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Guidelines on Medicines Evaluation and Registration
Guidelines on submission of documentation for registration of Similar Biotherapeutic products
Guidelines on submission of documentation for registration of Biotherapeutic products
Strategies for clearing Backlog of marketing authorization applications
Guidance on the Framework for Implementation of Bio-Equivalence in Kenya
Vaccine Variation guideline
Guideline for Renewal and Re-registration of Marketing Authorization
Guidelines on Vaccines Registration
Guidelines on Herbals and complementary medicines registration
Guideline for Suspension, withdrawal or Revocation of Marketing
Guideline for Variation of Registered Human Products
Guideline for Emergency or Compassionate Use Application
Guidance on Reliance for Regulatory Decision Making in Kenya
Guidelines for Registration of Medical Devices Establishments
Compendium of Medicines Evaluation and Registration for Medicine Regulation Harmonization in The East African Community
Guidelines for Registration of Medical Devices Including In-Vitro Diagnostics
Application For Registration of Human Vaccine Product
Application Form for Registration of Biotherapeutics and Similar Biotherapeutic Products
Application Form for Medicine Registration
Bioequivalence Trial Information (BTIF) form
Biowaiver Application Form
Quality Overall Summary – Product Dossier (QOS- PD)
Application Form for Variation to a Registered Pharmaceutical Products
