by just following the instructions after dialling *152*00#
Why reporting of Adverse Drug Reactions and Adverse Events Following Immunization
The system for reporting of Adverse Drug Reactions and Adverse Events Following Immunization was established in order to;
- Detect the ADR/ AEFI as early as possible, especially serious, unknown and infrequent
- Establish the frequency and incidences for both the well-recognized and newly discovered events.
- Identify all factors that may induce and /or influence the development of Adverse Events
What to report
All suspected adverse events should be reported whether known or unknown, serious or not, including minor ones. Reports on the new drugs are of great interest because they make easier to monitor the performance of these drugs in the country for any suspected adverse drug reactions.
Who should report
All health care providers including specialists, doctors, dentists, pharmacists and nurses can report ADRs and AEFIs. All affected consumers are encouraged to report ADRs directly to their healthcare professionals and zonal Drug Information centers. The reports should be sent to the Director General, TMDA, P.O. Box 1253, Dodoma, fax +255 22 2450793 email adr@tmda.go.tz .
How to access the reporting forms
Adverse drug reaction forms may be obtained from TMDA headquarters, Zonal Drug Information Centres, offices of Regional Medical Officers or Regional Pharmacists and healthcare facilities.
How to report
Suspected adverse reactions for drugs marketed in Tanzania should be reported using a standardized form which is postage pre-paid and self-adhesive. It contains the following elements
- Detect the ADR/ AEFI as early as possible, especially serious, unknown and infrequent
- Establish the frequency and incidences for both the well-recognized and newly discovered events.
- Identify all factors that may induce and /or influence the development of Adverse Events
- Patient information including Patient identifier, Age/Date of birth, Sex, Weight and relevant medical history.
- Description of the adverse reaction including date of onset.
- Suspected drug(s): name (including brand name, if known), dosage, route, start and stop dates, and reasons for use
- Treatment given for the reaction(s).
- Other relevant history, including pre-existing medical conditions
- Outcome of reactions
- Name, date, signature and address of the reporter.
All sections of the form should be dully filled prior submission. A separated form should be used for each patient.