Snapshot

The Emergency Use Authorization of Medicinal Products pathway has been developed by the Tanzania Medicines & Medical Devices Authority of Tanzania.

This pathway can be used where The Minister responsible for Health shall declare a public health emergency pursuant to the Public Health Act, 2009 or an emergency declared as per the scenarios presented under section 6.1 of the referenced guideline when a situation which poses an immediate risk to health, life, property or the environment arises. To meet the criteria for a public health emergency, the incident may include but not limited to: - (a) Immediately threaten life, health, property or the environment; (b) Have already caused loss of life, health detriments, property damage or environmental damage; or (c) Have a high probability of escalating to cause immediate danger to life, health, property and the environment. In order to qualify for assessment under the EUA procedure the following criteria must be met: - (a) The disease for which the product is intended is serious, immediately life threatening or has the potential of causing an outbreak, an epidemic or pandemic and there are no registered products for the indication or for a critical subpopulation.; (b) Existing products have not been successful in eradicating the disease or preventing outbreaks. Potential EUA product may also be an antidote that may be effective to mitigate disease or condition caused by use of an already registered product; (c) The potential benefits of the product must outweigh potential risks. Products are eligible for Emergency Use Authorization (EUA.), if TMDA determines that the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product. In determining whether the known and potential benefits of the product outweigh the known and potential risks, the Authority intends to assess the quality and quantity of the evidence, given the current state of scientific knowledge, of risks and benefits; (d) The product is demonstrated to be manufactured in compliance with Good Manufacturing Practices (medicines and vaccines); and (e) The applicant undertakes to complete the development of the medicinal products (Clinical Trials, Chemistry, Manufacturing and Control data) before subsequently applied for marketing authorization of the product. Applications for EUA submission includes candidates from the pharmaceuticals, biologicals including vaccines. Examples may consist: - (a) Use of unapproved indication for a registered product; (b) New Investigational product under EUA (refer also to TMDA’s Clinical Trials Guidelines); and (c) Unregistered products. It should be noted that, the three product categories above would each have specific requirements for eligibility for evaluation under the EUA procedure. The Authority may consider reviewing a candidate product for EUA that does not meet all the requirements; this must be justified (e.g., in case it is the only option available at the time of the public emergency) .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from ASEAN Algeria Argentina Armenia Australia Austria Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Tunisia Turkey Ukraine United Kingdom United States WHO

Upon submission of application, screening of the application will be conducted for acceptance of application. Successful applications will proceed for evaluation under the EUA. If no screening queries are raised the application will be recommended for emergency use authorization. After the initial submission of the EUA procedure, application with all the mandatory information for initial assessment, applicants are requested to promptly submit any additional information on the development of the product to TMDA. Any unsatisfactory application may be rejected upon screening or unsatisfactory response. An applicant may request for withdrawal of the application after screening, before evaluation, during query response and after unsatisfactory query response. Applicants of rejected applications may appeal to the Authority as per the existing appeal process. The emergency use authorization shall be subject to but not limited to the following conditions: - (a) The emergency use authorization will automatically terminate upon declaration of end of public health emergency; (b) The applicant shall adhere to all commitments including additional data updates, continued clinical studies, safety reports, risk management plans and adherence to advertisements and/or promotions, regulatory requirements and safety and vigilance guidelines on medicinal products; and (c) After declaration of the end of the public health emergency and based on the outcome of the continued studies, the applicant will be expected to submit a complete dossier for the evaluation for marketing authorization. Screening, assessment and approval timelines shall be determined on a case by case basis and may be as short as deemed possible. However, the following general timelines are applicable: Receiving and screening = 2 working days; Evaluation under national procedure = 15 working days; Evaluation under reliance procedures = 10 working days; Evaluation of Query responses = 10 working days; Review by Technical committee = 3 working days; Approval process = 5 working days. Therefore, Total Regulatory Time = 45 working days. NOTE: The clock starts when the Authority receives a completed document. Applicant’s time are excluded in the above timelines.