Drug Regulatory Procedures in Tanzania

Tanzania, officially the United Republic of Tanzania is a country in East Africa in the African Great Lakes region. Drugs in Tanzania are controlled by the Tanzania Medicines and Medical Devices Authority (TMDA). This article shows various applications and other requirements for drug approval in Tanzania. TMDA is a regulatory body responsible for controlling the quality, safety, and effectiveness of food, drugs, herbal drugs, cosmetics, and medical devices.

Drug Registration Application

An application consists of documentation and electronic forms, samples, and fees. All application needs to be submitted online at TMDA official website.

Applications are classified into 4 categories as follows

1. New Application
2. Application for Variation of a registered medicinal product
3. Application for importation and exportation of pharmaceutical products
4. Application for safe disposal of unfit medicines and cosmetics products

1. New Application

This is given for registration of any new product in Tanzania.

Registration requirements:

a. Pre-Registration Requirements

• Identification of a local person in Tanzania or a company incorporated in Tanzania and authorized by TMDA to deal in medicinal products
• Power of attorney that complies with Tanzanian laws.
• GMP (Good Manufacturing Practices) inspection by TMDA

b. Registration requirements

Section 1: General Information

• Application Form

1. Quality Information Summary
2. Bioequivalence Information Summary

• Table of contents
• Certificate of Pharmaceutical Product
• Site Master File

Section 2: Summary of Product Characteristics

Section 3: Active Pharmaceutical Ingredient (API)

This section also includes documents like

• CEP (Certificate of Suitability to the monographs of the European Pharmacopoeia) + sections not covered in CEP or
• DMF (Drug Master File); or
• Declaration by the API manufacturer

Section 4: Finished Pharmaceutical Product(s) (FPP)

Section 5: Therapeutic equivalence

Section 6: Pharmacology, toxicology and efficacy of new products

Section 7: Fixed dose combination medicinal products

Evaluation Process:

• Evaluation is done on a first-in-first-out (FIFO) basis unless the product meets the fast-track criteria. Assessment involves evaluators from within or outside TMDA. The report produced by the evaluator is reviewed by 2nd senior evaluator/s who does the quality assurance of the report & finalizes the report & recommendations.
• A summary of recommendations of evaluation, lab analysis & GMP status reports is presented before the Human Medicines Registration Technical Committee (HMRTC) for consideration & making final recommendations for granting or rejecting registration of the product. Process of evaluation has been summarized in Figure 1.

Timelines

a. Evaluation of New Applications: 

Complete applications are evaluated within 180 working days of receiving the application including evaluation of documentation and consideration by a technical committee.

b. Fast-Track Evaluation: 

An application may be fast tracked & be evaluated within six months of its submission, if the applicant has requested & paid twice the prescribed evaluation fees and the product is lifesaving, or the product is indicated for diseases which at the time of application have no registered alternative medicine or evidence has been submitted in a motivation letter accompanying the application to show that the product has significant advantages in terms of safety and efficacy over existing products indicated for treatment or prevention of life-threatening diseases.

Validity of Registration

The registration of a human medicinal product is valid for five (5) years unless earlier suspended or revoked by TMDA or withdrawn by the applicant.

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2. Application for variation of a registered medicinal product

Any changes to registered products (variations) may involve administrative and / or more substantial changes and are subject to approval by TMDA. Procedures for the implementation of the different types of variations need to be set out in order to facilitate the task of both Marketing Authorization Holders and TMDA and to guarantee that variations to the medicinal product do not give rise to public health concerns.

3. Application for Importation and Exportation of Pharmaceutical Products

Importation of pharmaceutical products and raw materials Categories of importers of pharmaceutical products and raw materials

Importers of pharmaceuticals shall fall under the following categories:

1. Government and Non-governmental institutions
2. Pharmaceutical wholesalers
3. Pharmaceutical manufacturers
4. Clinical trial sponsors and principal investigators
5. Recipients of donations

However, the following in special circumstances can be authorized

• Persons authorized to import pharmaceuticals for personal use
• Hospitals authorized to import pharmaceuticals for hospital use

Requirements for importers

• All pharmaceutical products to be imported must be registered by TMDA unless given special approval by the Authority.
• All importation of pharmaceutical products must be done by importers whose premises are fully registered by TMDA or relevant Government institutions.
• All importers must import pharmaceutical products through the authorized POE (Port of Entry).
• In the case of donations, an importer must have a donation certificate and adhere to the Guidelines for Donations. The donated pharmaceutical products must be fit for human consumption, safe and of good quality, and not prohibited in the country of origin.
• No person shall import any pharmaceutical product with a shelf life of more than 24 months whose remaining shelf life is less than 60% and a drug with a shelf life of less or equal to 24 months whose remaining shelf life is less than 80%.
• All imported pharmaceutical products should adhere to the following labeling requirements:

