Snapshot

The Reliance for Regulatory Decision Making in Kenya pathway has been developed by the Pharmacy and Poisons Board (PPB) of Kenya.

This pathway can be used where The Pharmacy and Poisons Board may apply reliance procedures for granting Marketing Authorization or Emergency Use Authorization (EUA) in the following situations: (a) Product should have been evaluated and listed as a WHO Prequalified Product or Emergency Use Listed (EUL) product; (b) The applicant should have granted authorization for access of assessment reports by, for instance, signing and sharing the requisite WHO PQ collaborative procedure documentation e.g. appendix 2 and 3 of the WHO Collaborative procedure; (c) Product should have been evaluated and listed as a product of either the WHO collaborative procedure pilot for products authorized by Stringent Regulatory Authorities, including through the European Union (EU) Article 58 Procedure or the Swissmedic Marketing Authorization for Global Health Products (MAGHP) or the International Generic Drug Regulatory Programme (launched July, 2014); (d) The products should have been approved, registered and or granted marketing Authorization or EUA by either an ICH founding regulatory member state or region [such as EMA (both centralized and decentralized procedure, United States Food and Drugs Administration, Japan (MHLW/PMDA) or an ICH standing regulatory member state or region (such as Health Canada, Swissmedic), Therapeutic Goods Administration (TGA), Australia, Medicines and Health Products Regulatory Agency (MHRA), UK; (e) The product should have been jointly evaluated and listed as an output of the East African Community (EAC) or IGAD or any regional grouping that Kenya is party to. The applicant will be required to submit the accepted dossier by EAC or IGAD MRHs, payment of requisite fees (product registration and GMP inspection) and provide EAC MRH or IGAD Approval letter or certificate; (f) Products registered by WHO listed agencies may be considered through the reliance mechanism; (g) Any bilateral Cooperation between Kenya and foreign governments; (h) Products in which the drug substance/API used has a Valid CEP or its Prequalified by WHO; (i) In all Circumstances, assessment reports shall be shared to PPB by the Reference Regulatory Authority or WHO on authorization by the applicant; (j) The shared assessment reports shall form part of PPB’s assessment reports..

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

When relevant, the agency relies on prior decisions from Argentina Australia Austria Belgium Canada Croatia Cyprus Czech Republic Denmark EU-EMA East African Community (EAC) Estonia Finland France Germany Greece Hong Kong Hungary Iceland Intergovernmental Authority on Development (IGAD) Region Ireland Israel Italy Japan Latvia Liechtenstein Lithuania Luxembourg Malta Netherlands New Zealand Norway Poland Portugal Romania Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Kingdom United States WHO

The authority reserves the right to subject all submissions for approval to an ‘abridged’ evaluation of a certain part of the application (e.g., relevant to use under local condition) such as product quality data in relation to climatic conditions and distribution infrastructure and a benefit-risk assessment in relation to use in the local ethnic population, medical practice/culture and patterns of disease and nutrition. Depending on the type verification, the applications will be evaluated within a time line of not exceeding 90 calendar days of regulatory time from the date after obtaining assessment and inspections outcomes (reports) or not exceeding 7 working days for the purpose of granting an Emergency Use Authorization (EUA). Regulatory time starts after a valid application according to the Procedure has been received and access to the confidential information has been granted (whichever is the later) and continues until the date of decision by PPB. The regulatory time does not include the time granted to the applicant to complete missing parts of the documentation, provide additional data or respond to queries raised by PPB.