Guidelines on Submission of Documentation for Registration of Human Vaccines

These guidelines have been developed to provide guidance to applicant for marketing authorization of human vaccines in the Kenya .

The work has been compiled by the East African Community (EAC) Experts Working Group (EWG) on Medicines Evaluation and Registration. The team relied on their experiences and knowledge on biotechnology manufacturing including specific requirements for vaccines of the respective Partner States individual countries, World Health Organization (WHO) and other key partners in the biotechnology sector.

The guidelines therefore provide product dossier requirements in support of market authorization of vaccines. One of the means for ensuring that products meet the required standards of quality, safety and efficacy is by conducting product specific pre-marketing assessments to determine whether the product should be registered. Submission of adequate documentation on quality, safety and efficacy of a vaccine will enable Pharmacy and Poisons Board to use the information and other factors to assess the suitability of the product for the intended use.

Compliance to these guidelines in the submission of applications will facilitate processing of applications and subsequent registration of the products. This will enable the product to be available to the consumers in a timely manner.

Pharmacy and Poisons Board exercises adequate regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. It should be noted that vaccines differ from chemical drugs because of the biological nature of the source materials (such as those derived from microorganisms and viruses), the biological methods used to test them, the lack of a classical pharmacokinetic measurable mode of action and because they are highly complex substances. Some vaccines consist of live microorganisms suitably changed or attenuated to ensure that they no longer produce disease but can still produce a suitable immune response. Special expertise and procedures are needed for their manufacture, control, and regulation..

Before a vaccine is considered for approval, sufficient scientific and clinical evidence must be collected to show that it is safe, efficacious and of suitable quality. This scientific evidence includes results from human clinical trials and for acceptance; it should be evident that the benefits of the vaccine outweigh any risks associated.

When all above is in place, additional mechanisms like: Risk-based lot release program, Post-market changes, Post-market surveillance for compliance verifications as well as investigations of potential health hazards and other violations should be implemented.

Furthermore, regular inspections of manufacturers, packagers/labellers, testing laboratories, importers, distributors and wholesalers of vaccines may be conducted to ensure that they comply with Good Manufacturing Practices

(GMP). Alternatively, available and reliable evidence of compliance and non- compliance with good practice requirements can be leveraged as part of the risk-based inspection planning process as prescribed in the WHO guidance on good practices for desk assessment. These guidelines prescribe data, which is required to be submitted to Pharmacy and Poisons Board to demonstrate the safety, efficacy and quality of vaccines being applied for market authorization. The guidelines also describe the format in which dossiers should be presented in support of the application. According to the CTD format, each application is a collection of documents, grouped into 5 modules. Module 1 prescribes Administrative Information and Prescribing Information requirements, which is region specific. The Overviews and Summaries, Quality, Non-clinical, and Clinical modules have been described in Modules 2 to 5, respectively.

These guidelines should be read in conjunction with other international guidelines on quality, safety and efficacy as cited in this guideline namely the World Health Organization (WHO), European Medicines Agency (EMA) and International Conference of Harmonization (ICH).