Guidelines on Submission of Documentation for Registration of Human Vaccines

Introduction

This guideline, developed by the Pharmacy and Poisons Board (PPB), provides a comprehensive framework for the evaluation and registration of human vaccines in Kenya. It brings together both national and regional regulatory requirements to ensure that all vaccines meet established standards of quality, safety, and efficacy.

While the document primarily addresses individual vaccines, its principles may also apply to combination vaccines, even if not explicitly mentioned. Applicants are encouraged to use this guideline alongside relevant international standards issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH), all of which are referenced throughout the text.

Main content

This guideline outlines the requirements for structuring applications in accordance with the Common Technical Document (CTD) format, which includes the following modules:

• Module 1: Administrative and prescribing information
• Module 2: Quality overall summaries
• Module 3: Quality information (chemical, pharmaceutical, and biological data)
• Module 4: Non-clinical study reports
• Module 5: Clinical study reports

In addition, vaccine-specific requirements have been provided to guide applicants in preparing submissions tailored to the type and complexity of the vaccine in question.