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 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
Target time assessment is 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..