Snapshot

The Emergency Use Application (EUA) pathway has been developed by the Pharmacy and Poisons Board (PPB) of Kenya.

This pathway can be used where The product categories to be reviewed under emergency use will include but not be limited to: (a) Medicines (therapeutics): I. Blood and Blood Product; II. Biotherapeutic products; and III. Chemical products. (b) Vaccines. (c) Medical devices & In-vitro diagnostics (IVDs). The product categories would each have specific requirements for eligibility for evaluation under the EUA procedure. 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 products may also be an antidote that may be effective to mitigate disease or conditions caused by use of an already registered product. c) The potential benefits of the product must outweigh potential risks. d) The product is manufactured in compliance with Good Manufacturing Practices (medicines & Vaccines) and under a functional Quality Management system (ISO standards) in the case of IVDs and Medical devices, and e) Where applicable, the applicant undertakes to complete the development of the product (clinical trials in case of medicines & vaccines, and validation and verification in case of IVDs) and subsequently apply for registration of the product..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Brazil Canada China EU-EMA East African Community (EAC) Iceland Intergovernmental Authority on Development (IGAD) Region Japan Liechtenstein Mexico Norway Saudi Arabia Singapore South Korea Switzerland Turkey United Kingdom United States WHO

Approval timelines shall be determined on a case-by-case basis. In general, the approval timelines for abridged and WHO EUL listed product applications shall be evaluated within 7 calendar days of submission of complete documentation. For initial assessment application (undergoing full assessment pathway), an application shall be reviewed within 30 calendar days. Any subsequent additional information shall be reviewed within 7 calendar days. Screening for eligibility shall be accomplished within 7 calendar days.