1. The information printed on labels must be indelible, engraved or embossed on a primary and secondary container.
2. The immediate outer packaging of the pharmaceutical products should be clearly labeled in English or Swahili language or both
3. The trade or brand name where appropriate shall be stated
4. The International Non-proprietary Name (INN, Generic name) shall be clearly stated
5. Quantities of active ingredients in the given formulation / API
6. Date of manufacture and expiry
7. Batch or Lot number
8. Storage conditions
9. Name and address of the manufacturer
10. Registration number of the product issued by TMDA in both the outer and inner package of the product(s) where applicable
11. Enclosed and accompanying literature must be in English or Swahili language.
12. API specification (BP, USP, etc)

Exportation of Pharmaceutical Products and Raw Materials

A. Exporters of pharmaceutical products

Exporters of pharmaceuticals fall under the following categories

• Registered local pharmaceutical manufacturers
• Registered wholesalers
• Clinical trial sponsors and investigators
• Person authorized by TMDA

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B. Requirements for exporters

• No person shall export pharmaceutical products out of the country without having a valid export permit issued by the Authority
• All pharmaceutical products to be exported must come from a registered manufacturer or wholesale pharmacy in Tanzania Mainland
• All exporters must export pharmaceutical products through the authorized PoE

4. Application for safe disposal of unfit medicines and cosmetics products

• For quite a long time, the disposal of unfit medicines and cosmetic products in Tanzania was not been done systematically and professionally due to lack of appropriate guidance which resulted to the accumulation of unfit medicines and cosmetic products in drug outlets in the country. 
• The accumulation of these products has been mainly contributed by lack of adequate knowledge on procedures for safe disposal of unfit medicines and cosmetics products among the dealers.
• In order to protect the entire Tanzanian population, medicines and cosmetics manufacturers, dealers, private health facilities and institutions, Local Authorities, Non-Governmental Organizations (NGOs), drug inspectors and the general public are required to adhere to set procedures as stipulated in these guidelines.
• TMDA has developed the guidelines to provide guidance to medicines and cosmetics dealers on how to dispose off medicines and cosmetic products safely. The guidelines have been developed in line with the current development in science and technology of medicines and cosmetics formulations based on the World Health Organization (WHO) Guidelines for safe disposal of unwanted pharmaceuticals in and after emergencies.

Procedures for application to dispose off unfit medicines and cosmetic products

• Any person who intends to dispose off unfit medicines or cosmetic products shall adhere to the following procedures:
• Request in writing to the Director General of TMDA by using the application form which is available at TMDA headquarters offices, TMDA zone offices, Regional and District Medical officer’s offices and TMDA website: www.tmda.go.tz.
• A request shall be accompanied with a list of products to be disposed of and should state clearly trade name, generic name and strength (where applicable), dosage form, pack size, quantity, manufacturer, batch number and market value of product.
• Once the request has been received by TMDA, the Authority shall acknowledge and inform the applicant through a letter to contact Directorate of Medicines and Cosmetics to arrange or TMDA zone offices for verification of the product. In case of regions where there are no TMDA zone offices, applicant shall be informed to contact the Regional or District Medical officer’s offices for the same.
• TMDA-HQ or TMDA zone office / Regional / District Medical officer’s offices shall send inspectors to the premises to verify and authenticate the information submitted.

Various disposal methods for different categories have been summarized in Table 1.

Sr. No.	Category	Disposal Methods
1	Solids, semi-solids, and powders	Landfill, incineration, waste immobilization
2	Liquids	Sewer, high-temperature incineration, treated waste
3	Antineoplastics	Treated waste, landfill, high-temperature incineration, return to manufacturer
4	Controlled drugs	Treated waste, landfill, high-temperature incineration
5	Aerosols and inhalers	Landfill without waste inertization
6	Disinfectants	Sewer or fast-flowing watercourse
7	PVC plastics, glass (ampoules, bottles, vials)	Landfill, recycling
8	Paper, cardboard	Recycle, burn, landfill

Destruction of Unfit Medicines and Cosmetic Products

Destruction of unfit medicines and cosmetic products shall involve the following procedures:

• A Drug Inspector, Health Officer, Environmental Officer and Policeman shall supervise the transport of consignment from the owner’s premises to the disposal site for destruction exercise.
• The destruction exercise shall be supervised by Health Officer, Environmental Officer, Policeman and Drug Inspector.
• Unfit medicines and cosmetic products shall be transported in a closed motor vehicle to avoid pilferage.
• Supervisors shall wear protective gears such as overalls, gloves, masks, caps and boots during the exercise.
• Upon completion of the exercise, a Drug Disposal Form shall be duly filled in and signed by the supervisors and owner/owner’s representative.
• Drug Disposal Form shall be sent to TMDA headquarter offices.
• Once TMDA has received the form, a certificate of destruction of unfit medicines and cosmetic products shall be prepared and sent to the consignee.
• Particular care shall be taken while handling anti-cancer drugs, narcotic drugs and Penicillins to avoid associated hazards.

Fees

As per the TMDA regulations, an applicant has to pay fees depending on the type of certification applied for. Various services provided by TMDA along with fees has been summarized on TMDA website: www.tmda.go.tz.

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