In the ever-evolving landscape of pharmaceuticals, compliance with regulatory authorities is key to ensuring the safety and efficacy of products entering the market. Tanzania Medicines and Medical Devices Authority (TMDA), an Executive Agency under the Ministry of Health, Community Development, Gender, Elderly, and Children (MOHCDGE), plays a pivotal role in regulating the quality, safety, and effectiveness of medicines, medical devices, and diagnostics in Tanzania.
TMDA Regulatory Framework
1. Company Registration
Companies must undergo registration with TMDA as part of the regulatory process.
2. GMP Inspection
TMDA conducts Good Manufacturing Practice (GMP) inspections for site registration to ensure that manufacturers adhere to quality standards. Inspection Fee will charge per line.
3. CTD Dossier Submission
The Common Technical Document (CTD) format is required for dossier submission, ensuring a standardized and comprehensive approach.
4. Registration Assessment
- Registration assessment may require 18-24 months. Delay may occur on incomplete documentation.
- Fast Track Registration Fee: Double the standard fee for expedited processing.
5. Import Samples
- Importers are required to submit samples with a shelf life of 2 years for medicines and 3 or 4 years for medical devices.
6. Duration of TMDA Dossier Evaluation
- The evaluation period for the TMDA dossier typically spans 3-4 months.
- Renewal of CTD Dossier: To be initiated 3 months before expiry, including the submission of samples with a shelf life of 1 year.
- Renewal Fee: $2,000 USD
7. Variations
- Major Variation Fee: $1,000 USD
- Minor Variation Fee: $300 USD
- Duplicate Certificate Fee: $100 USD
8. Retention Fee
Retention fee will have to pay every year to maintain the registration.
9. Price Control
- TMDA implements price control measures to ensure affordability and accessibility of pharmaceuticals and medical devices.
Following are the regulatory scenario in Tanzania:
(a) A local Distributor/Legal entity is mandatory to hold the drug/medical device/cosmetics product registration in Tanzania.
(b) Govt. fees per medicinal product = 2000 USD
(c) TMDA regulatory team will physically inspect the plant of the manufacturing country. Inspection fees for GMP inspection is USD 6000/plant. and Inspector visiting allowance will be charged.
(d) Registration certificate is valid for 5 years. GMP Certificate is valid for 3 years.
(e) Clinical trial is not mandatory.
(f) Total timeline to get the registration certificate, 18 – 24 months.
(g) Soft copy CTD is required for Online submission.
For dossiers preparation, regulatory intelligence reports and customized questions you may contact.
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